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delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
https://doi.org/10.1186/s12888‑022‑04132‑6
STUDY PROTOCOL
Ecacy ofatransdiagnostic guided
internet‑delivered intervention foremotional,
trauma andstress‑related disorders inMexican
population: study protocol forarandomized
controlled trial
Anabel de la Rosa‑Gómez1* , Lorena A. Flores‑Plata1 , Esteban E. Esquivel‑Santoveña2 ,
Carolina Santillán Torres Torija1 , Raquel García‑Flores3 , Alejandro Dominguez‑Rodriguez4 ,
Paulina Arenas‑Landgrave5 , Rosa O. Castellanos‑Vargas6 , Enrique Berra‑Ruiz7 , Rocío Silvestre‑Ramírez8 ,
Germán Alejandro Miranda‑Díaz1 , Dulce M. Díaz‑Sosa1 , Alejandrina Hernández‑Posadas1 ,
Alicia I. Flores‑Elvira1 , Pablo D. Valencia1 and Mario F. Vázquez‑Sánchez1
Abstract
Background: Emotional and stress‑related disorders show high incidence, prevalence, morbidity, and comorbidity
rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder‑
specific perspective, are the effective front‑line treatment for anxiety and depression care. However, these treatments
are not often used. Reasons include limited access and low availability to effective interventions and comorbidity
between mental disorders. Emotional deregulation of negative affectivity has been found to be a mediating factor
in addressing emotional disorders from a transdiagnostic perspective, aimed at two or more specific disorders. In
addition, technological advancement has created alternatives for psychological assistance, highlighting the pos‑
sibilities offered by technologies since Internet‑supported intervention programs have been empirically tested for
effectiveness, efficiency and efficacy and can be key to ensuring access to those who are inaccessible. The aim of the
study is to evaluate the efficacy, moderators of clinical change and acceptability of a transdiagnostic guided Internet‑
delivered intervention versus a transdiagnostic self‑guided Internet‑delivered intervention for emotional, trauma and
stress‑related disorders, and waiting list in community sample.
Methods: A three‑armed, parallel group, superiority randomized controlled clinical trial with repeated measure‑
ments at four times: pretest, posttest, follow‑up at 3, 6 and 12 months. Outcomes assessor, participant, care provider
and investigator will be blinded. Participants aged 18 to 70 years will be randomly allocated 1:1:1 to one of three
study arms: a) Transdiagnostic guided internet‑delivered intervention with synchronous assistance, b) Transdiagnostic
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Open Access
*Correspondence: anabel.dlr@gmail.com
1 Faculty of Higher Studies Iztacala, National Autonomous University
of Mexico, State of Mexico, Mexico
Full list of author information is available at the end of the article
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Page 2 of 12
delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
Background
Globally, mental disorders are a serious public health
problem with a high social cost that affects people
regardless of age, sex, socioeconomic status, or culture
[1]. In particular, Emotional Disorders (ED), defined as
anxiety and mood disorders (unipolar depression), have
been identified as the main causes of psychological dis-
ability [2], due to their high prevalence, morbidity and
comorbidity. In this regard, the Pan American Health
Organization (PAHO) revealed high prevalence esti-
mates for anxiety disorders (28.8%) and mood disorders
(20.8%), with comorbidity rates ranging from 40 to 80%
[3]. In Mexico, the last National Survey of Psychiatric
Epidemiology, in 2003 reported that among the most
common disorders of the population are those related to
anxiety (14.3%) [4]; while depression accounts for 4.3%
of the overall burden of mental disorders [3]. us, the
impact on the health of the general population, and in
particular the Mexican population, lies not only in sta-
tistics, but also in the emotional and economic conse-
quences when considering the detrimental effects in the
functioning of the person within the family, social and
labor spheres, limiting possibilities for personal develop-
ment and quality of life.
Individuals suffering from depression are more likely
to develop comorbidity with other mental disorders. An
estimated 53% have concurrent symptomatology with
some anxiety disorder [5]. Stress and traumatic events
are among the most relevant causes, between 60 and
80%, contributing to the etiology of EDs. Depression and
anxiety have also been deemed to create a condition of
greater disability by increasing the severity and chronic-
ity rate of psychological discomfort and is associated with
increased mortality in medical conditions such as heart
disease, chronic-degenerative or psychiatric conditions
[6]. In Mexico, one in four people between the age of 18
and 65 have experienced at some point in their lives an
ED, but only one in five of those with it receive treatment
and the time to receive care in a health center ranges
from four to 20years depending on the reason for con-
sultation [6].
In recent decades, cognitive behavioral interventions
(e.g., cognitive restructuring, exposure therapy, anxiety
management techniques, cognitive therapy), from a dis-
order-specific perspective, constitute an effective and
first-line treatment for anxiety and depression care [7,
8]. However, they are not often used [9] because of the
following reasons: limited access and low availability to
effective interventions, a minority of people actively seek
psychological care because of their own distress condi-
tion, fearing social stigma, geographical barriers that
separate them from health centers, time availability, pref-
erence for other treatment or self-help, high treatment
costs, which makes it inaccessible and unaffordable to
both, the user and the public health system [6]. It has also
been stated that the comorbidity between mental dis-
orders as well as the gap between research findings and
clinical practice could influence the poor dissemination
of effective treatments and contribute to a lack of up-to-
date professionals providing relevant interventions [10].
is has motivated studies aimed at knowing the mod-
erating, mediating variables and psychological mecha-
nisms that improve the process of clinical change [11]. In
addition, the need to implement innovative solutions that
contribute to the dissemination of effective treatments
for the care of EDs has been raised [8]. In particular,
emotional deregulation of negative affection is a factor
of interest in research that is providing relevant data for
better understanding and approaching EDs from a trans-
diagnostic perspective, a term coined from a dimensional
conception to designate effective treatments targeting
two or more specific disorders [12].
In this regard, Barlow returns to the tripartite theory
of emotion [13] and proposes a unified transdiagnostic
behavioral cognitive protocol for the treatment of EDs
with an emphasis on emotional regulation [14]. e Uni-
fied Protocol for the Treatment of Emotional Disorders
[UP] addresses four main components to decrease emo-
tional dysregulation: emotional avoidance, promotion of
cognitive flexibility, exposure to avoided situations and
sensations, and emotional awareness focused on the pre-
sent. UP has shown its effectiveness not only in achieving
the decrease in target symptomatology, but also increases
attendance at therapeutic sessions compared to conven-
tional psychological interventions [15]. In addition, some
meta-analyses have been performed which reveal the
self‑guided internet‑delivered intervention, c) Waiting list group. Based on sample size estimation, a minimum of 207
participants (69 in each intervention group) will be included.
Discussion: The study could contribute to improving the efficacy of transdiagnostic internet‑delivered interven‑
tions to promote the dissemination of evidence‑based treatments and eventually, to decrease the high prevalence of
emotional and trauma‑related disorders in the Mexican population.
Trial registration: ClinicalTrial.gov: NCT05 225701. Registered February 4, 2022.
Keywords: Emotional disorders, Trauma disorders, Transdiagnostic, Internet‑based intervention, Telepsychology
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delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
effectiveness of transdiagnostic protocols for anxiety dis-
orders [16], and for anxiety and/or depression [17].
In recent years there has been an increase in initia-
tives aimed at the promotion and intervention in mental
health mediated by technology that has favored access
and dissemination of effective interventions regardless
of distance, physical and social barriers [18]. Currently,
internet- delivered psychological interventions can
reduce the time of contact between patient and therapist
and reaching people who would not otherwise receive
treatment [19]. Evidence suggests that Internet-based
treatments are effective for the treatment of depres-
sion, anxiety, substance abuse and eating disorders [20].
In addition, meta-analysis data reveal that these inter-
ventions are as effective as face-to-face treatments [21].
Internet-delivered interventions can be classified into:
treatments administered by the therapist, treatments
with minimum assistance from the therapist, and fully
self-applied treatments [22].
In this sense, there is evidence of effective transdiag-
nostic internet-delivered interventions focusing on the
emotion enhance the scope and impact of psychological
treatment programs for emotional disorders [5, 23, 24].
However, there is incipient research into the efficiency of
transdiagnostic Cognitive Behavioral Treatments (CBT)
via the Internet for Trauma and Stress-related Disor-
ders. Some studies have documented the effectiveness
of computer-based interventions showing significant
changes in anxiety reduction, presenting moderate effect
sizes (g = 0.78) and large effect sizes in cases of depres-
sion (g = 0.84) [7, 25, 26]. Other studies that have inves-
tigated the efficacy of transdiagnostic CBT provided over
the Internet in cases with concurrent symptomatology
of anxiety and depression; have found moderate to large
effects for both depression and anxiety (anxiety: g = 0.82,
95% CI: 0.58 to 1.05; depression: g = 0.79; 95% CI: 0.59–
1.00) compared to control groups that included waiting
list. However, there are few controlled clinical studies
investigating the effects of transdiagnostic treatment via
the Internet for ED adapted to the Mexican context and
culture.
