Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study) (CHANGE)
14. August 2026 aktualisiert von: Max-Planck-Institute of Psychiatry
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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
30
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Natan Yusupov, MD, PhD
- Telefonnummer: 0049-89-30622-8338
- E-Mail: natan_yusupov@psych.mpg.de
Studienorte
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Munich, Deutschland, 80804
- Max-Planck-Institute of Psychiatry
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Kontakt:
- Peter Falkai, MD, Prof.
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: CHANGE intervention group
All enrolled participants receive the 8-session modularized group psychotherapy (CHANGE) in addition to treatment-as-usual (e.g., individual psychotherapy, pharmacotherapy, occupational therapy).
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)
Zeitfenster: T1 (8 weeks after baseline)
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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.
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T1 (8 weeks after baseline)
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Acceptability of CHANGE group therapy programme, measured by SAI (a German version of AIM (Acceptability of intervention) questionnaire, Weiner et al. 2017)
Zeitfenster: T1 (8 weeks after baseline)
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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.
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T1 (8 weeks after baseline)
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Appropriateness of CHANGE group therapy programme, measured by AIS (a German version of IAM (Appropriateness of intervention) questionnaire, Weiner et al. 2017)
Zeitfenster: T1 (8 weeks after baseline)
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Questionnaire, consisting originally of 4 items, rated on a 5-point Likert scale, ranging from 1 (completely disagree) to 5 (completely agree).
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T1 (8 weeks after baseline)
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Recruitment rate
Zeitfenster: T1 (8 weeks after baseline)
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number of consented participants / number of eligible patients
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T1 (8 weeks after baseline)
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Retention rate
Zeitfenster: T1 (8 weeks after baseline)
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number of participants completed post-assessment / number of consented participants
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T1 (8 weeks after baseline)
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Adherence rate
Zeitfenster: T1 (8 weeks after baseline)
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number of attended sessions / total number of sessions
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T1 (8 weeks after baseline)
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Dropout rate
Zeitfenster: T1 (8 weeks after baseline)
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number of dropouts / total number of enrolled participants
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T1 (8 weeks after baseline)
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Dropout reasons
Zeitfenster: T1 (8 weeks after baseline)
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structured categories and free text
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T1 (8 weeks after baseline)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)
Zeitfenster: T0 (baseline), T1 (8 weeks after baseline)
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Questionnaire, consisting of 10 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true)
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T0 (baseline), T1 (8 weeks after baseline)
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Change in adapted motivation, measured by adapted FEVER (German version of URICA (University of Rhode Island Change Assessment), Hasler et al. 2003).
Zeitfenster: T0 (baseline), T1 (8 weeks after baseline)
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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.
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T0 (baseline), T1 (8 weeks after baseline)
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Change in Quality of Life, measured by adapted WHOQOL-BREF (World Health Organization Quality of Life - Brief Version, German, Angermeyer et al. 2000)
Zeitfenster: T0 (baseline), T1 (8 weeks after baseline)
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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.
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T0 (baseline), T1 (8 weeks after baseline)
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Change in Perceived Competence, measured by adapted PCS (Perceived Competence Scale, Williams & Deci, 1996)
Zeitfenster: T0 (baseline), T1 (8 weeks after baseline)
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Questionnaire consisting of 16 items (4 per module) rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)
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T0 (baseline), T1 (8 weeks after baseline)
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Change in Knowledge concerning therapy content, measured by a self-constructed Multiple Choice Questionnaire
Zeitfenster: T0 (baseline), T1 (8 weeks after baseline)
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16 multiple choice questions (4 per module), each offering 4 response options with one correct answer
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T0 (baseline), T1 (8 weeks after baseline)
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Satisfaction, measured by Group Therapy Satisfaction scale (adapted from Westermann et al. 1996)
Zeitfenster: T1 (8 weeks after baseline)
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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).
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T1 (8 weeks after baseline)
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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General Feedback, measured by open-ended questions, self-constructed
Zeitfenster: T1 (8 weeks after baseline)
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Questionnaire consisting of 3 open-ended free-text questions
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T1 (8 weeks after baseline)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Natan Yusupov, MD, PhD, Max-Planck-Institute of Psychiatry
- Hauptermittler: Angelika Erhardt, MD, Prof., Max-Planck-Institute of Psychiatry
- Hauptermittler: Peter Falkai, MD, Prof., Max-Planck-Institute of Psychiatry
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
3. September 2026
Primärer Abschluss (Geschätzt)
1. Juni 2027
Studienabschluss (Geschätzt)
1. Juni 2027
Studienanmeldedaten
Zuerst eingereicht
11. August 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. August 2026
Zuerst gepostet (Tatsächlich)
19. August 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
19. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 26-0478
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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