Mental Health IssueEMPATIANCT05934019
Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)
A study testing EMPATIA 1 in people with Mental Health Issue and Transdiagnostic Mechanisms, run by University of Bern at 1 site in Switzerland.
Trial summary
The goal of this randomized controlled clinical trial is to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology of adolescents with subclinical symptoms compared to a Care As Usual (CAU) control group. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Mental Health Issue, Transdiagnostic Mechanisms, Adolescent Psychology
- What is being tested?
- EMPATIA 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jun 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed Consent signed by the subject (if the participant is ≥ 14 years) or signed by the legal guardians (if the participant is 12 or 13 years old).
- Subjects are between 12 and 18 years old.
- Subjects experience at least mild self-reported symptoms by scoring above the cut-off in at least one of the respective screening-instruments as assessed at the 12-month follow-up of the EMERGE- study.
- Subjects have access to the internet and a smart phone, tablet or personal computer.
- Subjects have sufficient knowledge of German.
Who cannot join
- Current or lifetime diagnosis according to the "Diagnostic Interview for Mental Disorders for Children and Adolescents" (Kinder-DIPS, Margraf et al., 2017; Schneider et al., 2017) at baseline.
- Score of '3' on the suicide item of the PHQ-A (Johnson et al., 2002) or active suicidal plans in the diagnostic telephone interview (Kinder- DIPS, Margraf et al., 2017; Schneider et al., 2017) at baseline.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Bern, Division of Clinical Child and Adolescent Psychology
Bern, 3012
About this study
Official title: Randomized Controlled Trial on the Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)
The goal of this randomized controlled clinical trial is to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology of adolescents with subclinical symptoms compared to a Care As Usual (CAU) control group. The primary objective is to:
- investigate the efficacy of the internet-delivered intervention on general psychopathology of adolescents with subclinical symptoms compared to CAU.
- secondary objectives include: clinician-rated interviews and self-report questionnaires on the level of social and role functioning, time until onset of a mental disorder and service use. Furthermore, changes in subclinical symptoms, transdiagnostic mechanisms and therapeutic as well as safety measures are assessed by online self-reports
Read more
Participants will use the internet-delivered intervention EMPATIA during eight weeks.
Researchers will compare intervention group to a Care As Usual (CAU) group to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology.
Read the detailed description
The overall objective of this study is to develop and evaluate an internet-delivered indicated prevention program for adolescents with subclinical symptoms designed to target transdiagnostic mechanisms of change. The internet-delivered program will be evaluated in a RCT compared to Care As Usual (CAU) including a 1-year follow-up period.
The online program EMPATIA aims to strengthen the well-being and mental health of young people in the long term. For example, in this program, young people learn, among other things, how to better deal with worries, stress, low self-confidence, conflicts with other people, or even unpleasant feelings such as anger, fear, or sadness. These are skills that are known to be helpful for the further development of all adolescents and make them more resilient to stress.
In this study, the investigators want to investigate whether the program is helpful, how it works, and which adolescents profit most. For the study, 152 adolescents from Switzerland are asked to participate in the EMPATIA-program online. In order to study the effectiveness scientifically, all adolescents will be randomly divided into two groups, so the differences can be compared. One group will get access to the EMPATIA-program already at the beginning, the other group after 12 months.
The contents of the EMPATIA-Program are evidence-based and well-established cognitive-behavioural interventions targeting transdiagnostic mechanisms that have been repeatedly identified to underlie several mental disorders in adolescents: behavioral avoidance, repetitive negative thinking including rumination, worry and intolerance of uncertainty, emotion regulation, self-critical perfectionism and rejection sensitivity. The program consists of 8 modules. It is recommended to complete one module every week with each module lasting about 60 minutes and to make use of additional examples, exercises for everyday life and diaries as often as possible. Furthermore, age- and gender specific topics and main testimonials are offered and can be selected by each participant. The intervention allows tailoring contents through topics that can be additionally selected, such as interpersonal conflicts, self-esteem, and social support and additional examples (e.g., if the predominant emotion experienced is anger vs. sadness). Information will generally be presented via short video-clips, examples from testimonials, audio files, interactive elements, and cartoons instead of text-based parts. At the end of the modules, there is a short quiz that allows participants to review and solidify what they have learned.
Participants will be guided (via program integrated chat function) throughout the intervention by e-coaches who are advanced master-students in Clinical Child and Adolescent Psychology.