Evidence of the effectiveness of preventive and/or
remedial interventions over the Internet in the context
of public health for the reduction of the incidence of
depressive and anxious symptomatology is still low; the
latest systematic review identified seven uncontrolled
clinical studies that evaluated the effect of Internet-
mediated interventions with positive results [11]. How-
ever, only one clinical study aimed at preventing general
anxiety was found, and it did not produce significant
results [27], while three studies managed to reduce the
incidence of depression [28, 29]. In the study conducted
by Dear etal., the authors reported that the self-applied
Internet-guided intervention decreased depressive symp-
tomatology in a group of adults and managed to reduce
the risk of chronic depression by 39% per follow-up year
[29]. Recent research on the effectiveness of self-applied
interventions via the Internet with and without the sup-
port of a trained psychologist has indicated that fully
self-applied technology-mediated treatments show fewer
rates of improvement compared to those who did have
synchronous support with a therapist [30]. Other studies
that have researched the influence of support or guidance
during self-applied Internet-based interventions have
reported that participants who received weekly support
significantly improved in reducing depression compared
to a waiting list group, while participants who did not
receive support by a psychotherapist did not show signifi-
cant improvement [31]. However, some authors propose
that the differences in results obtained between guided
and non-guided interventions are small or non-existent
[32]. is aspect is relevant for assessing the efficiency
of interventions provided with technology, as they could
benefit more people who need it. In general, research
findings available in the literature are promising; how-
ever, it is also important to note that most studies have
been conducted in the Anglo-Saxon or Spanish popula-
tions. Hence it becomes necessary to know the results in
controlled studies in the Mexican context and culture and
with larger samples to reach stronger conclusions regard-
ing the effectiveness and efficiency of transdiagnostic
Internet-delivered interventions for the care of EDs.
In Mexico, research in this area is incipient, empha-
sizing the need to go beyond traditional face-to-face
interventions and to design new intervention strategies.
In this regard, the possibilities offered by technologies
are highlighted since Internet-supported intervention
programs have been empirically tested to achieve effec-
tiveness and efficiency/cost–benefit and can be key to
ensuring access to those who are inaccessible.
Finally, most of the research that has documented effi-
cacy of transdiagnostic treatments have excluded PTSD
from the research, a disorder which continues to be in
Mexico more and more prevalent, related to migration,
earthquakes, and violence [33]. Transdiagnostic inter-
ventions have been used on anxiety and now stress and
trauma disorders correspond to a new DSM5 category,
and as Gutber etal. [34] underlies, there is a need for tri-
als so we can understand how the transdiagnostic model
works with specific symptoms related to PTSD.
Aims
e primary aim of the study is to evaluate the efficacy
and acceptability of a transdiagnostic guided Internet-
delivered intervention versus a transdiagnostic self-
guided Internet-delivered intervention for emotional,
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delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
trauma and stress-related disorders, and a waiting list
in a Mexican community sample. e second aim is to
examine the moderator of clinical change, particularly
emotional regulation, in the transdiagnostic Internet-
delivered intervention for emotional, trauma and stress-
related disorders.
Hypothesis
– e transdiagnostic guided Internet-delivered inter-
vention will show statistical greater gains in reduc-
ing symptoms of anxiety/depression/acute or post-
traumatic stress and a more clinically significant
improvement compared to the transdiagnostic self-
guided Internet-delivered intervention and waiting
list groups.
– e transdiagnostic self-guided Internet-delivered
intervention will reduce symptoms of anxiety/
depression/acute or post-traumatic stress compared
to a waiting list group.
– A higher acceptance/satisfaction rate reported by
participants in transdiagnostic guided Internet-
delivered intervention will be found compared to the
transdiagnostic self-guided Internet-delivered inter-
vention.
– Emotional Regulation will be a moderating variable
for clinical change.
– Changes will be maintained three, six and 12months
after the end of the intervention program with and
without synchronous psychological support.
Methods
Study design
A three-armed, parallel group, superiority randomized
controlled clinical trial with repeated measurements at
four times: pretest, posttest, follow-up at three, six and
12months. Outcomes assessor, participant, care provider
and investigator will be blinded. Participants aged 18 to
70years will be randomly allocated 1:1:1 to one of three
study arms: a) Transdiagnostic guided Internet-delivered
intervention with synchronous assistance, b) Transdi-
agnostic self-guided Internet-delivered intervention,
c) Waiting list group. is study will follow the CON-
SORT statement [35] and the SPIRIT guidelines [36].
e study’s trial registration number is ClinicalTrials.gov
NCT05225701. Figure1 shows the flow chart of the study
design.
Participants
Sampling: non probabilistic, convenience sampling will
be performed. Participants aged 18 to 70years.
Eligibility criteria
Inclusion criteria: a) be of legal age; b) voluntarily par-
ticipate in the study; c) meet diagnostic criteria for
emotional disorders (anxiety/depression) and trauma,
stress-related disorders in accordance with the Inter-
national Neuropsychiatric Interview- Mini, version 5.0
[37], and show a score ≤ 25 in Beck’s Anxiety Depression
Inventory [38] and/or ≤ 30 in the Beck-BDI-II Depres-
sion Inventory [39]; d) have access to computer equip-
ment with an Internet connection; e) have a valid email
address; f) have basic digital skills in the use of an operat-
ing system and Internet browsing.
Exclusion criteria: a) psychotic disorder; b) alcohol and
drug abuse; c) medical condition whose severity or char-
acteristics prevent the intervention; d) be receiving psy-
chological and/or pharmacological treatment during the
study.
Elimination criteria: a) not accepting the conditions of
informed consent and b) absence on web or mobile plat-
forms for more than 15days or having missed two con-
secutive sessions of synchronous treatment sessions.
