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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 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=059; 95% CI, 0.30, 0.87) and SPS (Cohen’sd=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-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.
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 18–35 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 effects 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 qualification [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 flexible, accessible, and anonymous [16–18], present a
promising approach to reach those affected individuals.
Unguided IMIs have received adequate attention owing to
their potential for high scalability and relatively low mar-
ginal costs. The efficacy of unguided IMIs based on
cognitive-behavioral approaches targeting SAD has been
shown with medium effects at posttreatment compared with
that of passive controls (g=078, 95% CI [0.50–1.05], SE
=014,p<0001,k=5). However, in contrast to guided
IMIs, the evidence for the long-term efficacy of unguided
IMIs is still limited [19–22].
Moreover, the value of IMIs for SAD in university stu-
dents has not been sufficiently investigated. Existing evi-
dence suggests that IMIs targeting SAD in university
students might have beneficial effects up to one year with
or without guidance [23–25]. 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 efficacy of IMIs for SAD, evidence to
support their cost-effectiveness is still insufficient. While
the assessment of the efficacy takes the benefits for patients
into account, the assessment of economic consequences also
considers a wider perspective by providing insights into soci-
etal costs and benefits. Only three studies investigated the
economic merits of IMIs for SAD, indicating that guided
[26–28] and unguided [29] IMIs may be a cost-effective
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 effect sizes
[30]. In this study, we report its clinical effects 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-effectiveness 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); identification and modification 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 5–7); healthy lifestyle and problem-solving skills
2 Depression and Anxiety
(Session 8); and relapse prevention (Session 9). The focus
on FPE reflected 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 all”to 4 = “extremely”). These two scales have
been found to be valid, reliable, and useful for clinical and
research purposes [39]. Cronbach’sαfor 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-offvalues to differentiate 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 different situations) [42] (Cronbach’sα
=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], Disqualification 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-
bach’sαof 0.96. The EQ-5D-5L is a widely applied, valid,
and reliable measurement of QoL [52]. It consists of five
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-specific 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
intervention’s market price was estimated at €150
(US$198.89) per participant, reflecting 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 student’s monthly salary. Presenteeism was
determined based on an inefficiency score (Osterhaus
method [63]) multiplied by the number of working days
affected. Then, costs of presenteeism were calculated based
on the student’s 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 difference 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. Cohen’sdwith 95% CIs was calculated.
Treatment response and clinically significant deteriora-
tion were defined by the Reliable Change Index [38]. The
participants were defined 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].
Differences 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-
fied 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 identified 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 effects was applied because the
follow-up period did not exceed one year. The incremental
cost-effectiveness ratio (ICER) displays the incremental costs
per unit of the effect (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 reflected 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 significance. A 5000-fold bootstrapped seemingly
unrelated regression equation model on costs and effects
was used to generate the incremental costs and effects, while
adjusting for baseline utilities, age, and prior psychotherapy
[78]. The 5000 bootstrap replications of cost-and-effect pairs
were used to obtain 95% confidence intervals and plotted in
a cost-effectiveness plane. The plane depicts the incremental
effects between the intervention and control group on the x
-axis and the incremental costs between the groups on the y
-axis. The intervention “dominates”the control groups if
better effects 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
“inferior”to the control group as higher costs are associated
with worse health outcomes. Thus, it is not considered cost-
effective [62]. In the southwest quadrant, an intervention is
less effective and less costly than the control group. On the
other hand, in the northeast quadrant, an intervention is
more effective 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-effectiveness accept-
ability curve was displayed that indicates the probability of
cost-effectiveness 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 findings. Their number and employment
rate were balanced across groups, but differences 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 effect outcome for policymakers
was used for the cost-effectiveness 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 flow can be found elsewhere
[31]. We did not observe any clinically relevant baseline
differences between the study conditions. The dropout rates
between IMI (n= 32/100,32%)andWLC(n= 13/100, 13%)
differed significantly (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 differences were sta-
tistically significant: SPS, F1, 197 =5501,p<0001; SIAS,
F1, 197 =4903,p<0001. The corresponding standard-
ized effect 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 (Cohen’skappa,κ=078 [80]).
