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FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis (FEEL-GOOD)

2026年9月8日 更新者：Stephanie Mehl

Mindfulness-based Group Therapy in Young Inpatients With Acute Early Psychosis (FEEL-GOOD)

FEEL-GOOD is a prospective multi-site single-blinded randomized controlled trial in young inpatients with acute early psychosis. Participants are randomized 1:1 to FEEL-GOOD plus treatment as usual (TAU) or TAU alone. The intervention consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. Outcomes are assessed at baseline, 4 weeks post-intervention, and 6 months follow-up, with the primary outcome being observer-rated total psychopathology as measured with the assessed by the total score of the Positive and Negative Syndrome Scale (PANSS) post-treatment (4 weeks post baseline).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

After providing written informed consent, participants diagnoses will be confirmed with SCID-5-RV interview. The investigator will complete astandardized screening checklist to verify that all inclusion and exclusion criteria are (not) met prior to enrollment in the study. If patients they meet the required inclusion criteria and the exclusion criteria participants will complete baseline data assessment before randomization which will be performed adaptively fromwithin the data management system SecuTrial. Subjects will be randomized in a 1:1 allocation for each study site and will be balanced adaptively for gender and symptom severity as meas-ured by the PANSS total score (3 strata: mild with <54 points, moderate with 54-74 points, and high with >74 points). Participants will further complete two assessments at 4-week and6-month post-intervention. The final assessment for each participant (t3) constitutes the individual end of study participation. As participation is voluntary, participants may withdraw from the study prematurely at any time. Any withdrawal, and the reason for withdrawal will be documented. Reasons for withdrawal may include: 1) withdrawal of consent by participant defined as drop-out (without the need to provide justification), or 2) incorrect inclusion (e.g., subsequent determination of ineligibility).

The FEEL-GOOD trial aims to evaluate a mindfulness-based group therapy for young inpatients with acute early psychosis in addition to treatment as usual (TAU) in comparison to TAU at post-intervention (t2 after 4 weeks) regarding total psychopathology, positive and negative symptoms, and general psychopathology measured with the Positive and Negative Symp-tom Scale (PANSS), as well as acceptance of symptoms, mind- fulness-related and emotion regulation skills in inpatients with EP in comparison to the control group only receiving TAU. The rationale is that early psychosis is a critical treatment window, while current psychological interventions show limited efficacy and low adherence in younger patients; mindfulness-based interventions (MBI) may improve emotional awareness, acceptance, and emotion regulation.

Participants aged 16 to 35 years with early psychosis are recruited across eight German study sites (inpatient hospitals).

FEEL-GOOD is delivered by trained clinical psychologists or psychiatrists and consists of one individual preparatory session and eight modularized 50-minute group sessions over four weeks. Clinical psychologists or psychiatrists will conduct the intervention based on a detailed manual. It will follow the principals of MBI adapted for patients with psychosis. The patients will join the group therapy sessions (open-enrolling group) at any time and then participate at 8 consecutive sessions. Prior to the first group session, there will be an individual session with the study therapist, in which the participants will discuss and write down individual treatment goals related to mindfulness, emotional awareness and emotion regulation.

The core of the intervention will be to provide insights into and to practice the essential elements of mindfulness and emotion regulation: attention to the present moment, as well as non-judgmental awareness and acceptance, and application of emotional awareness and emotion regulation skills. The following modules will be provided: (1) Information on emotions (2 sessions); (2) How to use mindfulness to better cope with distressing emotions and symptoms. (2 sessions); (3) How to reduce vulnerability towards negative emotions (1 session) and (4) Regulation of specific distressing emotions (anger, guild and shame: 2 sessions) and (5) a last session on crisis planning. The intervention was developed in cooperation with Peer Coworkers.

An earlier version of the FEEL-GOOD group intervention was piloted in a feasibility study at Vivantes Hospital Berlin.

Primary Outcome: The primary outcome will be observer-rated (blinded) total psychopathology as measured by the total score of the Positive and Negative Syndrome Scale (PANSS) [post-treatment (4 weeks post baseline).

