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Long-Term Outcomes and Cost-Effectiveness of an Internet-Based Self-Help Intervention for Social Anxiety Disorder in University Students: Results of a Randomized Controlled Trial

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Depression and Anxiety
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Social anxiety disorder (SAD) is widespread among university students and is associated with high costs for the society. While unguided internet- and mobile-based interventions (IMIs) may have short-term effects in reducing SAD symptoms, evidence for their long-term efficacy and cost-effectiveness is still limited. The aim of this study is to examine the 6-month outcomes of an IMI for university students with SAD. Participants were recruited via mass mails sent to enrolled students and included if they were at least 18 years old, met the diagnostic criteria of SAD in a structured clinical interview for DSM-IV axis I disorders (SCID-I), and provided written informed consent. In a prospective study designed as a two-armed randomized-controlled trial, 200 students (mean age 26.7 years) diagnosed with SAD were randomly assigned to an IMI or a waitlist control (WLC) condition. The IMI consisted of nine weekly sessions based on the cognitive-behavioral treatment model for social phobia by Clark and Wells. The primary outcome was SAD symptom severity assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). A health economic evaluation from a societal and healthcare perspective examined the costs related to the symptom-free status and quality-adjusted life years (QALYs) gained. Statistically significant differences in SAD symptom severity previously found at posttreatment favoring the IMI were maintained at a 6-month follow-up [SIAS (Cohen’s d = 0.59 ; 95% CI, 0.30, 0.87) and SPS (Cohen’s d = 0.83 ; 95% CI, 0.54, 1.1)]. From a societal perspective, at a willingness to pay (WTP) of €0, the intervention was found to have a 92% and 93% probability of cost-effectiveness compared with the WLC per symptom-free status and QALY gained, respectively. From a healthcare perspective, the likelihood of cost-effectiveness of the intervention was 97% per symptom-free status at a WTP of €1000 (US$1326) and 96% per QALY gained at a WTP of €6000 (US$7956). This IMI is effective in treating university students with SAD and has an acceptable likelihood of cost-effectiveness compared with WLC from a societal perspective. This intervention can be integrated into university healthcare to reach students with SAD as it is scalable, shows a high probability of cost-effectiveness, and overcomes known treatment barriers. This trial is registered with DRKS00011424.
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Research Article
Long-Term Outcomes and Cost-Effectiveness of an Internet-
Based Self-Help Intervention for Social Anxiety Disorder in
University Students: Results of a Randomized Controlled Trial
Fanny Kählke ,
1
Claudia Buntrock ,
2
Filip Smit ,
3
Thomas Berger ,
4
Harald Baumeister ,
5
and David Daniel Ebert
1
1
School of Medicine and Health, Department Health and Sport Sciences, Professorship for Psychology and Digital Mental
Health Care, Technical University Munich, Munich, Germany
2
Institute for Social Medicine and Health Systems Research, Otto-von-Guericke-Universität Magdeburg, Magdeburg, Germany
3
Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit,
Amsterdam, Netherlands
4
Department of Clinical Psychology and Psychotherapy, Universität Bern, Bern, Switzerland
5
Department of Clinical Psychology and Psychotherapy, Ulm University, Ulm, Germany
Correspondence should be addressed to Fanny Kählke; fanny.kaehlke@tum.de
Received 24 May 2023; Revised 31 July 2023; Accepted 21 September 2023; Published 17 November 2023
Academic Editor: Giulia Landi
Copyright © 2023 Fanny Kählke et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Social anxiety disorder (SAD) is widespread among university students and is associated with high costs for the society. While
unguided internet- and mobile-based interventions (IMIs) may have short-term eects in reducing SAD symptoms, evidence
for their long-term ecacy and cost-eectiveness is still limited. The aim of this study is to examine the 6-month outcomes of
an IMI for university students with SAD. Participants were recruited via mass mails sent to enrolled students and included if
they were at least 18 years old, met the diagnostic criteria of SAD in a structured clinical interview for DSM-IV axis I disorders
(SCID-I), and provided written informed consent. In a prospective study designed as a two-armed randomized-controlled trial,
200 students (mean age 26.7 years) diagnosed with SAD were randomly assigned to an IMI or a waitlist control (WLC)
condition. The IMI consisted of nine weekly sessions based on the cognitive-behavioral treatment model for social phobia by
Clark and Wells. The primary outcome was SAD symptom severity assessed via the Social Phobia Scale (SPS) and the Social
Interaction Anxiety Scale (SIAS). A health economic evaluation from a societal and healthcare perspective examined the costs
related to the symptom-free status and quality-adjusted life years (QALYs) gained. Statistically signicant dierences in SAD
symptom severity previously found at posttreatment favoring the IMI were maintained at a 6-month follow-up [SIAS (Cohens
d=059; 95% CI, 0.30, 0.87) and SPS (Cohensd=083; 95% CI, 0.54, 1.1)]. From a societal perspective, at a willingness to pay
(WTP) of 0, the intervention was found to have a 92% and 93% probability of cost-eectiveness compared with the WLC per
symptom-free status and QALY gained, respectively. From a healthcare perspective, the likelihood of cost-eectiveness of the
intervention was 97% per symptom-free status at a WTP of 1000 (US$1326) and 96% per QALY gained at a WTP of 6000
(US$7956). This IMI is eective in treating university students with SAD and has an acceptable likelihood of cost-eectiveness
compared with WLC from a societal perspective. This intervention can be integrated into university healthcare to reach
students with SAD as it is scalable, shows a high probability of cost-eectiveness, and overcomes known treatment barriers.
This trial is registered with DRKS00011424.
Hindawi
Depression and Anxiety
Volume 2023, Article ID 7912017, 16 pages
https://doi.org/10.1155/2023/7912017
1. Introduction
Social anxiety disorder (SAD) is a prevalent and impairing
disorder and is considered a public health concern. In partic-
ular, university students fall within the age range when com-
mon mental health problems reach their developmental
peak [1]. Being at a university is associated with many
stressors and transitional events [2]. In Germany, persons
aged 1835 show a 4.8% [3] 12-month prevalence of SAD,
while 12.2% of university students show clinically relevant
social phobic symptoms [4]. Several adverse eects on qual-
ity of life (QoL) and identity formation [5], alcohol con-
sumption [6], and suicidal ideation [7] are reported in
university students with SAD. These may lead to premature
dropout and academic underachievement [8]. Moreover,
SAD is associated with substantial impairment across several
domains, such as relationship, daily and social life, and work
[9]. Altogether, it generates direct (treatment), indirect (pro-
ductivity losses, absence of work, and low qualication [10,
11]), and intangible costs (lower QoL and social impair-
ment). In Germany, the mean total 6-month costs for SAD
in a clinical sample were estimated at 4802 per person,
which are mainly attributed to indirect cost [12].
While the university setting enables comprehensive
approaches for prevention, early intervention, and treatment
of students with SAD, students in general are averse to face-
to-face counseling centers preferring to solve their problems
themselves [13]. In particular, students with SAD face attitu-
dinal barriers (fear of stigmatization and negative evalua-
tion) to help-seeking [14] that may leave them untreated
with a chronic condition [15].
Internet- and mobile-based interventions (IMIs), which
are exible, accessible, and anonymous [1618], present a
promising approach to reach those aected individuals.
Unguided IMIs have received adequate attention owing to
their potential for high scalability and relatively low mar-
ginal costs. The ecacy of unguided IMIs based on
cognitive-behavioral approaches targeting SAD has been
shown with medium eects at posttreatment compared with
that of passive controls (g=078, 95% CI [0.501.05], SE
=014,p<0001,k=5). However, in contrast to guided
IMIs, the evidence for the long-term ecacy of unguided
IMIs is still limited [1922].
