AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in Switzerland

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.

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 groups in NCT05934019
Study groupRoleWhat they receive
EMPATIAExperimentalParticipants 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 UsualNo interventionParticipants 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.

  1. 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

  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 2

  3. 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

  4. 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

  5. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. Adherence to the online-intervention

    Assessed within the online-intervention. Indicator of adherence: time spent in program.

    Measured: During the eight-week online-intervention

  25. Adherence

    Assessed within the online-intervention. Indicator of adherence: number of clicks.

    Measured: During the eight-week online-intervention

  26. Adherence

    Assessed within the online-intervention. Indicator of adherence: number of modules completed.

    Measured: During the eight-week online-intervention

  27. Adherence

    Assessed within the online-intervention. Indicator of adherence: number of exercises completed.

    Measured: During the eight-week online-intervention

  28. 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

  29. 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

  30. 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

  31. Acute suicidality

    Assessed by the Kinder-DIPS interview (Margraf et al., 2017; Schneider et al., 2017).

    Measured: Baseline, Month 12

  32. 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.

  1. First posted6 Jul 2023
  2. Study start9 Jun 2023
  3. Primary completion18 Mar 2025
  4. Study completion1 Sep 2025

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in