研究类型

介入性

注册 (估计的)

252

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 德国
    • Baden-Wurttemberg
      • Mannheim、Baden-Wurttemberg、德国、68159
        • 招聘中
        • University of Mannheim, Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, J5, 68169 Mannheim
        • 接触：
        • 首席研究员：
          • Andreas Meyer-Lindenberg, Prof. Dr.
        • 副研究员：
          • Dusan Hirjak, Prof. Dr.
    • Bavaria
      • Augsburg、Bavaria、德国、86156
        • 招聘中
        • University of Augsburg, Department of Psychiatry and Psychotherapy, Geschwister-Schoenert-Str. 1, 86156 Augsburg
        • 接触：
        • 首席研究员：
          • Alkomiet Hasan, Prof. Dr.
      • München、Bavaria、德国、80336
        • 招聘中
        • Ludwig-Maximilians Universität Munich, Department of Psychiatry and Psychotherapy, Nussbaumstr. 7, 80336 Munich
        • 接触：
        • 接触：
        • 首席研究员：
          • Peter Falkai, Prof. Dr.
        • 副研究员：
          • Oliver Pogarell, Prof. Dr.
    • Free and Hanseatic City of Hamburg
      • Hamburg、Free and Hanseatic City of Hamburg、德国、20246
        • 招聘中
        • University of Hamburg, Universitätsklinikum Hamburg-Eppendorf Hamburg, Department of Psychiatry and Psychotherapy
        • 首席研究员：
          • Jürgen Gallinat, Prof. Dr.
        • 接触：
          • Schirin Gellert
          • 电话号码：+49 (0) 40 7410 53210
          • 邮箱：S.Gellert@uke.de
        • 副研究员：
          • Martin Lambert, Prof. Dr.
    • Hesse
      • Marburg、Hesse、德国、35039
        • 招聘中
        • Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Str. 8, 35039 Marburg, Germany
        • 接触：
        • 接触：
        • 首席研究员：
          • Igor Nenadiç, Prof. Dr.
        • 副研究员：
          • Stephanie Mehl, Prof. Dr.
    • North Rhine-Westphalia
      • Cologne、North Rhine-Westphalia、德国、50937
        • 招聘中
        • University of Cologne, Department of Psychiatry and Psychotherapy, Kerpener Str. 62, 50937 Cologne
        • 接触：
        • 接触：
        • 首席研究员：
          • Frank Jessen, Prof. Dr.
        • 副研究员：
          • Joseph Kambeitz, Prof. Dr.
    • State of Berlin
      • Berlin、State of Berlin、德国、10117
        • 招聘中
        • Charité-Universitätsmedizin Berlin (CCM), Department of Psychiatry and Psychotherapy, , Charitéplatz 1, D-10117 Berlin, Germany
        • 接触：
        • 首席研究员：
          • Malek Bajbouj, Prof. Dr.
        • 副研究员：
          • Kerem Böge, Prof. Dr. Dr.
      • Berlin、State of Berlin、德国、10967
        • 招聘中
        • Vivantes Klinikum am Urban, Hospital for Psychiatry, Psychotherapy und Psychosomatics, Dieffenbachstr. 1, 10967 Berlin
        • 接触：
        • 首席研究员：
          • Andreas Bechdolf, Prof. Dr.
        • 副研究员：
          • Anja Lehmann, Dr.
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 16 to 35 years
  • Clinical diagnosis of early psychosis, defined as first psychotic episode within the last 5 years as assessed with the Structural Clinical Interview for DSM-5 Research Version (SCID-5-RV)
  • DSM-5 schizophrenia spectrum or other psychotic disorder confirmed with SCID-5-RV (DSM-5: 297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) Currently receiving inpatient/day clinic treatment with a planned stay of at least 4 weeks
  • Interested in and willing to participate in FEEL-GOOD and/or TAU.

Exclusion Criteria:

  • Insufficient German language abilities
  • Acute suicidality or acute threat to others