Recruitment procedure
Recruitment of participants will be carried out through
advertisements in digital media (institutional website,
thematic forums), as well as through dissemination on
social networks. e Transdiagnostic Internet-delivered
intervention program will be aimed at adults who will be
able to connect via the Internet from anywhere in Mex-
ico. Potential participants will be contacted via telephone
calls or emails. e research coordinator will provide the
participants with the information about the nature of the
study and clarify doubts. Participants will be asked for
their consent to participate. Independent evaluators will
determine the suitability of participants to be included
in the study based on the initial synchronous interview
(via videoconference or telephone) and the self-reports
related to the selection criteria that will be available in
digital format on the web platform.
Ethics approval andconsent toparticipate
e project is supported by the Ethics Committee of the
Faculty of Higher Studies Iztacala at National Autono-
mous University of Mexico (CE/FESI/082020/1363).
e development of the study will strictly adhere to
the guidelines expressed in the Mexican Psychologist’s
Code of Ethics [40] and the ethical standards that apply
to traditional clinical practice and recommendations
for online psychotherapy will be observed [41]. e
therapist will protect the patient’s confidentiality and
interaction records during the therapeutic process. All
participants must sign an informed consent form and the
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delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
rights to the confidentiality and privacy of personal data
will be respected. e participant’s personal data will be
encrypted through a standard algorithm and accessed
only by the principal investigator.
Randomization andblinding
Participants who meet the inclusion criteria for the study
will be randomly assigned to one of the study conditions.
Randomization will be performed by an independent
researcher unaware of the study characteristics through
online open software [42] in a 1:1:1 ratio per block satura-
tion of 12 per condition. e coordinator will inform the
patient of their participation in the study and, depending
on the characteristics of the study design condition, the
user will be assigned to the self-guided/ guided interven-
tion. Participants in the waiting list control group will
receive the access data needed to complete the interven-
tion 8weeks after randomization and will be assigned to
the intervention that has shown greater efficiency and
user satisfaction. All participants may withdraw from
treatment at any time.
Outcome’s assessor, participant and investigator will
be blinded. e researcher who administers baseline
assessments will be blind to the patients’ treatment
group. is researcher will be different from the one who
administers the other measures throughout the study.
Participant timeline anoutcomes assessment
Clinical evaluation of program users will be carried out
at five times (pre-post and three, six and 12months after
treatment). e instruments covered by the evaluation
protocol are aimed at obtaining information necessary
to assess whether the change, in addition to having sta-
tistical relevance, presents clinical significance and social
validation of psychological intervention, allowing to ana-
lyze the factors (procedures, goals and results) that will
influence the degree of patient satisfaction with respect
to the treatment used. Table1 provides an overview of
the measures used at each time point.
Diagnosis interview
International Neuropsychiatric Interview, Version 5.0.0
(MINI) [43]. It is a structured diagnostic interview. It
includes major psychiatric disorders of DSM-IV-R and
IDS-10. e Spanish version of Heinze [44] presents a
reliability with Kappa de > 0.75.
Fig. 1 Shows the flow chart of the study design
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delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
Symptom checklist (SCL-90). Screening instrument
to identify symptoms of various psychopathologies. It
is made up of 90 items that make up nine dimensions:
Somatization, obsessive–compulsive, interpersonal sen-
sitivity, depression, anxiety, hostility, phobic anxiety,
paranoia, and psychoticism [45]. Cronbach’s Alpha of all
subscales greater than 0.7.
Primary outcome measures
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-
5) [46]. is instrument describes the symptoms of post-
traumatic stress taking into consideration the diagnostic
criteria of activation, alterations, avoidance and reexper-
imentation. It has 20 items that are scored on a Likert-
type scale that goes from 0 (not at all) to 4 (totally). In its
adaptation to the Mexican population, the psychometric
properties of the scale show adequate internal consist-
ency with an alpha of 0.97, as well as an appropriate con-
vergent validity (rs = 0.58 to 0.88) [47]. Items are scored
on a Likert scale ranging from 0 to 4, where higher scores
indicate more pronounced PTSD symptoms. A cut-off
score of 33 was suggested to have a partial diagnosis of
PTSD.
Beck’s Anxiety Inventory (BAI) [48]. Self-administered
instrument consisting of 21 questions that determine
the severity of symptomatic and behavioral categories
of anxious symptomatology present in an individual by
means of a four-point scale (0 to 3), where 0 indicates
the absence of the symptom, and 3 its maximum sever-
ity. ese categories correspond to the symptoms that are
usually included to make the diagnosis of an anxiety dis-
order. Previous studies suggest that it is a measure with
high internal consistency and construct, divergent and
convergent validity [49].
Beck Depression Inventory (BDI-II) [50]. Consists of
21 items that fundamentally evaluate the clinical symp-
toms of melancholy and the intrusive thoughts present
in depression. Among depression measures, it is the one
with the highest percentage of cognitive items presented,
which is in line with Beck’s cognitive theory of depres-
sion. Validated Mexican version of the BDI [51] and for
version II (α = 87-0.92) [52].