Moreover, the value of IMIs for SAD in university stu-
dents has not been suciently investigated. Existing evi-
dence suggests that IMIs targeting SAD in university
students might have benecial eects up to one year with
or without guidance [2325]. However, the evidence base
is weak because studies mainly focused on fear of public
speaking [23, 25], had substantial dropout rates [24, 25],
and were underpowered [23].
Apart from the ecacy of IMIs for SAD, evidence to
support their cost-eectiveness is still insucient. While
the assessment of the ecacy takes the benets for patients
into account, the assessment of economic consequences also
considers a wider perspective by providing insights into soci-
etal costs and benets. Only three studies investigated the
economic merits of IMIs for SAD, indicating that guided
[2628] and unguided [29] IMIs may be a cost-eective
treatment option in the long term (6 months) in the gen-
eral population. However, it should be considered that evi-
dence is still limited due to high dropout rates [29], few
statistical analyses, and the absence of a full health economic
evaluation [28].
Previously published results of this study (10 weeks after
randomization) showed that IMI was superior to a waitlist
control (WLC) group in reducing SAD symptom severity
in university students with moderate to large eect sizes
[30]. In this study, we report its clinical eects at 6-month
follow-up and the health economic outcomes from a societal
and public healthcare perspective over a 6-month period.
2. Methods
2.1. Study Design and Participants. A two-arm randomized
controlled design was used to allocate 200 participants
(block size of 8, varying ratio) to either the intervention
(IMI) or control (WLC) group [31]. Alongside this trial, a
cost-eectiveness analysis was conducted. An independent
investigator randomized participants applying the RandList
program [32]. Self-reported measurements were collected
over three measurement points using a secured web-based
assessment system (UNIPARK [33], 256-bit encrypted): at
baseline (T0), posttreatment (T1; 10 weeks after randomiza-
tion), and 6-month follow-up (T2) (Figure 1). The partici-
pants were recruited via e-mails sent to enrolled students
at universities in Switzerland (N=3), Austria (N=2), and
Germany (N=8) from January 2017 to February 2018.
The applicants met the following inclusion criteria: they
were 18 years or older, scored >21 on the Social Phobia Scale
(SPS) and/or>32 on the Social Interaction Anxiety Scale
(SIAS), met the diagnostic criteria of SAD according to the
structured clinical interview for DSM-IV axis I disorders
(SCID-I), and provided written informed consent. The inter-
views were conducted by trained interviewers via telephone
[34]. The exclusion criteria included individuals at risk of
suicide, showing dissociative symptoms, being diagnosed
with psychosis, or currently undergoing psychotherapy.
The Ethics Committee of the Friedrich-Alexander-
University Erlangen-Nuremberg, Germany, approved the
study. The trial was registered in the German clinical trial
registry (DRKS00011424) on December 14
th
, 2016. More
details on the study design, diagnostic interview, and partic-
ipants can be found in the study protocol [31].
2.2. Intervention. The intervention consisted of nine weekly
sessions (approx. 60 minutes each) based on the cognitive-
behavioral treatment of Clark and Wells [35, 36]. It con-
tained text-based information material, various exercises
(e.g., attention training), and diaries (e.g., identifying and
questioning negative thoughts). The sessions were based
on motivational enhancement (Session 1); psychoeducation
(Session 2); identication and modication of negative
thoughts through a thought diary (Sessions 3) and
cognitions related to fear of positive evaluation (FPE) (Ses-
sion 4); exercises to reduce self-focused attention, includ-
ing behavioral experiments, such as in vivo exposures
(Sessions 57); healthy lifestyle and problem-solving skills
2 Depression and Anxiety
(Session 8); and relapse prevention (Session 9). The focus
on FPE reected a new treatment element that included
the core components of SAD: fear of negative and positive
evaluation [37]. A detailed description of the intervention
can be found elsewhere [31].
3. Outcome Measures
3.1. Primary Outcome. The level of social anxiety was mea-
sured by the SPS and the SIAS [38]. These two self-report
questionnaires complement each other and are usually
administered together. The SIAS assesses more general fears
of social interaction, whereas the SPS focuses on fears of
being judged by others during daily activities. Each scale
consists of 20 items rated on a 5-point Likert scale
(0 = not at allto 4 = extremely). These two scales have
been found to be valid, reliable, and useful for clinical and
research purposes [39]. Cronbachsαfor the SIAS and SPS
ranged from 0.90 to 0.94 [40] (current sample, α=0 91
0 93). Symptom-free status was operationalized as scoring
17 on the SPS and 26 on the SIAS [41]. Stangier et al.
[38] proposed these cut-ovalues to dierentiate between
social phobic cases and non-social phobic cases. Diagnostic
status was assessed via a diagnostic interview (SCID-I) by
955 individuals applied to participate
Positive screening (n = 425)
Randomization (n = 200)
StudiCare SAD (n = 100)
Unguided self-help intervention: 10 weeks training
Did not complete screening questionnaire (n = 352)
Did not send in written informed consent (n = 175)
Not reached for SCID interview (n = 34)
(i)
(ii)
Provided data: n = 91 (91%)
Lost to assessment: n = 9 (9%)
SCID-I interview (n = 216)
Screening
Enrollment
Allocation
Follow-up
Assessment I (n = 200)
Analysis
Analyzed: n = 100 excluded (n = 0)
Follow-up
Analysis
Analyzed: n = 100 excluded (n = 0)
Did not fulfill initial inclusion criteria (n = 178)
Excluded after SCID-I interview (n = 16)
(i)
(ii)
(iii)
(iv)
(v)
(vi)
SPS and/or SIAS below cut-off (n = 109)
Age < 18 (n = 3)
Not enrolled as a student (n = 39)
Ongoing psychological treatment (n = 22)
Suicidal risk (n = 7)
Insufficient knowledge of German (n = 2)
(i)
(ii)
(iii)
No diagnosis of SAD according to SCID (n = 10)
SAD not the primary diagnosis (n = 5)
Suicidal ideation (n = 1)
(i)
(ii)
Provided data: n = 68 (68%)
Lost to assessment: n = 32 (32%)
Assessment II (10 weeks after randomization)
Assessment III (6 months after randomization)
Waitlist control group (n = 100)
Analyzed: n = 100 excluded (n = 0)
Analyzed: n = 100 excluded (n = 0)
Provided data: n = 94 (94%)
Lost to assessment: n = 6 (6%)
Assessment II (10 weeks after randomization)
(i)
(ii)
Provided data: n = 87 (87%)
Lost to assessment: n = 13 (13%)
Assessment III (6 months after randomization)
Figure 1: Flow of participants.
3Depression and Anxiety
an interviewer blinded to the treatment condition after 6
months. Interrater reliability was evaluated in 20% of ran-
domly selected participants.
3.2. Secondary Outcomes. The secondary outcomes are as
follows:
(i) Symptoms of social anxiety (the Liebowitz Social
Anxiety Scale [LSAS-SR] assesses fear and avoid-
ance in 24 dierent situations) [42] (Cronbachsα
=095 in the current sample)
(ii) Fear of positive evaluation (Fear of Positive Evalua-
tion Scale [FPES] showing good psychometric prop-
erties in clinical and healthy samples [10 items] [43,
44] [α=079], Disqualication of Positive Social
Outcomes Scale [DPSOS] [13 items] [45] [α=090
])
(iii) Depressive symptoms (Beck Depression Inventory
II [BDI-II] [21 items] has shown high reliability
and validity in SAD clients) [36, 46] (α=091)
(iv) General psychopathology (Brief Symptom Inven-
tory [BSI] [53 items, 9 dimensions] and Global
Severity Index [GSI] as overall mean score reported
and robust psychometric properties) [47, 48]
(α=096)
(v) Interpersonal problems (Inventory of Interpersonal
Problems [IIP-64] [8 dimensions] has shown ade-
quate psychometric properties) [49, 50] (α=096)
4. Health Economic Evaluation
4.1. Quality-Adjusted Life Years (QALYs). QALYs were com-
puted using the Assessment of Quality of Life (AQoL-8D)
and the EuroQol (EQ-5D-5L) instruments. The AQoL-8D
assesses eight dimensions (independent living, pain, senses,
mental health, happiness, coping, relationships, and self-
worth) and is a reliable and valid instrument [51] with Cron-
bachsαof 0.96. The EQ-5D-5L is a widely applied, valid,
and reliable measurement of QoL [52]. It consists of ve
items on a 5-point Likert scale related to mobility, self-care,
common activities, pain/discomfort, and anxiety/depression.