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：FEEL-GOOD + TAU
FEEL-GOOD + TAU. FEEL-GOOD consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. The core of the intervention will be to provide insights into and to practice the essential elements of mindfulness and emotion regulation: attention to the present moment, as well as non-judgmental awareness and acceptance, and application of emotional awareness and emotion regulation skills. The following modules will be provided: (1) Information on emotions (2 sessions); (2) How to use mindfulness to better cope with distressing emotions and symptoms. (2 sessions); (3) How to reduce vulnerability towards negative emotions (1 session) and (4) Regulation of specific distressing emotions (anger, guild and shame: 2 sessions) and (5) a last session on crisis planning. Patients additionally receive Treatment as Usual (TAU) as described below.
行为的：FEEL GOOD
FEEL-GOOD consists of one individual preparatory session and eight modularized group sessions delivered over four weeks involving four to eight participants at each session and including practice and homework tasks. The core of the intervention will be to provide insights into and to practice the essential elements of mindfulness and emotion regulation: attention to the present moment, as well as non-judgmental awareness and acceptance, and application of emotional awareness and emotion regulation skills. The following modules will be provided: (1) Information on emotions (2 sessions); (2) How to use mindfulness to better cope with distressing emotions and symptoms. (2 sessions); (3) How to reduce vulnerability towards negative emotions (1 session) and (4) Regulation of specific distressing emotions (anger, guild and shame: 2 sessions) and (5) a last session on crisis planning.
有源比较器：TAU
Participants receive treatment as usual (TAU), consisting of standard inpatient psychiatric care for early psychosis, including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.
其他：Treatment as Usual (TAU)
Standard inpatient psychiatric treatment for early psychosis including pharmacotherapy, supportive counselling, psychotherapeutic group interventions, occupational therapy, physiotherapy, and social work as clinically indicated.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Positive and Negative Symptom Scale Total Score (PANSS; Blinded assessment)
大体时间：Baseline (t1), 4 weeks (t2); additional assessment at 6-months follow-up (t3)
The primary outcome is observer-rated (blinded) total psychopathology as measured by the total score of PANSS after 4 weeks (t2). PANSS is widely used and the gold standard for psychopathological outcomes in people with psychotic disorders. It integrates positive, negative, and general psychopathological symptoms.
Baseline (t1), 4 weeks (t2); additional assessment at 6-months follow-up (t3)

次要结果测量

结果测量
措施说明
大体时间
Positive and negative symptoms, general psychopathology as measured by PANSS Positive, Negative and General Psychopathology subscales (Blinded assessment)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The PANSS is a semi-structured interview to assess positive symptoms (PANSS Positive Scale), negative symptoms (PANSS Negative Scale) and general pathology (PANSS General Psychopathology Scale) of Psychosis.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Five-Facet Mindfulness Questionnaire (FFFM-D) (Self Report, putative mediator)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The FFMQ-D consists of 39 items forming the 5 subscales non-reactivity to inner experience, observing, acting with awareness, describing/labelling with words, and nonjudging of inner experience. Items are self-rated on a 5-point Likert-scale.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Rosenberg Self-Esteem Scale total score (RSES) (Self Report, putative mediator)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Global self-esteem will be assessed with the RSES that consists of 10 items self-rated on a 4-point Likert-scale.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Toronto Alexithymia Scale (TAS-26) (Self Report, putative mediator)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The TAS-26 is the German version of the TASand consists of 26 items with the 3 subscales: Difficulties Identifying Feelings, Difficulties Describing Feelings, and Externally Oriented Thinking self-rated on a 5-point Likert-scale.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Cognitive Emotion Regulation Questionnaire (CERQ) (Self Report, putative mediator)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The CERQ measures cognitive coping strategies, i.e., thoughts after negative events or situations on 9 subscales (self-blame, blaming others, acceptance, refocusing on planning, positive refocusing, rumination, positive reappraisal, putting into perspective, and catastrophizing), each consisting of 4 items that are self-rated on 5-point Likert-scales.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Emotion regulation skills (ERSQ) (Self Report, putative mediator)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The ERSQ consists of 27 items with 9 subscales assessing competencies that are considered essential for successful emotion regulation (i.e., attention, clarity, bodily awareness, understanding, acceptance, resilience, self-support, willingness to confront, and regulation). Self-reports are rated on a 5-point Likert-scale.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Patient satisfaction questionnaire (ZUF) (Self Report, putative mediator)
大体时间：4 weeks (t2), 6 months follow-up (t3)
The ZUF-8 is the German version adapted for inpatients based on the Client Satisfaction Questionnaire (CSQ-8). It consists of 8 items self-rated on a 4-point Likert-scale and assesses patients' overall satisfaction with the clinical treatment received.
4 weeks (t2), 6 months follow-up (t3)
World Health Organization Quality of Life - 100 item version (WHOQOL-BREF) (Self Report, putative mediator)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The WHOQOL-BREF assesses quality of life as a subjective evaluation, embedded within the individual's cultural, social, and environmental context using 26 items divided into 4 domains: physical health, psychological well-being, social relationships, and environment. Items are rated on a 5-point Likert-scale.
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Psychotic Symptom Rating Scales to assess delusions (PSYRATS-D) and hallucinations (PSYRATS-H) (Blinded assessment)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The PSYRATS is a semi-structured interview to assess delusions and hallucinations. It consist of 17 items assessing specific dimensions of hallucinations and delusions. Each item is observer-rated on a 5-point scale ranging from 0 (= absent) to 4 (=severe). The PSYRATS include two subscales: hallucinations with 11 items (PSYRATS-H) and delusions with 6 items (PSYRATS-D).
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Depressive symptoms using the Calgary Depression Scale for Schizophrenia (CDSS) (Blinded asessment)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The CDSS is considered as the gold standard to assess depression specifically in people with schizophrenia spectrum disorders. The 9 items are observer-rated on a scale ranging from 0 (=absent) to 3 (=severe). It distinguishes between depressive symptoms, positive, negative, and extrapyramidal symptoms in adolescents and adults
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Role Functioning Scale (RFS) (Blinded assessment)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
The RFS is a semi-structured interview that measures performance on 4 single rating scales: working productivity, independent living, immediate social network relationships (friends and family), and extended social network relationships (other social contacts) with observer ratings from 0 (= minimal functioning) to 12 (= optimal functioning).
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Global Assessment of Functioning (GAF), (Blinded assessment)
大体时间：Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)

