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

14 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Munich, Allemagne, 80804
        • Max-Planck-Institute of Psychiatry
        • Contact:
          • Peter Falkai, MD, Prof.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Age >=18 years and < 26 years
  2. Ability to provide written informed consent

Exclusion Criteria:

  1. Age < 18 years, age >= 26 years
  2. Lack of ability to provide written informed consent
  3. Severe concomitant neurological or internal medical diseases
  4. Severe cognitive impairment (IQ < 80, severe learning disability, brain damage or pervasive developmental disorder)
  5. Lack of eligibility for psychotherapy (e.g., insufficient language proficiency, hostile or uncooperative behavior)
  6. Acute risk of self-harm or harm to others, including acute psychosis, acute mania, or acute suicidal behavior
  7. Acute substance-based addiction

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Autre: CHANGE - modularized group psychotherapy
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)
Délai: T1 (8 weeks after baseline)
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)
Délai: T1 (8 weeks after baseline)
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)
Délai: T1 (8 weeks after baseline)
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
Délai: T1 (8 weeks after baseline)
number of consented participants / number of eligible patients
T1 (8 weeks after baseline)
Retention rate
Délai: T1 (8 weeks after baseline)
number of participants completed post-assessment / number of consented participants
T1 (8 weeks after baseline)
Adherence rate
Délai: T1 (8 weeks after baseline)
number of attended sessions / total number of sessions
T1 (8 weeks after baseline)
Dropout rate
Délai: T1 (8 weeks after baseline)
number of dropouts / total number of enrolled participants
T1 (8 weeks after baseline)
Dropout reasons
Délai: T1 (8 weeks after baseline)
structured categories and free text
T1 (8 weeks after baseline)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)
Délai: T0 (baseline), T1 (8 weeks after baseline)
Questionnaire, consisting of 10 items, rated on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true)
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).
Délai: T0 (baseline), T1 (8 weeks after baseline)
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.
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)
Délai: T0 (baseline), T1 (8 weeks after baseline)
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.
T0 (baseline), T1 (8 weeks after baseline)
Change in Perceived Competence, measured by adapted PCS (Perceived Competence Scale, Williams & Deci, 1996)
Délai: T0 (baseline), T1 (8 weeks after baseline)
Questionnaire consisting of 16 items (4 per module) rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)
T0 (baseline), T1 (8 weeks after baseline)
Change in Knowledge concerning therapy content, measured by a self-constructed Multiple Choice Questionnaire
Délai: T0 (baseline), T1 (8 weeks after baseline)
16 multiple choice questions (4 per module), each offering 4 response options with one correct answer
T0 (baseline), T1 (8 weeks after baseline)
Satisfaction, measured by Group Therapy Satisfaction scale (adapted from Westermann et al. 1996)
Délai: T1 (8 weeks after baseline)
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).
T1 (8 weeks after baseline)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
General Feedback, measured by open-ended questions, self-constructed
Délai: T1 (8 weeks after baseline)
Questionnaire consisting of 3 open-ended free-text questions
T1 (8 weeks after baseline)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Max-Planck-Institute of Psychiatry

Les enquêteurs

  • Chercheur principal: Natan Yusupov, MD, PhD, Max-Planck-Institute of Psychiatry
  • Chercheur principal: Angelika Erhardt, MD, Prof., Max-Planck-Institute of Psychiatry
  • Chercheur principal: Peter Falkai, MD, Prof., Max-Planck-Institute of Psychiatry

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

3 septembre 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 juin 2027

Dates d'inscription aux études

Première soumission

11 août 2026

Première soumission répondant aux critères de contrôle qualité

14 août 2026

Première publication (Réel)

19 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 26-0478

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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