Table 1 Participant timeline and outcome assessments
Timepoint Study Period
Enrolment Allocation Post-allocation
-t1 0 t1: Pretest t2: Posttest t3: Follow-up
1 (3months) t4: Follow-up
2 (6months)
Enrolment
Eligibility screen ✓
Informed consent ✓
Allocation ✓
Interventions
Transdiagnostic guided internet‑delivered intervention
with synchronous assistance (UP‑ guided)
Transdiagnostic self‑guided internet‑delivered interven‑
tion (UP‑unguided)
Wait list control (WL)
Assessments
Primary outcome measure
Mini International Neuropsychiatric Interview ✓
Symptom checklist (SCL‑90) ✓ ✓
Beck’s Anxiety Inventory (BAI) ✓ ✓ ✓ ✓
Beck’s Depression Inventory (BDI‑II) ✓ ✓ ✓ ✓
Posttraumatic Stress Disorder Checklist for DSM‑5 (PCL‑5) ✓ ✓ ✓ ✓
Scale of Difficulties in Emotional Regulation (DERS) ✓ ✓ ✓ ✓
Secondary outcome measures (during intervention)
General Anxiety and the Impairment Severity Scale
(OASIS)
General Depression and the Impairment Gravity Scale
(ODSIS)
Secondary outcome measures
Acceptance/Satisfaction/Usability Measures ✓
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delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
Secondary outcome measures
Scale of Difficulties in Emotional Regulation (DERS) [53].
It is a self-applied instrument that measures two dimen-
sions through 15 items, emotional regulation strategies
and awareness of emotions. e version validated in
Mexican population by De la Rosa etal. [54], presents a
Cronbach’s Alpha valued between 0.84—0.74.
General Anxiety and the Impairment Severity Scale
(OASIS) [55]. It consists of five questions within a scale of
0 to 4, which measures frequency, severity, and avoidance
of anxiety in different fields: work / academic interference
/ family, and deterioration of social and daily life. It has
good internal consistency (α = 0.80) and test–retest relia-
bility (k = 0.82). e Spanish language version confirmed
the factorial structure and reliability and validity data
obtained by the original authors: internal consistency in
both populations, in general and clinical (α = 0.86) and
test-fail reliability (k = 0.84) [56].
General Depression and the Impairment Gravity Scale
(ODSIS) [57]. is scale evaluates experiences related to
depression. It consists of five items with different answer
options ranging from 0 to 4 for each item. It measures the
frequency and severity of depression, as well as the level
of avoidance to work/academic/home interference, and
social life. In the Spanish language version, the internal
consistency has proven to be excellent, with a Cronbach
alpha between 0.91 and 0.94 and a good convergent and
discriminatory validity [56].
Opinion measures
Opinion on Treatment [58, 59]. is is measured by
means of four questions that inform on the level of sat-
isfaction with treatment, (for example “I would recom-
mend treatment to a friend or family member, treatment
is considered useful for your case and if you think the
treatment was difficult to manage or aversive. On a scale
of 1 (nothing) to 10 (very much).
Usability Scale (SUS) [60]. Measures the usability of a
tool, computer program, instrument, etc. It consists of 10
items within a five-point scale, where the 1 is totally at
odds and 5 totally agree.
e measures included in the evaluation protocol will
be delivered online, except for the mini-Interview, which
will be conducted by videoconference or / by telephone
by an evaluator.
Interventions
Transdiagnostic guided Internet‑delivered intervention
withsynchronous assistance (UP‑ guided)
Is an Internet-delivered intervention based on a manu-
alized unified protocol for the transdiagnostic treat-
ment for emotional disorders (to anxiety and mood
disorders -unipolar depression-) and derived from stress
and trauma disorders structured in a therapist hand-
book and a patient handbook [61]. e unified protocol
incorporates psychological techniques that have proven
their effectiveness [14] and includes the following thera-
peutic modules: 1) motivation for change, understand-
ing emotions, recognition and observation of emotional
response; 2) learning to observe experiences, evalua-
tion and re-evaluation of thoughts; 3) what is emotional
avoidance, emotion and behavior, and awareness and
tolerance of physical sensations; 4) emotional exposure
to physical sensations and situations and achievements,
maintenance and prevention of relapses.
E-moción is a self-applied treatment web system (web/
mobile app) based on a transdiagnostic approach for
emotional, stress and trauma-derived disorders organ-
ized into eight sequential modules (see Table2), it takes
about eight to 12weeks to complete it. All the modules
present the same structure: Module 0. Pre-evaluation,
Module 1. Psychoeducation and motivation for change
(e.g., understanding emotional reactions to stressors),
Module 2. Emotional Coping Skills (p. e.g., emotional
regulation), Module 3. Acceptance and awareness-rais-
ing skills focused on the present moment (e.g., mind-
fulness, metaphors); Module 4 and 5 Cognitive coping
skills (e.g., cognitive re-evaluation, cognitive flexibility);
Module 6 and 7. Behavioral coping skills (e.g., exposure
to emotional experiences), Module 8. Achievements,
maintenance, and prevention of relapses; Module 9. Post-
evaluation. e Internet-delivered treatment program
is compatible with desktop devices (PC/Mac), tablet or
mobile phone, and will allow participants to access the
intervention modules from anywhere and at their own
pace. Participants will be encouraged to advance one
module per week. e program also sends text mes-
sages with motivational content to remind participants
to access their modules. Each module includes exercises
and tasks for the practice of each technique.