- Conditions
- Mental Health Issue, Transdiagnostic Mechanisms, Adolescent Psychology, Prevention, Online Intervention, Psychological Intervention
- Being tested
- EMPATIA 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPATIA 1Device
The internet-program EMPATIA is hosted on a secure website https://selfhelp.psy.unibe.ch run by the Faculty of Human Sciences and is accessible from any regular internet browser. The software is not CE-marked as it has been developed for research purposes only. EMPATIA consists of 8 sessions and 1 booster session 3 weeks after the last session. It targets transdiagnostic mechanisms that have been identified in several mental disorders in adolescents: behavioral avoidance, repetitive negative thinking including intolerance of uncertainty, emotion, self-critical perfectionism and rejection sensitivity. The contents of EMPATIA are evidence-based and well-established cognitive-behavioral interventions dedicated to the respective transdiagnostic mechanism. The self-help program consists of psychoeducation, cognitive restructuring, relaxation and acceptance-based interventions, exposure and behavioral experiments and behavioral activation as treatment components.
| Study group | Role | What they receive |
|---|---|---|
| EMPATIA | Experimental | Participants in this group will access the online prevention program EMPATIA as a self-help online program during eight weeks. Receives: Device: EMPATIA 1 |
| Care As Usual | No intervention | Participants in this group will gain access to the online prevention program EMPATIA after 12 months. All other kinds of interventions during participation are allowed and will be recorded using the Client Sociodemographic and Service Receipt Inventory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of self-reported general psychopathology
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Measured: Baseline
Level of self-reported general psychopathology
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Measured: Month 2
Level of self-reported general psychopathology
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Measured: Month 6
Level of self-reported general psychopathology
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Measured: Month 9
Level of self-reported general psychopathology
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Measured: Month 12
Secondary outcomes (32)
Level of social functioning
Assessed with a structured interview ("Global Functioning Social"; GFsocial; Cornblatt et al., 2007). Scores range from 1 to 10 with higher scores indicating higher social functioning.
Measured: Baseline and month 12
Level of role functioning
Assessed with a structured interview ("Global Functioning Role"; GFrole; Cornblatt et al., 2007). Scores range from 1 to 10 with higher scores indicating higher role functioning.
Measured: Baseline and month 12
Time until onset of a mental disorder
Assessed with the Kinder-DIPS ("Diagnostic Interview for Mental Disorders in Children and Adolescents"; Schneider, Pflug, In-Albon, \& Margraf, 2017)
Measured: Baseline and month 12
Service Use
Assessed with the German version of the "Client Sociodemographic and Service Receipt Inventory" (CSSRI-EU; Chisholm et al., 2000; Roick et al., 2001).
Measured: Month 12
Depression
The "Patient Health Questionnaire-9 for Adolescents" (PHQ-A; Johnson et al., 2002) will be used to assess depressive symptoms. This self-report questionnaire consists of 9 items and higher scores indicate higher depressive symptoms.
Measured: Baseline, Month 2, 6, 9 and 12
Hypomania/bipolar symptoms (ASRM; Altman et al., 1997)
The "Altman Self-Rating Mania" Scale (ASRM) will be used to assess hypomania/bipolar symptoms. It is a 5-item Likert scale in which manic symptoms, corresponding to diagnostic criteria for mania, are rated from 0 to 4 according to increasing severity.
Measured: Baseline, Month 2, 6, 9 and 12
Anxiety (GAD-7; Löwe et al., 2008)
The GAD-7 will be used to measure general anxiety symptoms with 7 items. Higher scores indicate higher levels of anxiety.
Measured: Baseline, Month 2, 6, 9 and 12
Obsessive-compulsive symptoms (SOCS; Piqueras et al., 2015)
The "Short Obsessive-Compulsive Disorder Screener" (SOCS), a 6 item screening instrument, will be used to assess obsessive-compulsive symptoms.
Measured: Baseline, Month 2, 6, 9 and 12
Psychotic-like experiences (CAPE-P15; Capra et al., 2013).
The 15 item self-report questionnaire CAPE-P15 (Capra et al., 2013) assesses three domains: paranoid ideation, bizarre experiences, and perceptual anomalies. Scores can range from 15 to 75. Higher scores indicate higher severity of psychotic-like experiences.
Measured: Baseline, Month 2, 6, 9 and 12
Alcohol/Substance abuse (CRAFFTd; Tossman et al., 2009)
The CRAFFTd (Tossman et al., 2009) is a one-dimensional screening tool consisting of 6 questions. It will be used to screen for problematic substance consumption in adolescents. Higher scores indicate greater problematic substance consumption.
