Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study) (CHANGE)
14 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
30
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Natan Yusupov, MD, PhD
- Telefoonnummer: 0049-89-30622-8338
- E-mail: natan_yusupov@psych.mpg.de
Studie Locaties
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Munich, Duitsland, 80804
- Max-Planck-Institute of Psychiatry
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Contact:
- Peter Falkai, MD, Prof.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)
Tijdsspanne: 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).
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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 uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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General Feedback, measured by open-ended questions, self-constructed
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Natan Yusupov, MD, PhD, Max-Planck-Institute of Psychiatry
- Hoofdonderzoeker: Angelika Erhardt, MD, Prof., Max-Planck-Institute of Psychiatry
- Hoofdonderzoeker: Peter Falkai, MD, Prof., Max-Planck-Institute of Psychiatry
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
3 september 2026
Primaire voltooiing (Geschat)
1 juni 2027
Studie voltooiing (Geschat)
1 juni 2027
Studieregistratiedata
Eerst ingediend
11 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
14 augustus 2026
Eerst geplaatst (Werkelijk)
19 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
14 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 26-0478
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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