Synchronous assistance andpsychological counseling
To monitor the participant’s progress, each user will be
assigned an advisor who will be a health personnel (psy-
chologists) to get a weekly personalized videoconferenc-
ing assistance and psychological counseling. e support
will be provided by experienced psychologists who will
have at least a bachelor’s degree in Clinical Psychology.
Before taking part in the trial, they will receive train-
ing on the transdiagnostic unified protocol and training
in telepsychology to ensure that everyone provides the
same support. e role of the psychological advisor is to
motivate, guide and listen to the doubts and comments
of each participant during one-hour individual online
weekly sessions.
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delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
Transdiagnostic self‑guided Internet delivered intervention
(UP‑ unguided)
Self-applied treatment web system based on a transdi-
agnostic approach for emotional and stress and trauma-
derived disorders. e system will contain eight modules
(Table2). e duration of the intervention program may
vary between users; however, the participant will have
access permits for a maximum period of 12 weeks. To
monitor the participant’s progress, at the end of each
intervention module, the user will be asked to answer
two brief questionnaires to assess anxiety and depression
(OASIS, ODSIS). All modules are sequential, allowing
the user to go step by step. is arm does not have per-
sonalized online assistance.
Under both conditions of intervention, automatic
emails with notifications will be sent out to prompt
participants to access the intervention if they have not
entered within the last 15days.
Waiting list control group (WL)
Participants on the waiting list group will be offered the
intervention after two months and will join the Transdi-
agnostic guided Internet-delivered intervention with syn-
chronous assistance.
Statistical analysis
Data management
e requested Personal Data will be processed for
research, teaching, and statistical purposes. ey will be
protected through a code (folio) that guarantees their
confidentiality. Access to the data will be limited to the
main researcher of the study and the institutional server
management technician. Likewise, the data will be kept
during the study and once completed, will be kept for
an additional period of up to five years to subsequently
be eliminated to avoid improper treatment of the same.
e information provided through the web and mobile
application will be treated with all appropriate security
measures, in accordance with the principles contained in
the Mexican Federal Law on Protection of Personal Data
Held by Private Parties, its Regulations and the Guide-
lines of the Privacy Notice of the United Mexican States.
Sample size
For the calculation of the sample size, suggestions
reported in the scientific literature regarding the size of
the effect in controlled clinical studies where they tested
the effectiveness of transdiagnostic interventions for
anxiety and depression via online platforms were con-
sidered. Cohen’s d index will be used for this study, as it
will be assumed that the variances of the three groups
will be homogeneous, otherwise the Hedges g-index
would be used. In addition, for the calculation of the
sample size, since the study will include 3 experimental
conditions a One-way ANOVA will be performed for
comparison between 3 groups. A conservative approach
was adopted and an average magnitude effect size of 0.25
(Cohen’s d) (equivalent to g × 0.5), a significance level
(α) of 0.05 (p < 0.05, 95% confidence) and a conventional
statistical power of 80% (1- β 0.8). For a priori analysis,
GPower*v3.1.6 software [62] was used and a required
sample size of 159 participants (53 per group) was
obtained. However, an additional 30% of participants will
be recruited keeping in mind attrition rates, as reported
in the literature on internet treatments [63, 64]. us, the
Table 2 Components of a transdiagnostic internet‑delivered intervention program
Modules Aims
Module 0 Pre‑evaluation
Module 1. Setting goals and staying motivated Increase motivation and commitment to treatment through the analysis of the ben‑
efits and costs of changing and not changing
Increase belief in the ability to successfully achieve desired changes (self‑efficacy)
Module 2. Understanding emotions Know the functional nature of emotions and learn about emotional response patterns,
including possible factors that maintain them
Module 3. Full emotional awareness Learn to pay present‑focused attention without judging your own experiences
Module 4. Cognitive flexibility Identify cognitive distortions to subsequently achieve flexibility in the way of thinking,
using reinterpretation strategies
Module 5. Opposing emotional behaviors Identify behaviors that are used to avoid unpleasant emotions and then use alterna‑
tive actions that approximate those emotions
Module 6. Understanding and coping with physical sensations Identify physical sensations and develop tolerance to them to reduce the perception
of threat
Module 7. Emotional exposures Increase tolerance to emotions based on exposure to them
Module 8. Recognize your achievements and look to the future Maintain long‑term benefits of treatment and prevent relapse
Module 9 Post‑evaluation
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 9 of 12
delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
required sample size is estimated to include 207 partici-
pants in total (69 participants per group).