5.3. Treatment Response, Symptom-Free Status, and
Symptom Deterioration. After 6 months, significantly 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 significant 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. Significant between-
group differences for all outcomes, except the EQ-5D, with
effect 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 significantly differed from WLC on the SPS [incremen-
tal effect (ΔE=026; 95% CI, 0.15–0.37)] and on the SIAS
[incremental effect (ΔE=024; 95% CI, 0.14–0.34)]. On
average, the participants in the IMI gained 0.66 QALYs
(95% CI, 0.64–0.67) during follow-up, whereas the partici-
pants in the WLC gained 0.61 QALYs (95% CI, 0.59–0.62).
Statistically significant differences in the adjusted incremen-
tal QALYs were observed (ΔE=0046; 95% CI, 0.02–0.07).
6.2. Costs. At baseline, the mean total costs only differed (€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
differences of -€227 (IMI, €391; WLC, €618) exceeding the
intervention costs.
6.3. Societal Perspective. Table 4 shows the incremental costs,
effects, and ICERs based on the 5000 bootstraps. The IMI
dominated the WLC related to the symptom-free status with
larger effects on the SPS and SIAS and less costs (SPS, -€321,
95% CI [−862, 66]; SIAS, -€324, 95% CI [−774, 125]). In the
cost-effectiveness plane, the majority of ICERs fell under the
southeast quadrant (Figure 2), reflecting a 92% probability
that the intervention generates greater health effects at lower
costs than WLC (Figure 3).
The IMI generated small QALY gains at lower costs
(-€319, 95% CI, −831–64) compared with the WLC. From
a societal perspective, 93% of the simulated ICERs fell under
the southeast quadrant reflecting the intervention’sprobability
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 effects 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-effectiveness 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 effects
per QALY gained at higher costs compared with WLC
(€81; 95% CI, 105–200). 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
significant effects on all assessed outcomes and effect sizes at
least as large as in the ITT analysis (±d=01). Second,
Table 1: Results of the ANCOVAs and Cohen’sdfor the primary and secondary outcome measures (ITT sample) at 6-month follow-up
(T3).
Outcome T3 between-group effect T3 within-group effect T3 within-group effect
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) (€)Difference (€)
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 effects
(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 significant outcome predictors (predictors for costs were age and treatment experience; predictors for outcome effects were
baseline variables for each outcome).
a
The dependably accurate 95% confidence interval for this distribution cannot be defined 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 effective and more costly.
c
The southeast quadrant of the CE plane, indicating that intervention is more effective
and less costly.
d
The northwest quadrant of the CE plane, indicating that intervention is less effective and more costly.
e
The southwest quadrant of the CE plane, indicating that intervention is less effective
and less costly. ∗∗p<0 05. CI: confidence interval; ICER: incremental cost-effectiveness 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 affect
the results of the CEA or the CUA analyses. Fourth, using the
EQ-5D-5L resulted in a slightly nonsignificant (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 effect of the EQ-5D instrument may
have led to the differences 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-effectiveness 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 first to evaluate the
long-term efficacy and the cost-effectiveness 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 significant and
favorable effect on social phobia symptoms with moderate to
large effect 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 eects (symptom-free status)
Cost−eectiveness plane
Figure 2: Scatter plot showing the mean differences in costs and effect 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−eectiveness
0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000
Willingness to pay
Figure 3: Cost-effectiveness acceptability curve showing the probability of the IMI being cost-effective at varying WTP ceilings (based on
5000 replicates of the ICER using mean differences 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, −862–66), more QALYs (0.046; 95% CI, 0.024–0.68),
and symptom-free status (SPS = 0 26; 95% CI, 0.15–0.37)
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-effectiveness
was 96% at a WTP of €6000 (US$7956) per symptom-free
status and QALY. Our findings were robust to sensitivity
analyses.
