An interventional study of CHANGE - modularized group psychotherapy in Psychiatric Disorder, sponsored by Max-Planck-Institute of Psychiatry. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Max-Planck-Institute of Psychiatry · Not applicable, Interventional, and Treatment
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.
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.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Max-Planck-Institute of Psychiatry is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled participants receive the 8-session modularized group psychotherapy (CHANGE) in addition to treatment-as-usual (e.g., individual psychotherapy, pharmacotherapy, occupational therapy).
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.
Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)
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.
Time frame: T1 (8 weeks after baseline)
Acceptability of CHANGE group therapy programme, measured by SAI (a German version of AIM (Acceptability of intervention) questionnaire, Weiner et al. 2017)
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.
Time frame: T1 (8 weeks after baseline)
Appropriateness of CHANGE group therapy programme, measured by AIS (a German version of IAM (Appropriateness of intervention) questionnaire, Weiner et al. 2017)
Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree).
Time frame: T1 (8 weeks after baseline)
Recruitment rate
number of consented participants / number of eligible patients
Time frame: T1 (8 weeks after baseline)
Retention rate
number of participants completed post-assessment / number of consented participants
Time frame: T1 (8 weeks after baseline)
Adherence rate
number of attended sessions / total number of sessions
Time frame: T1 (8 weeks after baseline)
Dropout rate
number of dropouts / total number of enrolled participants
Time frame: T1 (8 weeks after baseline)
Dropout reasons
structured categories and free text
Time frame: T1 (8 weeks after baseline)
Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)
Questionnaire, consisting of 10 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true)
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Change in adapted motivation, measured by adapted FEVER (German version of URICA (University of Rhode Island Change Assessment), Hasler et al. 2003).
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.
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Change in Quality of Life, measured by adapted WHOQOL-BREF (World Health Organization Quality of Life - Brief Version, German, Angermeyer et al. 2000)
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.
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Change in Perceived Competence, measured by adapted PCS (Perceived Competence Scale, Williams & Deci, 1996)
Questionnaire consisting of 16 items (4 per module) rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Change in Knowledge concerning therapy content, measured by a self-constructed Multiple Choice Questionnaire
16 multiple choice questions (4 per module), each offering 4 response options with one correct answer
Time frame: T0 (baseline), T1 (8 weeks after baseline)
Satisfaction, measured by Group Therapy Satisfaction scale (adapted from Westermann et al. 1996)
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).
Time frame: T1 (8 weeks after baseline)
General Feedback, measured by open-ended questions, self-constructed
Questionnaire consisting of 3 open-ended free-text questions
Time frame: T1 (8 weeks after baseline)
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 9 months is below that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Max-Planck-Institute of Psychiatry