Statistical analysis plan
Descriptive analyses will be carried out to character-
ize the study sample according to demographic vari-
ables: age, sex, occupation, residence, etc. Experimental
condition abandonment data associated with diagnosis,
intensity of clinical symptoms and sociodemographic
characteristics shall be considered. For the analysis of
indicators of psychopathology, the intensity of symptom-
atology, duration of the disorder in months, comorbid-
ity with other psychological problems will be reviewed.
To ascertain the homogeneity / heterogeneity in demo-
graphic and diagnostic variables that could affect the
effectiveness of the study among the two internet-deliv-
ered treatment groups (UP-guided vs UP-unguided)
and the control group (WL), a statistical analysis will be
performed before the intervention. e analysis of the
data will be carried out with the SPSS statistical pack-
age in its latest version. It will be calculated for categori-
cal and continuous variables, the One-way ANOVA.
e results shall be presented in three sections: a) con-
trast analyses to measure the effectiveness of interven-
tions, with specific measures of anxiety, depression,
and trauma-stress symptomatology analyzed before
and after the online treatment; b) analysis for moderat-
ing variable (emotional regulation), and c) acceptance/
satisfaction and usability measures of the online inter-
vention. To determine the effectiveness of the interven-
tion program, an analysis of repeated measures variance
will be computed through the SPSS statistical program,
which will compare the pretest measures against post-
test measures under the three experimental conditions.
e results will be controlled by performing effect size
analysis for each intervention group and between treat-
ment groups (UP-guided, UP-unguided) in relation to
the control group, through G*Power 3.1.6 software [62].
A conservative approach will be pursued, and the size of
the magnitude effect will be estimated using Cohen’s d
index, a significance level (α) of 0.05 (p < 0.05, which cor-
responds to 95% reliability) with a conventional statisti-
cal power of 80% (1- β × 0.8). For the analysis of clinical
significance associated with clinically significant change,
which refers to whether an intervention makes any real
difference in people in their daily lives [8], the Reliable
Change Rate (ICF) [65] will be calculated, using the cri-
teria of ± 1.64 and ± 1.96 in the area under the normal
curve, corresponding to 90 and 95% confidence levels.
is method has been chosen because as Jacobson etal.
[65] proposes, the amount of statistical change will first
be estimated to assess whether the observed difference
exceeds the error of measurement of the questionnaire,
and second, it will be estimated whether the participant’s
score has approached the mean of the functional group.
is will be estimated through the normative data of the
Mexican version of Beck’s anxiety and depression inven-
tories. Clinical change will be taken as relevant if the par-
ticipant reduces its levels to < 15 for anxiety, and < 16 for
depression. In addition, although the calculation is based
on the difference in score means, it incorporates the pre-
and post-treatment measurement error. us, to assess
whether there was a significant clinical change, both cri-
teria must be met: the change must be statistically reli-
able and clinically relevant. Multiple regression will be
used for mediation analyses to test the interaction effects
between reference predictor (emotional regulation) and
intervention condition, using macro/interface/Process
for SPSS.
Discussion
e present paper describes an Internet-delivered inter-
vention study protocol designed to evaluate the efficacy
and acceptability of a transdiagnostic guided Internet-
delivered intervention versus a transdiagnostic self-
guided Internet-delivered intervention for emotional,
trauma and stress-related disorders, and a waiting list
in a Mexican adults community sample, and also, to
examine the moderators of clinical change, particularly
emotional regulation, in the transdiagnostic Internet-
delivered intervention for emotional, trauma and stress-
related disorders.
Anxiety and mood disorders have been identified as the
main causes of psychological disability due to their high
prevalence, morbidity and comorbidity in the world and
in Mexico; coupled with the impact on the mental health
of the population caused by the health contingency due
to COVID-19, which has increased the incidence and/
or exacerbation of emotional crises and suicidal risk,
anxious symptoms, depression and acute stress that
could develop if not treated in a timely manner chroni-
cally and develop post-traumatic stress, pathological grief
and severe and serious emotional disorders. us, atten-
tion to this priority problem focused on psychological
intervention based on a transdiagnostic model that has
shown efficacy for the treatment of two or more spe-
cific disorders becomes relevant, and thereby contribute
to overcoming the inconveniences related to comorbid-
ity between disorders that prevent the full recovery of
the person. Likewise, the intervention provided by the
Internet will allow better dissemination and will allow
addressing the challenge of achieving a greater reach to
the vulnerable target population that has not been able to
access an effective intervention.
e study has strengths and clinical implications. First,
to the best of our knowledge, this is the first Mexican
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Page 10 of 12
delaRosa‑Gómezetal. BMC Psychiatry (2022) 22:537
randomized controlled clinical trial to apply a transdiag-
nostic Internet-delivered intervention to treat EDs and
Trauma, stress-related disorders. Second, this study pro-
poses two transdiagnostic Internet-delivered interven-
tion: guided and unguided, to compare the efficacious,
acceptance and satisfaction from the users’ view, which
will contribute in terms of feasibility of applying the
Internet-delivered intervention in different social context
to achieve generalization or external validity. Also, the
participants will be the direct beneficiaries of the results
of the study by reducing anxious and depressive symp-
toms and will be able to strengthen their coping skills in
the face of stressful events.
ere are some estimated limitations in the study, one
linked to the dropout rate, it is documented [18] that
Internet-delivered and self-administered interventions
show high dropout rates, particularly participants in the
waiting list group. e reasons could be the preference
for face-to-face treatments or the lack of access to the
Internet or electronic devices to receive the treatment.
