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NCT07772180
Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study)
Conditions: Psychiatric Disorder
Sex: All
Ages: 18 Years – 25 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Max-Planck-Institute of Psychiatry
Location: Max-Planck-Institute of Psychiatry Munich
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.
Eligibility Criteria
Inclusion Criteria:
1. Age \>=18 years and \< 26 years
2. Ability to provide written informed consent
Exclusion Criteria:
1. Age \< 18 years, age \>= 26 years
2. Lack of ability to provide written informed consent
3. Severe concomitant neurological or internal medical diseases
4. Severe cognitive impairment (IQ \< 80, severe learning disability, brain damage or pervasive developmental disorder)
5. Lack of eligibility for psychotherapy (e.g., insufficient language proficiency, hostile or uncooperative behavior)
6. Acute risk of self-harm or harm to others, including acute psychosis, acute mania, or acute suicidal behavior
7. Acute substance-based addiction
Source: ClinicalTrials.gov (NCT07772180). StuddyBuddy aggregates publicly available trial information.