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Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study)

NCT07772180 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-19

No results posted yet for this study

Summary

This prospective, non-randomised, pre-post feasibility study evaluates CHANGE, a novel 8-session modularized cognitive behavioral group psychotherapy for young adults (18-25 years) with psychiatric disorders receiving inpatient or day-care treatment. All eligible participants (planned n=30) receive the intervention in addition to treatment-as-usual; there is no control arm. The primary aim is to assess feasibility, acceptability and appropriateness of the intervention (SMI (a German scale for feasibility), SAI (a German scale for acceptability), AIS (a German scale for appropriateness) scales; recruitment, retention, adherence and dropout rates). Secondary outcomes include perceived competence, self-efficacy (SWE), motivation (FEVER), satisfaction, quality of life (WHOQOL-BREF) and level of functioning (GAF), assessed before (T0) and after (T1) the intervention.

Conditions

  • Psychiatric Disorder

Interventions

OTHER

CHANGE - modularized group psychotherapy

8-session (weekly, 75 min/session), modularized group psychotherapy comprising 4 modules: (1) transition-specific psychoeducation, (2) suicidality, (3) media/internet/gaming addiction, (4) communication. Delivered in groups of max. 12 participants by a psychiatrist/psychotherapist in training under supervision, in addition to treatment-as-usual.

Sponsors & Collaborators

  • Max-Planck-Institute of Psychiatry

    lead OTHER

Principal Investigators

  • Natan Yusupov, MD, PhD · Max-Planck-Institute of Psychiatry

  • Angelika Erhardt, MD, Prof. · Max-Planck-Institute of Psychiatry

  • Peter Falkai, MD, Prof. · Max-Planck-Institute of Psychiatry

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-03
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772180 on ClinicalTrials.gov