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Psychiatric DisorderCHANGENCT07772180

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

A study testing CHANGE - modularized group psychotherapy in people with Psychiatric Disorder, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Psychiatric Disorder
What is being tested?
CHANGE - modularized group psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
3 Sep 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Natan Yusupov, MD, PhD contact

0049-89-30622-8338

natan_yusupov@psych.mpg.de

Germany1 site

  • Max-Planck-Institute of Psychiatry

    Munich, 80804

    Peter Falkai, MD, Prof.

Other trials in Germany

About this study

Official 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

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.

Read the detailed description

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.

Being tested
CHANGE - modularized group psychotherapy
Keywords
Young adults, transitional psychiatry, group psychotherapy, feasibility study, psychoeducation, suicidality, media/internet/gaming addiction, communication skills, self-efficacy
Medical subject headings
Mental Disorders, Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHANGE - modularized group psychotherapyOther

    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.

Study groups in NCT07772180
Study groupRoleWhat they receive
CHANGE intervention groupExperimentalAll enrolled participants receive the 8-session modularized group psychotherapy (CHANGE) in addition to treatment-as-usual (e.g., individual psychotherapy, pharmacotherapy, occupational therapy).
Receives: Other: CHANGE - modularized group psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: T1 (8 weeks after baseline)

  2. 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.

    Measured: T1 (8 weeks after baseline)

  3. 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).

    Measured: T1 (8 weeks after baseline)

  4. Recruitment rate

    number of consented participants / number of eligible patients

    Measured: T1 (8 weeks after baseline)

  5. Retention rate

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

    Measured: T1 (8 weeks after baseline)

  6. Adherence rate

    number of attended sessions / total number of sessions

    Measured: T1 (8 weeks after baseline)

  7. Dropout rate

    number of dropouts / total number of enrolled participants

    Measured: T1 (8 weeks after baseline)

  8. Dropout reasons

    structured categories and free text

    Measured: T1 (8 weeks after baseline)

Secondary outcomes (6)

  1. 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)

    Measured: T0 (baseline), T1 (8 weeks after baseline)

  2. 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.

    Measured: T0 (baseline), T1 (8 weeks after baseline)

  3. 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.

    Measured: T0 (baseline), T1 (8 weeks after baseline)

  4. 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)

    Measured: T0 (baseline), T1 (8 weeks after baseline)

  5. 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

    Measured: T0 (baseline), T1 (8 weeks after baseline)

  6. 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).

    Measured: T1 (8 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start3 Sep 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All eligible participants receive the modularized CHANGE group psychotherapy in addition to treatment-as-usual; there is no control or comparator arm. Outcomes are assessed before (T0) and after (T1) the 8-session intervention (single-arm, pre-post design).
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07772180
Sponsor's protocol ID
26-0478
Acronym
CHANGE
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Angermeyer, M. C., Kilian, R., & Matschinger, H. (2000). WHOQOL-100 und WHOQOL-BREF. Handbuch für die deutschsprachige Version der WHO Instrumente zur Erfassung von Lebensqualität. Göttingen: Hogrefe.

  • Hasler G, Klaghofer R, Buddeberg C. [The University of Rhode Island Change Assessment Scale (URICA)]. Psychother Psychosom Med Psychol. 2003 Sep-Oct;53(9-10):406-11. doi: 10.1055/s-2003-42172. German.

    PubMed 14528410

  • Schwarzer, R. & Jerusalem, M. (2003). SWE. Skala zur Allgemeinen Selbstwirksamkeitserwartung [Verfahrensdokumentation, Autorenbeschreibung und Fragebogen]. In Leibniz-Institut für Psychologie (ZPID) (Hrsg.), Open Test Archive. Trier: ZPID. https://doi.org/10.23668/psycharchives.4515

  • Westermann, R., Elke, H., Spies, K., & Trautwein, U. (1996). Identifikation und Erfassung von Komponenten der Studienzufriedenheit. Psychologie in Erziehung und Unterricht, 43(1), 1-22.

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PubMed 28851459

  • Williams GC, Deci EL. Internalization of biopsychosocial values by medical students: a test of self-determination theory. J Pers Soc Psychol. 1996 Apr;70(4):767-79. doi: 10.1037//0022-3514.70.4.767.

    PubMed 8636897

Questions about this trial

What is this clinical trial studying?

A study testing CHANGE - modularized group psychotherapy in people with Psychiatric Disorder, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natan Yusupov, MD, PhD (0049-89-30622-8338, natan_yusupov@psych.mpg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07772180, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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