Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study) (CHANGE)
14. august 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Natan Yusupov, MD, PhD
- Telefonnummer: 0049-89-30622-8338
- E-mail: natan_yusupov@psych.mpg.de
Studiesteder
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Munich, Tyskland, 80804
- Max-Planck-Institute of Psychiatry
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Kontakt:
- Peter Falkai, MD, Prof.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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General Feedback, measured by open-ended questions, self-constructed
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Natan Yusupov, MD, PhD, Max-Planck-Institute of Psychiatry
- Ledende efterforsker: Angelika Erhardt, MD, Prof., Max-Planck-Institute of Psychiatry
- Ledende efterforsker: Peter Falkai, MD, Prof., Max-Planck-Institute of Psychiatry
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
3. september 2026
Primær færdiggørelse (Anslået)
1. juni 2027
Studieafslutning (Anslået)
1. juni 2027
Datoer for studieregistrering
Først indsendt
11. august 2026
Først indsendt, der opfyldte QC-kriterier
14. august 2026
Først opslået (Faktiske)
19. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-0478
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