Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study) (CHANGE)
14 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Natan Yusupov, MD, PhD
- Numero di telefono: 0049-89-30622-8338
- Email: natan_yusupov@psych.mpg.de
Luoghi di studio
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Munich, Germania, 80804
- Max-Planck-Institute of Psychiatry
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Contatto:
- Peter Falkai, MD, Prof.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)
Lasso di tempo: 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).
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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General Feedback, measured by open-ended questions, self-constructed
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Natan Yusupov, MD, PhD, Max-Planck-Institute of Psychiatry
- Investigatore principale: Angelika Erhardt, MD, Prof., Max-Planck-Institute of Psychiatry
- Investigatore principale: Peter Falkai, MD, Prof., Max-Planck-Institute of Psychiatry
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
3 settembre 2026
Completamento primario (Stimato)
1 giugno 2027
Completamento dello studio (Stimato)
1 giugno 2027
Date di iscrizione allo studio
Primo inviato
11 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 agosto 2026
Primo Inserito (Effettivo)
19 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 26-0478
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .