Skip to main content
OpenTrials
Completed

NCT Number: NCT05934019

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern, Division of Clinical Child and Adolescent Psychology

Bern, 3012, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

EMPATIA 1

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Level of social functioning

    Time frame: Baseline and month 12

    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.

  2. Level of role functioning

    Time frame: Baseline and month 12

    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.

  3. Time until onset of a mental disorder

    Time frame: Baseline and month 12

    Assessed with the Kinder-DIPS ("Diagnostic Interview for Mental Disorders in Children and Adolescents"; Schneider, Pflug, In-Albon, & Margraf, 2017)

  4. Service Use

    Time frame: Month 12

    Assessed with the German version of the "Client Sociodemographic and Service Receipt Inventory" (CSSRI-EU; Chisholm et al., 2000; Roick et al., 2001).

  5. Depression

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  6. Hypomania/bipolar symptoms (ASRM; Altman et al., 1997)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  7. Anxiety (GAD-7; Löwe et al., 2008)

    Time frame: Baseline, Month 2, 6, 9 and 12

    The GAD-7 will be used to measure general anxiety symptoms with 7 items. Higher scores indicate higher levels of anxiety.

  8. Obsessive-compulsive symptoms (SOCS; Piqueras et al., 2015)

    Time frame: Baseline, Month 2, 6, 9 and 12

    The "Short Obsessive-Compulsive Disorder Screener" (SOCS), a 6 item screening instrument, will be used to assess obsessive-compulsive symptoms.

  9. Psychotic-like experiences (CAPE-P15; Capra et al., 2013).

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  10. Alcohol/Substance abuse (CRAFFTd; Tossman et al., 2009)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  11. Eating behavior (ChEDE-Q8; Kliem et al., 2016)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  12. Conduct disorder (SDQ-s; Becker et al., 2018)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  13. Non-suicidal self-injurious behavior

    Time frame: Baseline, Month 2, 6, 9 and 12

    (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.

  14. Somatic symptoms (SSS8; Gierk et al., 2014)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  15. Current stress level (PSS-4; Herrero & Meneses, 2006)

    Time frame: Baseline, Month 2, 6, 9 and 12

    "Perceived Stress Scale" to assess current levels of stress (PSS-4), 4-item version with responses scored on a 1- to 5-point scale.

  16. Adjustment to daily life (WSAS-Y; Jassi et al., 2020)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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).

  17. Behavioral avoidance (CEASE-A; Fairholm & Ehrenreich, 2008)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  18. Self-perfectionism (F-MPS-B; Burgess et al., 2016)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  19. Repetitive negative thinking (RTQ-10; McEvoy et al., 2017)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  20. Emotion regulation (DERS-16; Bjureberg et al., 2016)

    Time frame: Baseline, Month 2, 6, 9 and 12

    The "Difficulties in Emotion Regulation Scale" (DERS-16) is a 16-item self- report measure of emotion regulation difficulties (Bjureberg et al., 2016).

  21. Intolerance of Uncertainty (IUS-12; Carleton et al., 2012)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  22. Rejection sensitivity (C-RSQ; Downey et al., 2013)

    Time frame: Baseline, Month 2, 6, 9 and 12

    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.

  23. Satisfaction with the intervention (ZUF-8; Schmidt et al., 1989)

    Time frame: Week 8

    The ZUF-8 is a questionnaire with 8 items for the global, one-dimensional assessment of patient satisfaction (Schmidt et al., 1989).

  24. Adherence to the online-intervention

    Time frame: During the eight-week online-intervention

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

  25. Adherence

    Time frame: During the eight-week online-intervention

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

  26. Adherence

    Time frame: During the eight-week online-intervention

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

  27. Adherence

    Time frame: During the eight-week online-intervention

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

  28. Negative Intervention Effects (INEP; Ladwig, Rief & Nestoriuc, 2014)

    Time frame: Week 8

    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.

  29. Working Alliance (WAI-CA; Figueiredo, 2016)

    Time frame: Week 2, 4, 6, 8

    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).

  30. Therapy Motivation (MYTS; Breda & Riemer, 2012)

    Time frame: Baseline, Week 2, 4, 6, 8

    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.

  31. Acute suicidality

    Time frame: Baseline, Month 12

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

  32. Acute suicidality

    Time frame: Baseline, Week 2, 4, 6, Month 2, 6, 9, 12

    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.

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

Randomized Controlled Trial on the Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)

Acronym: EMPATIA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2023
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.