Clinical trial NCT05934019: Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)
Official title: Randomized Controlled Trial on the Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Transdiagnostic Mechanisms
Adolescent Psychology
Prevention
Online Intervention
Psychological Intervention
Mental Disorder in Adolescence, Subclinical
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 152
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a monocentric, two-arm, single-blinded, randomized controlled trial with CAU as control condition.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of self-reported general psychopathology
timeFrame: Baseline
measure: Level of self-reported general psychopathology
timeFrame: Month 2
measure: Level of self-reported general psychopathology
timeFrame: Month 6
measure: Level of self-reported general psychopathology
timeFrame: Month 9
measure: Level of self-reported general psychopathology
timeFrame: Month 12
Secondary outcomes:
measure: Level of social functioning
timeFrame: Baseline and month 12
measure: Level of role functioning
timeFrame: Baseline and month 12
measure: Time until onset of a mental disorder
timeFrame: Baseline and month 12
measure: Service Use
timeFrame: Month 12
measure: Depression
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Hypomania/bipolar symptoms (ASRM; Altman et al., 1997)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Anxiety (GAD-7; Löwe et al., 2008)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Obsessive-compulsive symptoms (SOCS; Piqueras et al., 2015)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Psychotic-like experiences (CAPE-P15; Capra et al., 2013).
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Alcohol/Substance abuse (CRAFFTd; Tossman et al., 2009)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Eating behavior (ChEDE-Q8; Kliem et al., 2016)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Conduct disorder (SDQ-s; Becker et al., 2018)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Non-suicidal self-injurious behavior
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Somatic symptoms (SSS8; Gierk et al., 2014)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Current stress level (PSS-4; Herrero & Meneses, 2006)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Adjustment to daily life (WSAS-Y; Jassi et al., 2020)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Behavioral avoidance (CEASE-A; Fairholm & Ehrenreich, 2008)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Self-perfectionism (F-MPS-B; Burgess et al., 2016)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Repetitive negative thinking (RTQ-10; McEvoy et al., 2017)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Emotion regulation (DERS-16; Bjureberg et al., 2016)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Intolerance of Uncertainty (IUS-12; Carleton et al., 2012)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Rejection sensitivity (C-RSQ; Downey et al., 2013)
timeFrame: Baseline, Month 2, 6, 9 and 12
measure: Satisfaction with the intervention (ZUF-8; Schmidt et al., 1989)
timeFrame: Week 8
measure: Adherence to the online-intervention
timeFrame: During the eight-week online-intervention
measure: Adherence
timeFrame: During the eight-week online-intervention
measure: Adherence
timeFrame: During the eight-week online-intervention
measure: Adherence
timeFrame: During the eight-week online-intervention
measure: Negative Intervention Effects (INEP; Ladwig, Rief & Nestoriuc, 2014)
timeFrame: Week 8
measure: Working Alliance (WAI-CA; Figueiredo, 2016)
timeFrame: Week 2, 4, 6, 8
measure: Therapy Motivation (MYTS; Breda & Riemer, 2012)
timeFrame: Baseline, Week 2, 4, 6, 8
measure: Acute suicidality
timeFrame: Baseline, Month 12
measure: Acute suicidality
timeFrame: Baseline, Week 2, 4, 6, Month 2, 6, 9, 12
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern, Division of Clinical Child and Adolescent Psychology
Study officials:
affiliation: University of Bern, Devision of Clinical Child and Adolescent Psychology
name: Stefanie J Schmidt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: