Evaluation of a Modularized Cognitive Behavioral Group Therapy Programme for Young Adults (CHANGE-Study) (CHANGE)
2026年8月14日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Natan Yusupov, MD, PhD
- 電話番号：0049-89-30622-8338
- メール：natan_yusupov@psych.mpg.de
研究場所
-
-
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Munich、ドイツ、80804
- Max-Planck-Institute of Psychiatry
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コンタクト：
- Peter Falkai, MD, Prof.
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of CHANGE group therapy programme, measured by adapted SMI (a German scale for feasibility, Weiner et al. 2017)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in self-efficacy, measured by SWE (a German scale for generalized self-efficacy, Schwarzer & Jerusalem, 2003)
時間枠：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).
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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General Feedback, measured by open-ended questions, self-constructed
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Natan Yusupov, MD, PhD、Max-Planck-Institute of Psychiatry
- 主任研究者：Angelika Erhardt, MD, Prof.、Max-Planck-Institute of Psychiatry
- 主任研究者：Peter Falkai, MD, Prof.、Max-Planck-Institute of Psychiatry
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月3日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年8月11日
QC基準を満たした最初の提出物
2026年8月14日
最初の投稿 (実際)
2026年8月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月14日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 26-0478
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