Measured: Baseline, Month 2, 6, 9 and 12
Eating behavior (ChEDE-Q8; Kliem et al., 2016)
The "Child Eating Disorder Examination-Questionnaire" (ChEDE-Q8) used in this study is an 8 item self-report scale to assess specific eating disorder psychopathology.
Measured: Baseline, Month 2, 6, 9 and 12
Conduct disorder (SDQ-s; Becker et al., 2018)
The subscale of the "Strengths and Difficulties Questionnaire" (SDQ-s; Becker et al., 2018) will be used to assess subclinical conduct problems. 5 items, higher scores indicate higher severity of conduct problems.
Measured: Baseline, Month 2, 6, 9 and 12
Non-suicidal self-injurious behavior
(Kinder-DIPS, Additional-Module NSSV; Margraf et al., 2017; Schneider et al., 2017). The suggested 7 questions by Margraf et al. (2017) and Schneider et al. (2017) will be assessed via self-report. Non-suicidal self-injurious behavior in the past year on five or more separate occasions are considered as subclinical.
Measured: Baseline, Month 2, 6, 9 and 12
Somatic symptoms (SSS8; Gierk et al., 2014)
The "Somatic Symptom Scale" (SSS-8) with 8-item will be used for the assessment of somatic symptom burden. Higher scores indicate higher somatic symptom burden.
Measured: Baseline, Month 2, 6, 9 and 12
Current stress level (PSS-4; Herrero & Meneses, 2006)
"Perceived Stress Scale" to assess current levels of stress (PSS-4), 4-item version with responses scored on a 1- to 5-point scale.
Measured: Baseline, Month 2, 6, 9 and 12
Adjustment to daily life (WSAS-Y; Jassi et al., 2020)
The WSAS-Y ("Work and Social Adjustment Scale-Youth") consists of five items that are rated on a 9-point Likert scale, generating a global score ranging from 0 to 40 (Jassi et al., 2020).
Measured: Baseline, Month 2, 6, 9 and 12
Behavioral avoidance (CEASE-A; Fairholm & Ehrenreich, 2008)
The "Checklist of Avoidance Strategy Engagement for Adolescents" (CEASE-A) is a psychometrically sound measure of avoidance (Kennedy, 2015). The 29-item checklist assesses frequency of engagement in avoidance behaviors to manage or avoid feelings of anxiety, anger, fear, or sadness on a 5-point Likert-type scale.
Measured: Baseline, Month 2, 6, 9 and 12
Self-perfectionism (F-MPS-B; Burgess et al., 2016)
The "Frost Multi-Dimensional Perfectionism Scale-Brief" (F-MPS-B; Burgess et al. 2016) is a brief 8-item version of the original F-MPS (35-items) (Frost et al. 1990). Items are rated on a 5-point Likert type scale with higher scores indicating greater perfectionism.
Measured: Baseline, Month 2, 6, 9 and 12
Repetitive negative thinking (RTQ-10; McEvoy et al., 2017)
The "Repetitive Thinking Questionnaire" (RTQ-10) is a 10-item scale to measure the common transdiagnostic factor repetitive negative thinking. Items are rated on a 5-point scale.
Measured: Baseline, Month 2, 6, 9 and 12
Emotion regulation (DERS-16; Bjureberg et al., 2016)
The "Difficulties in Emotion Regulation Scale" (DERS-16) is a 16-item self- report measure of emotion regulation difficulties (Bjureberg et al., 2016).
Measured: Baseline, Month 2, 6, 9 and 12
Intolerance of Uncertainty (IUS-12; Carleton et al., 2012)
The "Intolerance of Uncertainty Scale" is a 12-item short-form of the original 27-item Intolerance of Uncertainty Scale (Freeston et al., 1994). Items are scored on a 5-point Likert scale ranging from 1 to 5.
Measured: Baseline, Month 2, 6, 9 and 12
Rejection sensitivity (C-RSQ; Downey et al., 2013)
The "Children's Rejection Sensitivity Questionnaire" (C-RSQ; Downey et al., 1998) assesses the rejection sensitivity through 6 hypothetical interpersonal situations with ambiguous outcomes. Participants indicate on a 6-point Likert scale whether they would be nervous about the situation, how angry they would be about the situation, and what their outcome expectancy is.
Measured: Baseline, Month 2, 6, 9 and 12
Satisfaction with the intervention (ZUF-8; Schmidt et al., 1989)
The ZUF-8 is a questionnaire with 8 items for the global, one-dimensional assessment of patient satisfaction (Schmidt et al., 1989).
Measured: Week 8
Adherence to the online-intervention
Assessed within the online-intervention. Indicator of adherence: time spent in program.
Measured: During the eight-week online-intervention
Adherence
Assessed within the online-intervention. Indicator of adherence: number of clicks.
Measured: During the eight-week online-intervention
Adherence
Assessed within the online-intervention. Indicator of adherence: number of modules completed.
Measured: During the eight-week online-intervention
Adherence
Assessed within the online-intervention. Indicator of adherence: number of exercises completed.
Measured: During the eight-week online-intervention
Negative Intervention Effects (INEP; Ladwig, Rief & Nestoriuc, 2014)
Negative effects of the intervention will be assessed using a version of the "Inventory for the Assessment of Negative Effects in Psychotherapy" (Kinder-INEP; Bieda et al., 2018; INEP; Ladwig et al., 2014) adapted for online interventions and for children and adolescents. 12 Items.
Measured: Week 8
Working Alliance (WAI-CA; Figueiredo, 2016)
The "Working Alliance Inventory for guided Internet Interventions" (WAI-I; Gómez Penedo et al., 2020) is a self-report questionnaire that measures therapeutic alliance in online interventions with therapeutic support. "Working Alliance Inventory for Children and Adolescents" (WAI-CA) consists of 12 items and has good psychometric properties (Gómez Penedo et al., 2020).
Measured: Week 2, 4, 6, 8
Therapy Motivation (MYTS; Breda & Riemer, 2012)
The "Motivation for Youth's Treatment Scale" (MYTS; Breda \& Riemer, 2012) measures youth's motivation for therapy through a self-report questionnaire. The MYTS is a psychometrically based scale consisting of 8 items. Responses are rated on a 5-point likert scale. Higher ratings indicate higher motivation.
Measured: Baseline, Week 2, 4, 6, 8
Acute suicidality
Assessed by the Kinder-DIPS interview (Margraf et al., 2017; Schneider et al., 2017).
Measured: Baseline, Month 12
Acute suicidality
Suicidality will throughout the study be evaluated by the item 9 of the "Patient Health Questionnaire-9 for Adolescents" (i.e., PHQ-A; Johnson et al., 2002). With a score "3" as the highest score.
Measured: Baseline, Week 2, 4, 6, Month 2, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start9 Jun 2023
- Primary completion18 Mar 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a monocentric, two-arm, single-blinded, randomized controlled trial with CAU as control condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefanie J Schmidt, Prof. Dr., Principal investigator, University of Bern, Devision of Clinical Child and Adolescent Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934019
- Sponsor's protocol ID
- 2022-D0036
- Acronym
- EMPATIA
- Status last verified
- Feb 2026
- First submitted
- 26 May 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hirsig A, Hafeli XA, Schmidt SJ. Efficacy of a transdiagnostic Internet prevention approach in adolescents (EMPATIA study): study protocol of a randomized controlled trial. Trials. 2024 Aug 8;25(1):530. doi: 10.1186/s13063-024-08241-3.
PubMed 39118136
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)
- ClinicalTrials.gov ID
- NCT05934019
- Acronym / sponsor ID
- EMPATIA / 2022-D0036
- Conditions
- Mental Health Issue, Transdiagnostic Mechanisms, Adolescent Psychology, Prevention, Online Intervention, Psychological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled clinical trial is to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology of adolescents with subclinical symptoms compared to a Care As Usual (CAU) control group. The primary objective is to:
- investigate the efficacy of the internet-delivered intervention on general psychopathology of adolescents with subclinical symptoms compared to CAU.
- secondary objectives include: clinician-rated interviews and self-report questionnaires on the level of social and role functioning, time until onset of a mental disorder and service use. Furthermore, changes in subclinical symptoms, transdiagnostic mechanisms and therapeutic as well as safety measures are assessed by online self-reports
Participants will use the internet-delivered intervention EMPATIA during eight weeks.
Researchers will compare intervention group to a Care As Usual (CAU) group to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology.
Detailed description
The overall objective of this study is to develop and evaluate an internet-delivered indicated prevention program for adolescents with subclinical symptoms designed to target transdiagnostic mechanisms of change. The internet-delivered program will be evaluated in a RCT compared to Care As Usual (CAU) including a 1-year follow-up period.
The online program EMPATIA aims to strengthen the well-being and mental health of young people in the long term. For example, in this program, young people learn, among other things, how to better deal with worries, stress, low self-confidence, conflicts with other people, or even unpleasant feelings such as anger, fear, or sadness. These are skills that are known to be helpful for the further development of all adolescents and make them more resilient to stress.
In this study, the investigators want to investigate whether the program is helpful, how it works, and which adolescents profit most. For the study, 152 adolescents from Switzerland are asked to participate in the EMPATIA-program online. In order to study the effectiveness scientifically, all adolescents will be randomly divided into two groups, so the differences can be compared. One group will get access to the EMPATIA-program already at the beginning, the other group after 12 months.
The contents of the EMPATIA-Program are evidence-based and well-established cognitive-behavioural interventions targeting transdiagnostic mechanisms that have been repeatedly identified to underlie several mental disorders in adolescents: behavioral avoidance, repetitive negative thinking including rumination, worry and intolerance of uncertainty, emotion regulation, self-critical perfectionism and rejection sensitivity. The program consists of 8 modules. It is recommended to complete one module every week with each module lasting about 60 minutes and to make use of additional examples, exercises for everyday life and diaries as often as possible. Furthermore, age- and gender specific topics and main testimonials are offered and can be selected by each participant. The intervention allows tailoring contents through topics that can be additionally selected, such as interpersonal conflicts, self-esteem, and social support and additional examples (e.g., if the predominant emotion experienced is anger vs. sadness). Information will generally be presented via short video-clips, examples from testimonials, audio files, interactive elements, and cartoons instead of text-based parts. At the end of the modules, there is a short quiz that allows participants to review and solidify what they have learned.
Participants will be guided (via program integrated chat function) throughout the intervention by e-coaches who are advanced master-students in Clinical Child and Adolescent Psychology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The present study is a monocentric, two-arm, single-blinded, randomized controlled trial with CAU as control condition.
| Arm | Type | Receives |
|---|---|---|
| EMPATIA | Experimental | Device: EMPATIA 1Participants in this group will access the online prevention program EMPATIA as a self-help online program during eight weeks. |
| Care As Usual | No intervention | –Participants in this group will gain access to the online prevention program EMPATIA after 12 months. All other kinds of interventions during participation are allowed and will be recorded using the Client Sociodemographic and Service Receipt Inventory |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Informed Consent signed by the subject (if the participant is ≥ 14 years) or signed by the legal guardians (if the participant is 12 or 13 years old).
- Subjects are between 12 and 18 years old.
- Subjects experience at least mild self-reported symptoms by scoring above the cut-off in at least one of the respective screening-instruments as assessed at the 12-month follow-up of the EMERGE- study.
- Subjects have access to the internet and a smart phone, tablet or personal computer.
- Subjects have sufficient knowledge of German.
Key exclusion criteria (2 listed)
- Current or lifetime diagnosis according to the "Diagnostic Interview for Mental Disorders for Children and Adolescents" (Kinder-DIPS, Margraf et al., 2017; Schneider et al., 2017) at baseline.
- Score of '3' on the suicide item of the PHQ-A (Johnson et al., 2002) or active suicidal plans in the diagnostic telephone interview (Kinder- DIPS, Margraf et al., 2017; Schneider et al., 2017) at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPATIA 1The internet-program EMPATIA is hosted on a secure website https://selfhelp.psy.unibe.ch run by the Faculty of Human Sciences and is accessible from any regular internet browser. The software is not CE-marked as it has been developed for research purposes only. EMPATIA consists of 8 sessions and 1 booster session 3 weeks after the last session. It targets transdiagnostic mechanisms that have been identified in several mental disorders in adolescents: behavioral avoidance, repetitive negative thinking including intolerance of uncertainty, emotion, self-critical perfectionism and rejection sensitivity. The contents of EMPATIA are evidence-based and well-established cognitive-behavioral interventions dedicated to the respective transdiagnostic mechanism. The self-help program consists of psychoeducation, cognitive restructuring, relaxation and acceptance-based interventions, exposure and behavioral experiments and behavioral activation as treatment components. | Device | EMPATIA |
Primary outcome
Level of self-reported general psychopathology
Time frame: Baseline
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Level of self-reported general psychopathology
Time frame: Month 2
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Level of self-reported general psychopathology
Time frame: Month 6
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Level of self-reported general psychopathology
Time frame: Month 9
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
Level of self-reported general psychopathology
Time frame: Month 12
Assessed by the "Strength and Difficulties Questionnaire, self-report" (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology.