Utility values were derived using instrument-specic utility
weights (EQ-5D [53] and AQoL [54]). QALYs were calcu-
lated using the area-under-the-curve (AUC) method of line-
arly interpolated utilities between measurements to cover the
whole 6-month follow-up period. The EQ-5D was only used
for sensitivity analyses.
4.2. Costs. We retrospectively assessed the 3-month
healthcare costs, productivity losses, and patient and family
costs using the Trimbos Institute and Institute of Medical
Technology Questionnaire for Costs Associated with Psychi-
atric Illness(TiC-P) adapted to the German healthcare sys-
tem [55]. The TiC-P is a frequently used and reliable self-
report instrument for healthcare utilization and productivity
losses among (German) [56, 57] patients with mental ill-
nesses [58]. For each participant, the units of resource use
were multiplied by the standard unit cost prices [59]. The
interventions market price was estimated at 150
(US$198.89) per participant, reecting costs due to mainte-
nance and hosting. In addition to the German value added
tax of 19%, the interventions costs were 178.50
(US$236.68). It was presumed that each participant had a
computer and internet access. The costs of therapeutic appli-
ances and medication were obtained from the Lauer-Taxe
[60] and calculated according to the method of Bock et al.
[59]. German healthcare costs were last published in 2011
and therefore indexed from 2011 to 2017 (index factor of
1.09) according to the German consumer price index [61].
Costs stemming from productivity losses through absen-
teeism and presenteeism were only assessed in students who
had a paid job. Using the human capital approach [62],
absenteeism costs were calculated as the number of working
days lost due to illness multiplied by the average gross daily
wage of the students monthly salary. Presenteeism was
determined based on an ineciency score (Osterhaus
method [63]) multiplied by the number of working days
aected. Then, costs of presenteeism were calculated based
on the students gross daily wages. Productivity losses gener-
ated by unpaid work, such as daily chores, were valued using
a shadow price of 19.63 (US$26.03) per hour for domestic
help. Table S1 shows additional costing information.
The AUC method was applied to estimate cumulated
costs by linearly interpolating costs over a 3-month period
measured at baseline, post, and follow-up to cover the entire
6-month follow-up period [64]. All costs were expressed in
Euros () for 2017 (December), the year in which the study
was conducted. Purchasing power parities based on the
Organization for Economic Cooperation and Development
were used to convert costs to US dollars [65] (reference year:
2017; 1 was equated to US$1.33). The resource utilization
in Austria and Switzerland was valued using German stan-
dard unit cost prices to increase consistency in costs and
minimize confounding.
4.3. Evaluation of Clinical Outcomes. This study was con-
ducted to detect a mean standardized dierence of d=040
in the primary outcomes (SPS/SIAS) between the groups at
post-measurement [31]. The results were reported according
to the Consolidated Standards of Reporting Trials statement
[66] using intention-to-treat (ITT) procedures. Missing clin-
ical outcome data were imputed by applying a Markov
Chain Monte Carlo multivariate imputation algorithm with
10 estimations per missing value [67].
The evaluation of the clinical outcomes was performed
using the SPSS software [68]. The IMI and WLC were com-
pared six months after randomization (T2) using analysis of
covariance (ANCOVA) with baseline levels as covariates. Due
to the violation of normally distributed error terms of many
outcomes, robust ANCOVA was used [69]. These analyses were
adjusted for multiple testing. Hence, αwas set at a level of
<0.025 [70] for testing the primary outcomes and <0.05 for all
other tests. Cohensdwith 95% CIs was calculated.
Treatment response and clinically signicant deteriora-
tion were dened by the Reliable Change Index [38]. The
participants were dened as reliably improved if their SPS
4 Depression and Anxiety
(SIAS) score declined from baseline to 6-month follow-up
with more than 1.96 standard units, while also considering
the reliability of the measurement instruments to compensate
for random measurement error. The participants met the cri-
teria for reliable change when they had improved (deterio-
rated) at least 7.03 points on the SPS and 9.53 points on the
SIAS. Moreover, the participants were rated as symptom-free
if they scored 17 or below on the SPS and 26 or below on
the SIAS [38]. To further guide the clinical interpretation,
the numbers needed to treat (NNT) were calculated [71, 72].
Dierences in symptom-free status, reliable change, and diag-
nostic status as assessed by SCID interviews between the
groups were assessed at follow-up using the chi-squared test.
4.4. Health Economic Evaluation. The evaluation adhered to
standards set by the Consolidated Health Economic Evalua-
tion Reporting Standard (CHEERS) and International Soci-
ety for Pharmacoeconomics and Outcomes Research
(ISPOR RCT-CEA Task Force Report) [73, 74].
All data was analyzed based on the ITT principle. Thus,
missing cost data was imputed using the regression imputa-
tion procedure using the predictors of the outcome (e.g.,
baseline costs, annual gross salary, and status of employ-
ment) and dropout rate (e.g., sex and age) that were identi-
ed via logistic regression analysis.
The ordinary least square (OLS) regression was used to
estimate QALYs while controlling for baseline utility values.
From a societal and public healthcare perspective, cost cate-
gories and cost per study arm were evaluated by OLS regres-
sion models. One cost outlier was identied by calculating
the Mahalanobis distance based on the total cost (N=1,in
the WLC) and handled using winsorization where it was
substituted by the value at the 99th percentile [75]. No dis-
counting of costs and eects was applied because the
follow-up period did not exceed one year. The incremental
cost-eectiveness ratio (ICER) displays the incremental costs
per unit of the eect (QALY, symptom-free status). The
ICER was calculated as ICER = costsIMI costsWLC / effect
sIMI effectsWLC , where the costs are cumulated over a
period of 6 months and effects are reected by the
symptom-free status or QALY gains.
For our economic analyses, we applied a probabilistic
decision-making approach [76] that accounts for stochastic
uncertainty [77] in the study data. It provides the decision-
maker with information about probabilities rather than sta-
tistical signicance. A 5000-fold bootstrapped seemingly
unrelated regression equation model on costs and eects
was used to generate the incremental costs and eects, while
adjusting for baseline utilities, age, and prior psychotherapy
[78]. The 5000 bootstrap replications of cost-and-eect pairs
were used to obtain 95% condence intervals and plotted in
a cost-eectiveness plane. The plane depicts the incremental
eects between the intervention and control group on the x
-axis and the incremental costs between the groups on the y
-axis. The intervention dominatesthe control groups if
better eects are obtained for lower costs. Hence, the major-
ity of simulated ICER falls in the southeast quadrant. In con-
trast, in the northwest quadrant, the intervention is
inferiorto the control group as higher costs are associated
with worse health outcomes. Thus, it is not considered cost-
eective [62]. In the southwest quadrant, an intervention is
less eective and less costly than the control group. On the
other hand, in the northeast quadrant, an intervention is
more eective and more costly than the control condition.
Here, the amount of money a decision-maker is willing to
pay for one additional positive outcome determines the
adoption of a new intervention. A cost-eectiveness accept-
ability curve was displayed that indicates the probability of
cost-eectiveness of an IMI at varying WTP ceilings, given
that there is no common threshold for gaining one unit of
health (e.g., symptom-free status). Analyses were carried
out with Stata version 16.1 [79].