7.2. Comparison with Prior Work. Our findings are consis-
tent with the evidence on the efficacy of unguided IMIs in
the general population suffering 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 effects (d≈1 5) similar to our study, but no
significant effect was observed between the groups. Likewise,
smaller but also persistent effects (d=02) of an unguided
IMI were found when compared with WLC after one
year [29].
Regarding the university students, our findings 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 efficacy of the
intervention.
7%
93%
−1500
−1000
−500
0
500
Incremental costs (euro)
−.04 −.02 0 .02 .04 .06 .08 .1
Incremental eects (QALY)
Cost−eectiveness plane
Figure 4: Scatter plot showing the mean differences in costs and effect 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−eectiveness
0 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000
Willingness to pay
Figure 5: Cost-effectiveness acceptability curve showing the probability of the IMI being cost-effective at varying WTP ceilings [based on
5000 replicates of the incremental cost-effectiveness ratio (ICER) using mean differences in costs and QALYs] from a societal perspective.
10 Depression and Anxiety
Likewise, further research is needed to confirm the eco-
nomic benefits of IMIs for SAD. Results from our trial add
to the converging evidence pointing to their cost-
effectiveness. Four studies reported on health economic out-
comes of IMIs in SAD [26–29]. Three studies found that
guided IMIs might be a cost-effective 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-
effectiveness 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-effective, 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-effective.
The study differs from the present study in terms of the gen-
eral population, higher average age, different inclusion cri-
teria (also subclinical participants), and instruments used
(SF-6D versus AQoL). The IMI generated higher costs and
better effects 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 eects (symptom−free status)
Cost−eectiveness plane
Figure 6: Scatter plot showing the mean differences in costs and effect 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−eectiveness
0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000
Willingness to pay
Figure 7: Cost-effectiveness acceptability curve showing the probability of the IMI being cost-effective at varying WTP ceilings (based on
5000 replicates of the ICER using mean differences 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 effective 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 reflecting 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 findings were con-
sistent across various sensitivity analyses.
86%
14%
−500
0
500
Incremental costs (euro)
−.02 0 .02 .04 .06 .08 .1
Incremental eects (QALY)
Cost−eectiveness plane
Figure 8: Scatter plot showing the mean differences in costs and effect 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−eectiveness
0 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000 11000 12000
Willingness to pay
Figure 9: Cost-effectiveness acceptability curve showing the probability of the IMI being cost-effective at varying WTP ceilings [based on
5000 replicates of the incremental cost-effectiveness ratio (ICER) using mean differences 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 qualifica-
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 desirability”and “recall bias.”
Third, there are several possible reasons why our study gen-
erated relatively high effect sizes compared to other IMIs tar-
geting SAD. Significant structuring and research attention,
e.g., before and after the intervention via diagnostic inter-
views, could have led to the overestimation of effects com-
pared with interventions in routine care due to the
Hawthorne effect [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 find-
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 effects [85].
7.4. Clinical Implications and Future Research. The study
results support the idea that IMIs could be a low-threshold,
effective, and affordable way to reduce the adverse effects 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 effects 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 offer a low-
threshold approach to help those affected 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 effect 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 fit 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 effectiveness of unguided IMIs. Implementation
studies could further examine the uptake and effectiveness 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 official 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 confirming that
internet-based self-help interventions for SAD can generate
and sustain a significant and favorable effect in reducing
social anxiety symptoms in a cost-effective way. Given the
positive effects of the intervention, the implementation of
this IMI as part of a student’s 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 effects in stu-
dents with social anxiety disorder over a period of 6
months. (ii) The mobile interventions have an acceptable
likelihood of cost-effectiveness. (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 scientific advisory
boards of Sanofi, 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
scientificfindings 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 beneficiary of study support
(third-party funding) from several public funding organiza-
tions. The other authors, CB, FK, FS, and TB, declare no
competing interest.
Authors’Contributions
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 final 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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