Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)

NCT05934019 | Completed DMC

• 1 other identifier: 2022-D0036
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue; Prevention; Transdiagnostic Mechanisms; Mental Disorder in Adolescence, Subclinical; Adolescent Psychology; Online Intervention; Psychological Intervention

Outcome Measures

Primary Outcomes (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.

  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.

  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.

  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.

  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.

  Month 12

Secondary Outcomes (32)

• Level of social functioning

  Baseline and month 12

• Level of role functioning

  Baseline and month 12

• Time until onset of a mental disorder

  Baseline and month 12

• Service Use

  Month 12

• Depression

  Baseline, Month 2, 6, 9 and 12

Study Arms (2)

EMPATIA

EXPERIMENTAL

Participants in this group will access the online prevention program EMPATIA as a self-help online program during eight weeks.

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

Interventions

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.

EMPATIA

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University of Bern, Division of Clinical Child and Adolescent Psychology

Bern, 3012, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39118136 DERIVED

Related Links

• Homepage with study information for adolescents and care giver/parents

Study Officials

• Stefanie J Schmidt, Prof. Dr.

  University of Bern, Devision of Clinical Child and Adolescent Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study participants cannot be blinded regarding the intervention condition as they realize whether they are in the condition using an online-program or not. Members of the study team guiding the participants as e-coaches during the online-program cannot be blinded as it is obvious for them that this is the condition receiving the online-program. Members of the study team who are conducting the diagnostic interviews do not have any other contact with the participants and will thus be blinded regarding the participants' assignment to the group conditions (EMPATIA vs. CAU).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The present study is a monocentric, two-arm, single-blinded, randomized controlled trial with CAU as control condition.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 6, 2023
• Study Start: June 9, 2023
• Primary Completion: March 18, 2025
• Study Completion: September 1, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)