4.5. Sensitivity Analyses. The sensitivity analyses were con-
ducted to inspect the robustness of our results. First, the data
of the participants who completed the 6-month follow-up
assessment were analyzed. Second, changing market prices
can lead to varying intervention costs, which explains why the
increased intervention costs were examined (+50%, 100%).
Third, Swiss students (n=40, 20%) were excluded to validate
the robustness of the ndings. Their number and employment
rate were balanced across groups, but dierences in healthcare
settings and salaries could have biased the results. Fourth, to
facilitate comparability across studies, the widely applied EQ-
5D instrument was used to generate QALYs. Lastly, the diag-
nostic status as a meaningful eect outcome for policymakers
was used for the cost-eectiveness analysis.
5. Results
5.1. Sample. Thesamplepredominatelyconsistedoffemale
(n=124, 62%) German university students (n=150,75%)aged
27 (SD 6.34) (Table S2). A comprehensive description of the
study sample and the participant ow can be found elsewhere
[31]. We did not observe any clinically relevant baseline
dierences between the study conditions. The dropout rates
between IMI (n= 32/100,32%)andWLC(n= 13/100, 13%)
diered signicantly (χ2=1035;df = 1;p<001), yet the
dropout rate was not associated with the sociodemographic
factors or the baseline SAD symptoms. The attrition rate was
22.5% (45/200) at the 6-month follow-up.
5.2. Outcome Measures. As shown in Table 1, the IMI was
associated with lower scores on both primary outcome mea-
sures than WLC. These between-group dierences were sta-
tistically signicant: SPS, F1, 197 =5501,p<0001; SIAS,
F1, 197 =4903,p<0001. The corresponding standard-
ized eect sizes were moderate for SIAS (d=059, 95% CI
[0.30, 0.87]) and large for SPS (d=083, 95% CI [0.54,
1.10]). Fewer participants in the IMI (n= 30/100) than in
the WLC (n= 60/100) presented with a clinical diagnosis
of social phobia assessed through a SCID interview
(χ2=1818;df = 1;p<0001). The inter-rater reliability
showed substantial agreement (Cohenskappa,κ=078 [80]).
5.3. Treatment Response, Symptom-Free Status, and
Symptom Deterioration. After 6 months, signicantly more
participants in the IMI showed a reliable improvement and
achieved a symptom-free status compared with those in
5Depression and Anxiety
the WLC based on the SPS and the SIAS. Likewise, the clin-
ically signicant deterioration was lower in the IMI com-
pared with the WLC for both outcomes (Table S3).
5.4. Secondary Outcome Analyses. Table 2 shows the results
for the secondary outcomes, interpersonal problems, depres-
sion, somatic symptoms, FPE, and QoL. Signicant between-
group dierences for all outcomes, except the EQ-5D, with
eect sizes ranging from d=023 (95% CI [0.05, 0.50]) for
the AQoL to d=076 (95% CI [0.47, 1.05]) for the LSAS-
SR were observed.
6. Health Economic Evaluation
6.1. Health Outcomes. Regarding symptom-free status, the
IMI signicantly diered from WLC on the SPS [incremen-
tal eect (ΔE=026; 95% CI, 0.150.37)] and on the SIAS
[incremental eect (ΔE=024; 95% CI, 0.140.34)]. On
average, the participants in the IMI gained 0.66 QALYs
(95% CI, 0.640.67) during follow-up, whereas the partici-
pants in the WLC gained 0.61 QALYs (95% CI, 0.590.62).
Statistically signicant dierences in the adjusted incremen-
tal QALYs were observed (ΔE=0046; 95% CI, 0.020.07).
6.2. Costs. At baseline, the mean total costs only diered (138;
US$183) moderately between the IMI (464, US$615) and the
WLC (603; US$800). Table 3 displays the average accumulated
costs over a 6-month period per participant by study arm. After
6 months, the total incremental costs were -211 in favor of the
intervention group (IMI, 850; WLC, 1061). The average
healthcare costs were higher in the IMI (345) compared with
the WLC (240). The patient and family costs were similar
in both groups slightly favoring the IMI. Productivity losses
especially presenteeism at work produced the highest cost
dierences of -227 (IMI, 391; WLC, 618) exceeding the
intervention costs.
6.3. Societal Perspective. Table 4 shows the incremental costs,
eects, and ICERs based on the 5000 bootstraps. The IMI
dominated the WLC related to the symptom-free status with
larger eects on the SPS and SIAS and less costs (SPS, -321,
95% CI [862, 66]; SIAS, -324, 95% CI [774, 125]). In the
cost-eectiveness plane, the majority of ICERs fell under the
southeast quadrant (Figure 2), reecting a 92% probability
that the intervention generates greater health eects at lower
costs than WLC (Figure 3).
The IMI generated small QALY gains at lower costs
(-319, 95% CI, 83164) compared with the WLC. From
a societal perspective, 93% of the simulated ICERs fell under
the southeast quadrant reecting the interventionsprobability
of dominating WLC (Figure 4). Assuming a WTP of 1000 for
QALY gains, the probability rose to 95% (Figure 5).
6.4. Healthcare Perspective. The bootstrapped ICER related
to the symptom-free status on the SPS and SIAS yielded an
ICER of 348 (95% CI, SPS [284,1069]; SIAS [304,
1043]), indicating that the IMI generated larger eects at
higher costs (SPS, 81; SIAS, 79) compared with the
WLC. Hence, the majority of ICERs fell under the northeast
quadrant (86%), while the probability of cost-eectiveness of
the intervention compared to WLC rose from 70/69% at a
WTP of 500 to 97% at a WTP of 1000 (Figures 6 and 7).
Regarding the cost utility, the IMI generated higher eects
per QALY gained at higher costs compared with WLC
(81; 95% CI, 105200). Thus, 86% of the simulated ICERs
fell in the northeast quadrant, showing higher QALY gains
and costs (Figure 8). At a WTP of 0, 2000, and 6000
for gaining one QALY, the probability rose from 14% to
54% to 96% (Figure 9).
6.5. Sensitivity Analyses. First, the study completers generated
signicant eects on all assessed outcomes and eect sizes at
least as large as in the ITT analysis (±d=01). Second,
Table 1: Results of the ANCOVAs and Cohensdfor the primary and secondary outcome measures (ITT sample) at 6-month follow-up
(T3).
Outcome T3 between-group eect T3 within-group eect T3 within-group eect
d(95%) F1,197 pIG WLC
Primary outcome
SPS 0.83 (0.54; 1.1) 55.01 <.001 1.27 (0.96; 1.57) 0.38 (0.10; 0.66)
SIAS 0.59 (0.30; 0.87) 49.03 <.001 1.30 (0.99; 1.60) 0.39 (0.11; 0.67)
Secondary Outcome
BDI-II 0.45 (0.17; 0.73) 7.21 <.001 0.59 (0.31; 0.87) 0.17 (-0.11; 0.44)
BSI 0.38 (0.10; 0.66) 7.41 <.001 0.52 (0.24; 0.81) 0.17 (0.11; 0.45)
LSAS 0.76 (0.47; 1.05) 54.92 <.001 1.30 (1.00; 1.61) 0.37 (0.09; 0.65)
IIP-64 0.60 (0.32; 0.89) 44.92 <.001 1.16 (0.86; 1.46) 0.32 (0.04; 0.60)
FPES 0.54 (0.26; 0.82) 40.22 <.001 0.94 (0.65; 1.23) -0.01 (-0.27; 0.29)
DPSOS-self 0.56 (0.82; 0.55) 21.43 <.001 0.68 (0.40; 0.97) -0.06 (-0.34; 0.22)
DPSOS-others 0.58 (0.30; 0.86) 31.27 <.001 0.80 (0.51; 1.09) -0.01 (-0.29; 0.27)
AQoL 0.23 (0.50; 0.05) 3.92 <0.01 0.66 (0.38; 0.95) 0.32 (0.04; 0.59)
EQ-5D -0.08 (-0.36; 0.20) 2.14 >0.05 0.14 (-0.14; 0.42) 0.15 (-0.13; 0.42)
The analysis of covariance with baseline levels as covariates (at T0) was used. ANCOVA: analysis of covariance; IG: intervention group; ITT: intention-to-
treat; M: means; SD: standard deviation; WLC: waitlist control group.