32 secondary outcomes
Level of social functioning
Time frame: Baseline and month 12
Level of role functioning
Time frame: Baseline and month 12
Time until onset of a mental disorder
Time frame: Baseline and month 12
Service Use
Time frame: Month 12
Depression
Time frame: Baseline, Month 2, 6, 9 and 12
Hypomania/bipolar symptoms (ASRM; Altman et al., 1997)
Time frame: Baseline, Month 2, 6, 9 and 12
Anxiety (GAD-7; Löwe et al., 2008)
Time frame: Baseline, Month 2, 6, 9 and 12
Obsessive-compulsive symptoms (SOCS; Piqueras et al., 2015)
Time frame: Baseline, Month 2, 6, 9 and 12
Psychotic-like experiences (CAPE-P15; Capra et al., 2013).
Time frame: Baseline, Month 2, 6, 9 and 12
Alcohol/Substance abuse (CRAFFTd; Tossman et al., 2009)
Time frame: Baseline, Month 2, 6, 9 and 12
Eating behavior (ChEDE-Q8; Kliem et al., 2016)
Time frame: Baseline, Month 2, 6, 9 and 12
Conduct disorder (SDQ-s; Becker et al., 2018)
Time frame: Baseline, Month 2, 6, 9 and 12
Non-suicidal self-injurious behavior
Time frame: Baseline, Month 2, 6, 9 and 12
Somatic symptoms (SSS8; Gierk et al., 2014)
Time frame: Baseline, Month 2, 6, 9 and 12
Current stress level (PSS-4; Herrero & Meneses, 2006)
Time frame: Baseline, Month 2, 6, 9 and 12
Adjustment to daily life (WSAS-Y; Jassi et al., 2020)
Time frame: Baseline, Month 2, 6, 9 and 12
Behavioral avoidance (CEASE-A; Fairholm & Ehrenreich, 2008)
Time frame: Baseline, Month 2, 6, 9 and 12
Self-perfectionism (F-MPS-B; Burgess et al., 2016)
Time frame: Baseline, Month 2, 6, 9 and 12
Repetitive negative thinking (RTQ-10; McEvoy et al., 2017)
Time frame: Baseline, Month 2, 6, 9 and 12
Emotion regulation (DERS-16; Bjureberg et al., 2016)
Time frame: Baseline, Month 2, 6, 9 and 12
Intolerance of Uncertainty (IUS-12; Carleton et al., 2012)
Time frame: Baseline, Month 2, 6, 9 and 12
Rejection sensitivity (C-RSQ; Downey et al., 2013)
Time frame: Baseline, Month 2, 6, 9 and 12
Satisfaction with the intervention (ZUF-8; Schmidt et al., 1989)
Time frame: Week 8
Adherence to the online-intervention
Time frame: During the eight-week online-intervention
Adherence
Time frame: During the eight-week online-intervention
Adherence
Time frame: During the eight-week online-intervention
Adherence
Time frame: During the eight-week online-intervention
Negative Intervention Effects (INEP; Ladwig, Rief & Nestoriuc, 2014)
Time frame: Week 8
Working Alliance (WAI-CA; Figueiredo, 2016)
Time frame: Week 2, 4, 6, 8
Therapy Motivation (MYTS; Breda & Riemer, 2012)
Time frame: Baseline, Week 2, 4, 6, 8
Acute suicidality
Time frame: Baseline, Month 12
Acute suicidality
Time frame: Baseline, Week 2, 4, 6, Month 2, 6, 9, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Derived from this study: PubMed 39118136Hirsig A, Hafeli XA, Schmidt SJ. Efficacy of a transdiagnostic Internet prevention approach in adolescents (EMPATIA study): study protocol of a randomized controlled trial. Trials. 2024 Aug 8;25(1):530. doi: 10.1186/s13063-024-08241-3.
- Homepage with study information for adolescents and care giver/parentsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanie J Schmidt, Prof. Dr. principal investigator
University of Bern, Devision of Clinical Child and Adolescent Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMPATIA 1 in people with Mental Health Issue and Transdiagnostic Mechanisms, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of self-reported general psychopathology (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05934019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.