To reduce this incidence of dropouts, it has been planned
to send weekly follow-up reminders and notifications to
users to motivate them to continue with the interven-
tion. Another limitation could be the small effect size
estimated between the intervention groups because both
are based on the same transdiagnostic Internet-delivered
intervention and the variant to be compared will be the
guide of a clinician who follows the intervention through
a weekly videoconferencing session. However, it is esti-
mated that a superiority will be found between the inter-
vention groups compared to the waiting list group.
Finally, the central mechanism of action on the project
is the development of a transdiagnostic Internet-deliv-
ered intervention program, which can be implemented
for dissemination in health centers, universities, com-
munity centers, etc. e study is expected to provide
evidence of an intervention with content rigorously elab-
orated and contextualized to society and culture which,
with the support of innovative technological resources,
provides functional strategies for target users.
Trial status
e study has not yet started with participant recruit-
ment, it will begin in September 2022. ere are no data
derived from this study; ere are no publications con-
taining the results of this study.
Abbreviations
BAI: Beck Anxiety Inventory; BDI‑II: Beck Depression Inventory ; CBT: Cognitive
Behavioral Treatments.; CONSORT: Consolidated Standards of Reporting Trials;
DERS: Scale of Difficulties in Emotional Regulation; DSM‑IV‑R: Diagnostic and
Statistical Manual of Mental Disorders, Fifth Edition, Text Revision; ED: Emo‑
tional Disorders.; ICF: Reliable Change Rate; IDS‑10: Inventory of Depressive
Symptomatology; MINI: International Neuropsychiatric Interview, Version 5.0.0;
OASIS: General Anxiety and the Impairment Severity Scale.; ODSIS: General
Depression and the Impairment Gravity Scale.; PC: Personal Computer; SPSS:
Statistical Package for Social Sciences; SPIRIT: Standard Protocol Items: Recom‑
mendations for Intervention Trials; SMP: Mexican Psychologist’s Code of Ethics;
SCL‑90: Symptom checklist; PCL‑5: Posttraumatic Stress Disorder Checklist for
DSM‑5; PTSD: Posttraumatic Stress Disorder; SUS: Usability Scale; UP: Unified
Protocol for the Treatment of Emotional Disorders.
Acknowledgements
ITSON‑CA‑30 Actores y procesos psicoeducativos, Centro de Atención e Inves-
tigación del Comportamiento Humano CAICH of Technological Institute of
Sonora.
Authors’ contributions
ARG conceived, designed, and got the funding of the study. ARG, LFP, EES
and CSTT wrote the first draft of the manuscript. RGF, ADR, PAL, RCV, EBR, RSR,
GMD, DDS, AHP, AFE, PV and MVS revised the manuscript and completed
the final draft. All authors contributed feedback, read, and approved the final
manuscript.
Funding
The study is supported by external funding of the National Council of Science
and Technology (Mexico), CONACyT. Call 2020–04: Research Projects and Social
Incidence in Mental Health and Addictions. Grant number 1401. The funding
institution had no role in the design of the study; data collection, analysis, and
interpretation; and will not have any role in the writing of the manuscript.
Availability of data and materials
Not applicable.
Declarations
Ethics approval and consent to participate
The study has the endorsement by the Research Ethics Committee of the Fac‑
ulty of Higher Studies Iztacala of the National Autonomous University of Méx‑
ico (CE/FESI/082020/1363), and it is registered in Clinical Trials (NCT05225701).
Registered February 4, 2022, https:// clini caltr ials. gov/ ct2/ show/ NCT05 225701.
All participants must give their written consent to participate.
Consent for publication
Not applicable in this study.
Competing interests
The authors declare that they have no competing interests.
Author details
1 Faculty of Higher Studies Iztacala, National Autonomous University of Mexico,
State of Mexico, Mexico. 2 Department of Social Sciences, Autonomous Univer‑
sity of Juarez, Ciudad Juárez, Mexico. 3 Department of Psychology, Techno‑
logical Institute of Sonora, Sonora, Mexico. 4 Health Sciences Area, Valencian
International University, Valencia, Spain. 5 Faculty of Psychology, National
Autonomous University of Mexico, Mexico City, Mexico. 6 Health Sciences
Department, Autonomous University of Ciudad Juarez, Ciudad Juárez, Mexico.
7 Faculty of Health Sciences, Autonomous University of Baja California, Tijuana
Baja California, Mexico. 8 Health of Tlaxcala, State Coordination of Mental
Health, Tlaxcala, Mexico.
Received: 23 May 2022 Accepted: 12 July 2022
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