6 Depression and Anxiety
Table 2: Means and standard deviations for the IG and the WLC group (ITT sample).
Outcome
T0 T1
a
T2
a
IG WLC IG WLC IG WLC
MSDMSDMSDMSDMSDMSD
Primary outcome
SPS 34.36 11.79 35.71 13.54 21.03 11.54 30.63 13.72 19.48 11.61 30.32 14.38
SIAS 51.47 11.23 48.71 12.92 36.72 13.86 44.36 14.05 35.10 13.78 43.40 14.39
Secondary outcome
BDI-II 12.68 8.23 12.97 7.71 8.12 6.71 11.88 8.16 8.43 5.94 11.65 8.17
BSI 0.86 0.49 0.92 0.56 0.56 0.40 0.81 0.57 0.62 0.42 0.82 0.60
LSAS 77.61 16.87 76.96 19.57 58.82 20.45 72.51 22.17 52.08 21.87 69.10 22.64
IIP-64 1.71 0.39 1.66 0.43 1.34 0.47 1.5 0.48 1.17 0.53 1.5 0.56
FPES 43.82 11.00 39.90 13.00 36.17 13.49 39.95 14.6 33.19 11.54 40.06 13.62
DPSOS-self 16.76 4.91 15.85 5.68 14.35 5.42 16.06 5.89 13.47 4.69 16.16 4.89
DPSOS-others 42.51 11.93 40.16 12.56 36.11 14.81 40.60 14.81 32.27 13.59 40.31 14.03
AQoL 0.57 0.14 0.58 0.17 0.68 0.16 0.61 0.18 0.67 0.16 0.63 0.19
EQ5D 0.94 0.08 0.92 0.11 0.95 0.08 0.93 0.11 0.93 0.09 0.93 0.09
a
Missing data imputed by multiple imputation. IG: intervention group; ITT: intention-to-treat; M: means; SD: standard deviation; WLC: waitlist control
group.
Table 3: Average costs per participant (in ) by study arm at 6-month follow-up.
IG (n= 100) WLC (n= 100) Incremental costs
Mean (SD) () Mean (SD) ()Dierence ()
Intervention 178.50 —— +178.50
Healthcare costs
Physician services 18.90 (39.59) 38.06 (104.37) -19.16
Mental Healthcare 114.31 (294.02) 84.81 (215) +29.50
Inpatient care 0 (0) 21.97 (154.57) -21.97
a
Day care 0 (0) 47.42 (474.25) -47.42
Nonphysician services 12.58 (36.61) 24.93 (136.43) -12.35
Prescription drugs 21.70 (77.65) 23.11 (114.84) -1.40
167.49 (333.33) 240.31 (679.24) -72.82
Patient and family costs
Over-the-counter drugs 19.52 (36.08) 30.36 (64.13) -10.83
Opportunity costs 61.78 (131.52) 130.27 (364.33) -68.49
Travel expenses 8.67 (22.84) 19.10 (84.96) -10.42
Domestic help/informal care 22.97 (92.16) 23.46 (131.93) -0.49
112.95 (220.88) 203.19 (475.86) -90.24
Productivity losses
Absenteeism (work) 219.48 (405.15) 203.13 (568.15) +16.35
Presenteeism (work) 172.06 (331.87) 415.30 (1013.47) -243.24
391.54 (676.38) 618.43 (1466.64) -226.89
Total healthcare costs 345.99 (333.33) 240.31 (679.24) +105.69
Total societal costs 850.49 (943.42) 1061.94 (1969.21)) -211.45
b
Sensitivity analyses
Absenteeism (studies) 500.69 (591.80) 723.52 (1057.56) -222.83
Presenteeism (studies) 320.84 (354.25) 348.88 (476.02) -28.04
821.53 (789.47) 1072.40 (1370.93) -250.87
Average costs per participant are based on the area-under-the-curve approach and an intention-to-treat sample (N= 200).
a
Costs included one outlier that
was handled using winsorization.
b
Due to rounding, numbers may not add exactly to the totals provided. IG: intervention group; WLC: waitlist control group.
7Depression and Anxiety
Table 4: Results of the main and sensitivity analysis based on 5000 bootstrap simulations.
Outcome Incremental costs
() (95% CI)
Incremental eects
(points) (95% CI)
ICER (/points)
(95% CI)
Distribution over the
CE plane (%) WTP (p)
NE
b
SE
c
SW
d
NW
e
Main analysis
Societal perspective
Symptom-free status SPS (range: 0-1) -321 (-862 to 66) 0.26 (0.15 to 0.37)∗∗ Dominant (to 414) 8 92 —— 0 (0.92); 500 (0.98); 1000 (1)
Symptom-free status SIAS (range: 0-1) -324 (-774 to 125) 0.24 (0.14 to 0.34)∗∗ Dominant(to 415) 8 92 —— 0 (0.92); 500 (0.98); 1000 (1)
AQoL QALYs (range: 0-1) -319 (-831 to 64) 0.046∗∗ (0.024 to 0.68) Dominant (to 2447) 7 93 —— 0 (0.93); 1000 (0.95); 2000 (0.97);
3000 (0.98); 10,000 (1)
Healthcare perspective Symptom-free status SPS (range: 0-1) 81 (-105 to 200) 0.255 (0.144 to 0.366)∗∗ 348 (-284 to 1069) 86 14 —— 0 (0.14); 500 (0.70); 1000 (0.97);
2000 (1)
Symptom-free status SIAS (range: 0-1) 79 (-109 to 198) 0.244 (0.14 to 0.34)∗∗ 348 (-304 to 1043) 86 14 —— 0 (0.14); 500 (0.69); 1000 (0.97);
2000 (1)
AQoL QALYs (range: 0-1) 81 (-105 to 200) 0.046 (0.024 to 0.68)∗∗ 1945(-1521 to 6631) 86 14 —— 0 (0.14); 1000 (0.32); 2000 (0.54);
3000 (0.73); 6000 (0.96)
Sensitivity analyses ——
Diagnostic status
Societal Diagnostic status (range: 0-1) -323 (-860 to 64) 0.3 (0.16 to 0.43)∗∗ Dominant (to 332) 8 92 —— 0 (0.92); 500 (0.99); 1000 (1)
Healthcare Diagnostic status (range: 0-1) 79 (-107 to 198) 0.3 (0.16 to 0.43)∗∗ 288 (-254 to 900) 14 86 0 (0.14); 500 (0.79); 1000 (0.98)
EQ-5D
Societal QALYs (range: 0-1) -319 (-829 to 63) -0.00049 (-0.0166 to 0.0174) 112,106
a
5 48 45 2 0 (0.99); 10,000 (0.89); 100,000 (0.60)
Healthcare QALYs (range: 0-1) 80 (-100 to 210) -0.00059 (-0.016 to 0.015) Non-dominant 39 9 7 45 0 (0.15); 10,000 (0.26); 100,000 (0.48)
Increased intervention costs
+50% intervention costs
QALYs (range: 0-1) (societal) -230 (-741 to 153) 0.046 (0.024 to 0.68) Dominant (to 4859) 15 85 —— 0 (0.84); 1000 (0.89); 2000 (0.92);
3000 (0.95); 10,000 (1)
QALYs (range: 0-1) (healthcare) 170 (-15 to 289) 0.046 (0.024 to 0.68)∗∗ 3995 (325 to 9878) 98 2 —— 0 (0.02); 1000 (0.06); 2000 (0.16);
3000 (0.34); 10,000 (0.98)
+100% intervention costs
QALYs (range: 0-1) (societal) -140 (-651 to 242) 0.046 (0.024 to 0.68) Dominant (to 7417) 28 72 —— 0 (0.72); 1000 (0.79); 2000 (0.84);
3000 (0.89); 10,000 (0.99)
QALYs (range: 0-1) (healthcare) 259(113 to 404) 0.046 (0.024 to 0.67)∗∗ 6045 (2001 to 13,346) 100 —— 0 (0.00); 1000 (0.0); 2000 (0.02);
3000 (0.9); 10,000 (0.92)
Costs are expressed in Euros (reference year: 2017). The SUREG model included signicant outcome predictors (predictors for costs were age and treatment experience; predictors for outcome eects were
baseline variables for each outcome).
