Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07772180

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Psychiatric Disorder Behavior Behavioral Symptoms Mental Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Max-Planck-Institute of Psychiatry

Munich, 80804, Germany

Location contact

Peter Falkai, MD, Prof.

CONTACT

About this study

Mental disorders frequently begin before age 25, during the 'transition' phase between adolescent and adult psychiatric care, a period of ongoing biopsychosocial development that is often insufficiently addressed by conventional, age-segregated care systems. CHANGE (Create Health in Adolescence for New and Genuine Experiences) was developed to address this gap with four thematic modules delivered over 8 weekly 75-minute group sessions (max. 12 participants/group): (1) transition-specific psychoeducation, (2) suicidality, (3) media/internet/gaming addiction, and (4) communication. Sessions are led by a psychiatrist/psychotherapist in training under supervision, using a standardized therapist and patient manual. Participants are recruited from inpatient and day-care units at the Max Planck Institute of Psychiatry; screening, informed consent and baseline assessment (T0) precede the intervention, with a post-intervention assessment (T1) at completion. Analyses follow the CONSORT/TIDieR extension for pilot and feasibility trials (non-randomised items excluded), using descriptive statistics for feasibility/acceptability/appropriateness metrics and linear mixed-effects models for pre-post change in secondary outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >=18 years and < 26 years
  • Ability to provide written informed consent

Exclusion criteria

  • Age < 18 years, age >= 26 years
  • Lack of ability to provide written informed consent
  • Severe concomitant neurological or internal medical diseases
  • Severe cognitive impairment (IQ < 80, severe learning disability, brain damage or pervasive developmental disorder)
  • Lack of eligibility for psychotherapy (e.g., insufficient language proficiency, hostile or uncooperative behavior)
  • Acute risk of self-harm or harm to others, including acute psychosis, acute mania, or acute suicidal behavior
  • Acute substance-based addiction

Treatment and study plan

CHANGE - modularized group psychotherapy

Other

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.

Primary outcomes

  1. Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)

    Time frame: T1 (8 weeks after baseline)

    Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree), item 5 was added.

  2. Acceptability of CHANGE group therapy programme, measured by SAI (a German version of AIM (Acceptability of intervention) questionnaire, Weiner et al. 2017)

    Time frame: T1 (8 weeks after baseline)

    Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree), item 5 was added.

  3. Appropriateness of CHANGE group therapy programme, measured by AIS (a German version of IAM (Appropriateness of intervention) questionnaire, Weiner et al. 2017)

    Time frame: T1 (8 weeks after baseline)

    Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree).

  4. Recruitment rate

    Time frame: T1 (8 weeks after baseline)

    number of consented participants / number of eligible patients

  5. Retention rate

    Time frame: T1 (8 weeks after baseline)

    number of participants completed post-assessment / number of consented participants

  6. Adherence rate

    Time frame: T1 (8 weeks after baseline)

    number of attended sessions / total number of sessions

  7. Dropout rate

    Time frame: T1 (8 weeks after baseline)

    number of dropouts / total number of enrolled participants

  8. Dropout reasons

    Time frame: T1 (8 weeks after baseline)

    structured categories and free text

Secondary outcomes

  1. Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)

    Time frame: T0 (baseline), T1 (8 weeks after baseline)

    Questionnaire, consisting of 10 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true)

  2. Change in adapted motivation, measured by adapted FEVER (German version of URICA (University of Rhode Island Change Assessment), Hasler et al. 2003).

    Time frame: T0 (baseline), T1 (8 weeks after baseline)

    Questionnaire consisting of 24 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), item 11 was adapted.

  3. Change in Quality of Life, measured by adapted WHOQOL-BREF (World Health Organization Quality of Life - Brief Version, German, Angermeyer et al. 2000)

    Time frame: T0 (baseline), T1 (8 weeks after baseline)

    Questionnaire consisting of 26 items rated on a 5-point Likert scale with response formats varying by item (intensity, capacity, frequency, or satisfaction), item 10 was adapted.

  4. Change in Perceived Competence, measured by adapted PCS (Perceived Competence Scale, Williams & Deci, 1996)

    Time frame: T0 (baseline), T1 (8 weeks after baseline)

    Questionnaire consisting of 16 items (4 per module) rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)

  5. Change in Knowledge concerning therapy content, measured by a self-constructed Multiple Choice Questionnaire

    Time frame: T0 (baseline), T1 (8 weeks after baseline)

    16 multiple choice questions (4 per module), each offering 4 response options with one correct answer

  6. Satisfaction, measured by Group Therapy Satisfaction scale (adapted from Westermann et al. 1996)

    Time frame: T1 (8 weeks after baseline)

    Questionnaire consisting of 14 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (completely true). 2 model specific items were added per therapy module (8 added in total).

Other outcomes

  1. General Feedback, measured by open-ended questions, self-constructed

    Time frame: T1 (8 weeks after baseline)

    Questionnaire consisting of 3 open-ended free-text questions

Study contacts

Contact information is provided by the study sponsor or research team.

Natan Yusupov, MD, PhD

CONTACT

[email protected]

0049-89-30622-8338

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Psychiatry

Other

Registry information

Official study title

Feasibility and Acceptability of CHANGE (Create Health in Adolescence for New and Genuine Experiences): A Modular Cognitive Behavioral Group Psychotherapy for Young Adults With Psychiatric Disorders

Acronym: CHANGE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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.

Related clinical trials

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