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

NCT07772180 | Not Yet Recruiting

• 1 other identifier: 26-0478
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Young adults; transitional psychiatry; group psychotherapy; feasibility study; psychoeducation; suicidality; media/internet/gaming addiction; communication skills; self-efficacy

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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).

  T1 (8 weeks after baseline)

• Recruitment rate

  number of consented participants / number of eligible patients

  T1 (8 weeks after baseline)

• Retention rate

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

  T1 (8 weeks after baseline)

• Adherence rate

  number of attended sessions / total number of sessions

  T1 (8 weeks after baseline)

• Dropout rate

  number of dropouts / total number of enrolled participants

  T1 (8 weeks after baseline)

• Dropout reasons

  structured categories and free text

  T1 (8 weeks after baseline)

Secondary Outcomes (6)

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

  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).

  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)

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

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

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

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

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

Other Outcomes (1)

• General Feedback, measured by open-ended questions, self-constructed

  T1 (8 weeks after baseline)

Study Arms (1)

CHANGE intervention group

EXPERIMENTAL

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

Interventions

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.

CHANGE intervention group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max-Planck-Institute of Psychiatry

Munich, 80804, Germany

Location

Related Publications (6)

• 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.

  BACKGROUND

• 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.

  PMID: 14528410 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

• 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.

  PMID: 8636897 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Natan Yusupov, MD, PhD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

• Angelika Erhardt, MD, Prof.

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

• Peter Falkai, MD, Prof.

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natan Yusupov, MD, PhD

CONTACT

0049-89-30622-8338; natan_yusupov@psych.mpg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

DE (1)