a
The dependably accurate 95% condence interval for this distribution cannot be dened because there is no line through the origin that excludes alpha/2 of the
distribution.
b
The northeast quadrant of the CE plane, indicating that intervention is more eective and more costly.
c
The southeast quadrant of the CE plane, indicating that intervention is more eective
and less costly.
d
The northwest quadrant of the CE plane, indicating that intervention is less eective and more costly.
e
The southwest quadrant of the CE plane, indicating that intervention is less eective
and less costly. ∗∗p<0 05. CI: condence interval; ICER: incremental cost-eectiveness ratio; WTP: willingness to pay.
8 Depression and Anxiety
regarding the QALY gains, even increasing the invention costs
by 50% and 100% did not alter the interpretation of results
either from a societal or healthcare perspective, respectively
(Table 2). Third, excluding the Swiss students did not aect
the results of the CEA or the CUA analyses. Fourth, using the
EQ-5D-5L resulted in a slightly nonsignicant (t200 =065,
p=052) incremental QALY gain of the IMI (0.939 QALY,
SD 0.070) compared with the WLC (0.932 QALY, SD
0.865). The greater sensitivity of the AQoL instrument and
the potential ceiling eect of the EQ-5D instrument may
have led to the dierences between the AQoL QALYs
(>0.55) and the EQ-5D QALYs (>0.9). Nevertheless, for
gaining a QALY at a WTP of 0/10,000, the probability
of cost-eectiveness was similar (99%/89%) from a societal
perspective and lower (15%/26%) from a healthcare perspec-
tive compared with the AQoL QALYs. Fifth, using the diag-
nostic status for the health economic evaluation yielded
similar results to the symptom-free status (Table 4).
7. Discussion
7.1. Principal Findings. This study is the rst to evaluate the
long-term ecacy and the cost-eectiveness of an unguided
IMI for university students with SAD compared with a wait-
list control condition (WLC) with unrestricted access to
treatment as usual over 6 months from a societal and public
healthcare perspective. The IMI maintained a signicant and
favorable eect on social phobia symptoms with moderate to
large eect sizes between groups at follow-up assessment (6
months; SPS, d=083; SIAS, d=059) compared with the
8%
92%
–1500
–1000
–500
0
500
1000
Incremental costs (euro)
−.2 −.1 .1 .2 .3 .4 .5
Incremental eects (symptom-free status)
Cost−eectiveness plane
Figure 2: Scatter plot showing the mean dierences in costs and eect outcome (symptom-free status, SPS) data using 5000 bootstrap
replications from a societal perspective.
0
.1
.2
.3
.4
.5
.6
.7
.8
.9
1
% Probability of cost−eectiveness
0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000
Willingness to pay
Figure 3: Cost-eectiveness acceptability curve showing the probability of the IMI being cost-eective at varying WTP ceilings (based on
5000 replicates of the ICER using mean dierences in costs and symptom-free status based on SPS) from a societal perspective.
9Depression and Anxiety
WLC. The IMI generated slightly lower costs (-321; 95%
CI, 86266), more QALYs (0.046; 95% CI, 0.0240.68),
and symptom-free status (SPS = 0 26; 95% CI, 0.150.37)
compared with the WLC in the long term. From a societal
perspective, the IMI dominated the WLC, while from a
healthcare perspective, the probability for cost-eectiveness
was 96% at a WTP of 6000 (US$7956) per symptom-free
status and QALY. Our ndings were robust to sensitivity
analyses.
7.2. Comparison with Prior Work. Our ndings are consis-
tent with the evidence on the ecacy of unguided IMIs in
the general population suering from SAD in the long term
[19]. A study (N=81) compared an unguided IMI with two
types of guided self-help after 6 months [36] and found
within-group eects (d1 5) similar to our study, but no
signicant eect was observed between the groups. Likewise,
smaller but also persistent eects (d=02) of an unguided
IMI were found when compared with WLC after one
year [29].
Regarding the university students, our ndings support
the existing evidence for internet-based interventions target-
ing SAD showing similar results as the previous studies [24]
(some focusing on fear of public speaking [23, 25]). Further-
more, these studies are characterized by a substantial drop-
out rate at posttreatment [24] (40%) or follow-up [25]
(67%) and did not assess the long-term ecacy of the
intervention.
7%
93%
−1500
−1000
−500
0
500
Incremental costs (euro)
−.04 −.02 0 .02 .04 .06 .08 .1
Incremental eects (QALY)
Cost−eectiveness plane
Figure 4: Scatter plot showing the mean dierences in costs and eect outcome (AQoL QALY) data using 5000 bootstrap replications from
a societal perspective.
0
.1
.2
.3
.4
.5
.6
.7
.8
.9
1
% probability of cost−eectiveness
0 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000
Willingness to pay
Figure 5: Cost-eectiveness acceptability curve showing the probability of the IMI being cost-eective at varying WTP ceilings [based on
5000 replicates of the incremental cost-eectiveness ratio (ICER) using mean dierences in costs and QALYs] from a societal perspective.
10 Depression and Anxiety
Likewise, further research is needed to conrm the eco-
nomic benets of IMIs for SAD. Results from our trial add
to the converging evidence pointing to their cost-
eectiveness. Four studies reported on health economic out-
comes of IMIs in SAD [2629]. Three studies found that
guided IMIs might be a cost-eective approach compared
with an active control over a period of 6 months and 4 years
from a societal and provider perspective, respectively. Show-
ing similar results to our study, one guided IMI generated
less costs and better treatment outcomes. At a WTP of 0
Euro, this IMI showed an 81% probability of cost-
eectiveness at 6 months [25] and a 61% probability at a
4-year follow-up [27]. Another guided IMI compared with
face-to-face treatment was judged as cost-eective, only
including cost for therapist time [27].
To our knowledge, only one health economic evaluation
has compared unguided IMI and passive control [29], which
indicated that the intervention is likely to be cost-eective.
The study diers from the present study in terms of the gen-
eral population, higher average age, dierent inclusion cri-
teria (also subclinical participants), and instruments used
(SF-6D versus AQoL). The IMI generated higher costs and
better eects at 6 months and dominated the control condi-
tion after 12 months. Compared with our study, this trial
focused on a nonclinical sample and had a substantial drop-
out rate (50%) which could lead to selection bias by attrition.
86%
14%
−500
0
500
Incremental costs (euro)
−.2 −.1 .1 .2 .3 .4 .5
Incremental eects (symptom−free status)
Cost−eectiveness plane
Figure 6: Scatter plot showing the mean dierences in costs and eect outcome (symptom-free status, SPS) data using 5000 bootstrap
replications from a healthcare perspective.
0
.1
.2
.3
.4
.5
.6
.7
.8
.9
1
% probability of cost−eectiveness
0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000
Willingness to pay
Figure 7: Cost-eectiveness acceptability curve showing the probability of the IMI being cost-eective at varying WTP ceilings (based on
5000 replicates of the ICER using mean dierences in costs and symptom-free status based on SPS) from a healthcare perspective.
11Depression and Anxiety
7.3. Strengths and Limitations. This study has several
strengths and limitations. The data in our trial was based on
self-report measures and diagnostic interviews, thereby
increasing the robustness of the results while minimizing bias
accompanying self-reported data due to recall period or selec-
tive recall. Evidence-based assessment consisting of more than
one assessment technique is recommended for accurate
assessment and eective treatment of anxiety disorders [81].
Additionally, our study only showed a relatively small number
of dropouts (22.5%) at 6-month follow-up compared with
most unguided studies [82]. This could be due to our struc-
tured research process (e.g., diagnostic interviews) and the
highly educated and technologically sophisticated group of
participants. Moreover, the characteristics of the study groups
were well balanced at baseline, and the proportion of female
participants (62%) was relatively low compared with most
IMIs also reecting the distribution of SAD in the population.
A further strength of our study is the inclusion of a full eco-
nomic evaluation. Notably, the economic ndings were con-
sistent across various sensitivity analyses.
86%
14%
−500
0
500
Incremental costs (euro)
−.02 0 .02 .04 .06 .08 .1
Incremental eects (QALY)
Cost−eectiveness plane
Figure 8: Scatter plot showing the mean dierences in costs and eect outcome (AQoL QALY) data using 5000 bootstrap replications from
a healthcare perspective.
0
.1
.2
.3
.4
.5
.6
.7
.8
.9
1
% probability of cost−eectiveness
0 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000 11000 12000
Willingness to pay
Figure 9: Cost-eectiveness acceptability curve showing the probability of the IMI being cost-eective at varying WTP ceilings [based on
5000 replicates of the incremental cost-eectiveness ratio (ICER) using mean dierences in costs and QALYs] from a healthcare perspective.
12 Depression and Anxiety
However, several limitations were noted. First, the time
horizon of our study was limited to 6 months. Costs due to
present and future underachievement, prolonged studies,
and study dropouts resulting in lower academic qualica-
tions could not be captured nor included in our evaluations
and may even increase the impact of the intervention. Sec-
ond, most instruments used self-report measures, which
might have led to social desirabilityand recall bias.
Third, there are several possible reasons why our study gen-
erated relatively high eect sizes compared to other IMIs tar-
geting SAD. Signicant structuring and research attention,
e.g., before and after the intervention via diagnostic inter-
views, could have led to the overestimation of eects com-
pared with interventions in routine care due to the
Hawthorne eect [83]. Additionally, participants were char-
acterized by high symptom severity at baseline assessment
giving them more room for improvement compared to sam-
ples with subclinical symptoms. Adherence and motivation
were increased by automated reminders and telephone
reminders for questionnaire completion. Fourth, our nd-
ings can be generalized to similar settings. Thus, our results
may be applicable to university students in Western coun-
tries with similar study characteristics. Finally, in health eco-
nomic evaluations [84], a standard care comparator (e.g.,
face-to-face CBT) is recommended rather than a waitlist
control group to avoid potential nocebo eects [85].
7.4. Clinical Implications and Future Research. The study
results support the idea that IMIs could be a low-threshold,
eective, and aordable way to reduce the adverse eects of
social anxiety disorder. The advantage of an IMI is that com-
pared with standard therapies, the marginal cost decreases
when extending coverage or increasing the uptake of the
intervention [86]. Low marginal costs and the scalability of
IMIs enable them to be used as public health tools to gener-
ate eects at the population level compared with guided or
face-to-face treatments that are not as scalable.
Moreover, based on the nature of social anxiety disorder,
patients tend to avoid face-to-face contact with the therapist
for fear being negatively evaluated. IMIs oer a low-
threshold approach to help those aected without using
face-to-face (F2F) treatments. This preference may also
increase the use of unguided approaches compared with
standard therapies. Therefore, future research should evalu-
ate head-to-head comparisons of self-help IMIs with guided
IMIs and F2F treatments.
Furthermore, in our study, only students who met the
diagnostic criteria were included. Nevertheless, the students
who were interested in participating but showing subclinical
symptoms of SAD increased threefold. Thus, further research
is needed to investigate the preventive eect of this IMI in stu-
dents at risk of developing SAD. The application of this IMI
across the range of mild to severe symptoms of SAD may bet-
ter t the requirements of a student mental health service at a
university. However, under uncontrolled naturalistic condi-
tions, the lack of research attention and reminders may
decrease the eectiveness of unguided IMIs. Implementation
studies could further examine the uptake and eectiveness of
unguided IMIs under routine care conditions.
The German SAD treatment guidelines [87] recommend
IMIs based on cognitive-behavioral therapy to bridge the
waiting times or accompanying face-to-face treatment.
Moreover, the results of our study add to the emerging evi-
dence base in support of recommending IMIs as a viable
treatment option in clinical guidelines. An ocial recogni-
tion of IMIs as a treatment option for SAD would help
bridge the current treatment gap. During the COVID-19
pandemic, the barriers of treatment utilization increased
and SAD symptoms in students were maintained due to
minimal social contact and isolation [88]. Untreated persons
generate long-term costs caused by persistent social anxiety
symptoms, such as low academic performance, subsequent
study dropouts, and worse job prospects, which are not
included in our health economic evaluation. For the future,
larger studies with longer follow-up periods are needed to
investigate the full extent of SAD from a cost viewpoint.
8. Conclusion
This study strengthens the existing evidence conrming that
internet-based self-help interventions for SAD can generate
and sustain a signicant and favorable eect in reducing
social anxiety symptoms in a cost-eective way. Given the
positive eects of the intervention, the implementation of
this IMI as part of a students healthcare management at
the university would be essential.
Data Availability
The datasets generated and/or analyzed during the current
study are available from the corresponding author on rea-
sonable request.
Additional Points
Key Points. (i) Unguided internet- and mobile-based inter-
ventions can induce and maintain favorable eects in stu-
dents with social anxiety disorder over a period of 6
months. (ii) The mobile interventions have an acceptable
likelihood of cost-eectiveness. (iii) It would be helpful to
integrate such mobile interventions into routine mental
healthcare at universities.
Disclosure
The funders did not have a role in the study design, data col-
lection, analysis and interpretation of the results, or the deci-
sion to publicize the study results.
Conflicts of Interest
DDE has served as a consultant to/on the scientic advisory
boards of Sano, Novartis, Minddistrict, Lantern, Schoen
Kliniken, Ideamed, German health insurance companies
(BARMER and Techniker Krankenkasse), and a number of
federal chambers for psychotherapy. He is also a stakeholder
in the Institute for Health Training Online (formerly
GET.ON, now HelloBetter), which is aimed at implementing
scienticndings related to digital health interventions into
13Depression and Anxiety
routine care. HB received consultancy fees, reimbursement
of congress attendance, and travel costs as well as payments
for lectures from psychotherapy, psychiatry, and further
medical associations, institutes, clinics, and companies in
the context of e-mental-health topics. He sublicensed a dig-
ital intervention to a company providing digital health inter-
ventions. He has been the beneciary of study support
(third-party funding) from several public funding organiza-
tions. The other authors, CB, FK, FS, and TB, declare no
competing interest.
AuthorsContributions
FK, DDE, and TB have contributed to the study design. FK
drafted the manuscript. CB and FS contributed to the analy-
sis and interpretation of the data. CB, DDE, FS, HB, and TB
critically revised the content. All authors read and approved
the nal manuscript.
Acknowledgments
The authors would like to thank all participants, research
assistants such as Julia Burger, Mirjam Thomas, therapists,
and all others who contributed to our study. Funding was
received from BARMER GEK (German statutory health
insurance company). DDE and HB obtained the funding
for this trial. Open access funding was enabled and orga-
nized by Projekt DEAL.
Supplementary Materials
Table S1: unit costs for the type of health service utilized by
the participants. Table S2: baseline sample characteristics.
Table S3: treatment response, symptom-free status, and
symptom deterioration at 6-month follow-up.
(Supplementary Materials)
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Background: Many people are accessing digital self-help for mental health problems, often with little evidence of effectiveness. Social anxiety is one of the most common sources of mental distress in the population and many people with symptoms do not seek help for what represents a significant public health problem. Objective: Two group randomized controlled trial conducted in England between 11th May 2016 and 27th June 2018. Adults with social anxiety symptoms who were not receiving treatment for social anxiety were recruited using online advertisements. All participants had unrestricted access to usual care and were randomized in a 1:1 ratio to either a web-based unguided self-help intervention based on cognitive-behavioural principles, or to a waiting list control group. All outcomes were collected through self-report online questionnaires. The primary outcome was the change in 17-item self-report Social Phobia Inventory (SPIN-17) score from baseline to 6 weeks using a linear mixed-effect model that used data from all timepoints (6 weeks, 3, 6, 12 months). Methods: Two group randomized controlled trial conducted in England between 11th May 2016 and 27th June 2018. Adults with social anxiety symptoms who were not receiving treatment for social anxiety were recruited using online advertisements. All participants had unrestricted access to usual care and were randomized in a 1:1 ratio to either a web-based unguided self-help intervention based on cognitive-behavioural principles, or to a waiting list control group. All outcomes were collected through self-report online questionnaires. The primary outcome was the change in 17-item self-report Social Phobia Inventory (SPIN-17) score from baseline to 6 weeks using a linear mixed-effect model that used data from all timepoints (6 weeks, 3, 6, 12 months). Results: 2212 participants were randomized. Six were excluded from analyses as ineligible. Of the 2116 eligible randomized participants (mean age 37 years, 80% women), 70.1% (1484/2116) had follow-up data available for analysis, and 56.9% (1205/2116) had data on the primary outcome, although attrition was higher in the intervention arm. At 6 weeks the mean (95% CI, P value) adjusted difference in change in SPIN-17 score in the intervention group compared to control, was -1.94 (-3.13 to -0.75, P=0.0014), a standardised mean difference effect size of 0.2. The improvement was maintained at 12 months. Given the high drop-out, sensitivity analyses explored missing data assumptions and were consistent with the primary analysis finding. The economic evaluation demonstrated cost-effectiveness with a small health status benefit and a reduction in health service utilisation. Conclusions: For people with social anxiety symptoms who are not receiving other forms of help, this study suggests that an online self-help tool based on cognitive behavioural principles can provide a small improvement in social anxiety symptoms compared with no intervention, although drop-out rates were high. Clinicaltrial: ClinicalTrials.gov NCT02451878. https://clinicaltrials.gov/ct2/show/NCT02451878.
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Background: Social anxiety disorder (SAD) is highly prevalent among university students, but the majority of affected students remain untreated. Internet- and mobile-based self-help interventions (IMIs) may be a promising strategy to address this unmet need. This study aims to investigate the efficacy and cost-effectiveness of an unguided internet-based treatment for SAD among university students. The intervention is optimized for the treatment of university students and includes one module targeting fear of positive evaluations that is a neglected aspect of SAD treatment. Methods: The study is a two arm randomized controlled trial in which 200 university students with a primary diagnosis of SAD will be assigned randomly to either a wait-list control group (WLC) or the intervention group (IG). The intervention consists of 9 sessions of an internet-based cognitive-behavioral treatment, which also includes a module on fear of positive evaluation (FPE). Guidance is delivered only on the basis of standardized automatic messages, consisting of positive reinforcements for session completion, reminders, and motivational messages in response to non-adherence. All participants will additionally have full access to treatment as usual. Diagnostic status will be assessed through Structured Clinical Interviews for DSM Disorders (SCID). Assessments will be completed at baseline, 10 weeks and 6-month follow-up. The primary outcome will be SAD symptoms at post-treatment, assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). Secondary outcomes will include diagnostic status, depression, quality of life and fear of positive evaluation. Cost-effectiveness and cost-utility analyses will be evaluated from a societal and health provider perspective. Discussion: Results of this study will contribute to growing evidence for the efficacy and cost-effectiveness of unguided IMIs for the treatment of SAD in university students. Consequently, this trial may provide valuable information for policy makers and clinicians regarding the allocation of limited treatment resources to such interventions. Trial registration: DRKS00011424 (German Clinical Trials Register (DRKS)) Registered 14/12/2016.
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Background Although mental disorders and suicidal thoughts‐behaviors (suicidal thoughts and behaviors) are common among university students, the majority of students with these problems remain untreated. It is unclear what the barriers are to these students seeking treatment. Aims The aim of this study is to examine the barriers to future help‐seeking and the associations of clinical characteristics with these barriers in a cross‐national sample of first‐year college students. Method As part of the World Mental Health International College Student (WMH‐ICS) initiative, web‐based self‐report surveys were obtained from 13,984 first‐year students in eight countries across the world. Clinical characteristics examined included screens for common mental disorders and reports about suicidal thoughts and behaviors. Multivariate regression models adjusted for socio‐demographic, college‐, and treatment‐related variables were used to examine correlates of help‐seeking intention and barriers to seeking treatment. Results Only 24.6% of students reported that they would definitely seek treatment if they had a future emotional problem. The most commonly reported reasons not to seek treatment among students who failed to report that they would definitely seek help were the preference to handle the problem alone (56.4%) and wanting to talk with friends or relatives instead (48.0%). Preference to handle the problem alone and feeling too embarrassed were also associated with significantly reduced odds of having at least some intention to seek help among students who failed to report that they would definitely seek help. Having 12‐month major depression, alcohol use disorder, and suicidal thoughts and behaviors were also associated with significantly reduced reported odds of the latter outcome. Conclusions The majority of first‐year college students in the WMH‐ICS surveys report that they would be hesitant to seek help in case of future emotional problems. Attitudinal barriers and not structural barriers were found to be the most important reported reasons for this hesitation. Experimental research is needed to determine whether intention to seek help and, more importantly, actual help‐seeking behavior could be increased with the extent to which intervention strategies need to be tailored to particular student characteristics. Given that the preference to handle problems alone and stigma and appear to be critical, there could be value in determining if internet‐based psychological treatments, which can be accessed privately and are often build as self‐help approaches, would be more acceptable than other types of treatments to student who report hesitation about seeking treatment.
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Praise for the First Edition of Statistical Analysis with Missing Data “An important contribution to the applied statistics literature.... I give the book high marks for unifying and making accessible much of the past and current work in this important area.”—William E. Strawderman, Rutgers University “This book...provide[s] interesting real-life examples, stimulating end-of-chapter exercises, and up-to-date references. It should be on every applied statistician’s bookshelf.”—The Statistician “The book should be studied in the statistical methods department in every statistical agency.”—Journal of Official Statistics Statistical analysis of data sets with missing values is a pervasive problem for which standard methods are of limited value. The first edition of Statistical Analysis with Missing Data has been a standard reference on missing-data methods. Now, reflecting extensive developments in Bayesian methods for simulating posterior distributions, this Second Edition by two acknowledged experts on the subject offers a thoroughly up-to-date, reorganized survey of current methodology for handling missing-data problems. Blending theory and application, authors Roderick Little and Donald Rubin review historical approaches to the subject and describe rigorous yet simple methods for multivariate analysis with missing values. They then provide a coherent theory for analysis of problems based on likelihoods derived from statistical models for the data and the missing-data mechanism and apply the theory to a wide range of important missing-data problems. The new edition now enlarges its coverage to include: Expanded coverage of Bayesian methodology, both theoretical and computational, and of multiple imputation Analysis of data with missing values where inferences are based on likelihoods derived from formal statistical models for the data-generating and missing-data mechanisms Applications of the approach in a variety of contexts including regression, factor analysis, contingency table analysis, time series, and sample survey inference Extensive references, examples, and exercises Amstat News asked three review editors to rate their top five favorite books in the September 2003 issue. Statistical Analysis With Missing Data was among those chosen.
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