In the GAF scale, clinicians rate a patient's overall level of psychological, social, and occupational functioning using a single score ranging from 1 to 100. A score of 100 represents superior functioning, whereas a score of 1 indicates a persistent risk of serious harm to oneself or others, severe impairment in basic self-care, or a suicidal act with clear expectation of death.

Changes of approximately 4, 10, or 12 points have been suggested to represent clinically meaningful differences [15].
Baseline (t1), 4 weeks (t2), 6 months follow-up (t3)
Serious adverse events (SAEs) (Blinded Assessment)
大体时间：Continuously during intervention and follow-up
Serious adverse events are assessed and consist of suicidality, suicide attempts, death, life-threatening events or hospitalization (if patients were previously in outpatient treatment).
Continuously during intervention and follow-up
Ecological Momentary Assessment (EMA) (Self Report, putative mediator)
大体时间：Starting at t1, EMA is assessed once a day during the intervention period including 7 days post t2-assessment at four weeks.
Participants will complete EMA via the m-Path mobile application starting after giving informed consent and randomisation into the trial and will end seven days post-intervention. There will be one prompt per day. Each prompt will include approximately 39-46 items, depending on conditional branching. The questions will cover several domains, such as current emotional state, psychopathological symptoms, mindfulness, emotional (in-)stability, and emotion regulation skills.
Starting at t1, EMA is assessed once a day during the intervention period including 7 days post t2-assessment at four weeks.

其他结果措施

结果测量
措施说明
大体时间
Childhood Trauma Questionnaire (CTQ) (Self Report)
大体时间：Baseline (t1)
The self-rating questionnaire Child Trauma Questionnaire (CTQ) consists of five subscales: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect, each comprising five items, and an additional minimization/denial scale consisting of 3 items. Items are rated on a 5-point Likert-Scale.
Baseline (t1)
Cognitive Therapy Scale Revised for Psychosis (CTS-R-P)
大体时间：During the intervention period (4 weeks)
The Cognitive Therapy Scale Revised for Psychosis (CTS-R-P) is used as an adapted version to assess video or audio recordings of the group intervention and the preparatory session to evaluate adherence to cognitive therapy principles and the overall competence of therapists delivering the intervention. A random selection of 25% of all recordings are assessed.
During the intervention period (4 weeks)
Mindfulness-Based Cognitive Therapy Adherence Scale (MBCT-AS)
大体时间：During the intervention period (4 weeks).
Recordings of the group sessions are rated using the MBCT-AS in order to to assess how closely therapists adhere to the core principles and procedures of Mindfulness-Based Cognitive Therapy. A random selection of 25% of all recordings are assessed.
During the intervention period (4 weeks).
Structured Clinical Interview for DSM-5 (Research Version)
大体时间：Baseline (t1)
Diagnoses are confirmed using the structured interview SCID-5-RV. The SCID is an interview designed to systematically assess DSM-5 mental disorders for research purposes.
Baseline (t1)
Assessment of withdrawal and reasons for withdrawal
大体时间：During the intervention and at 6-months follow-up (T3)
Any withdrawal, and the reason for withdrawal will be documented. Reasons for withdrawal may include: 1) withdrawal of consent by participant defined as drop-out (without the need to provide justification), or 2) incorrect inclusion (e.g., subsequent determination of ineligibility).
During the intervention and at 6-months follow-up (T3)
Assessment of Sociodemographic and Clinical Variables
大体时间：Baseline (t1), 4 weeks (t2) and 6-months follow-up (t3)
Socio-demographic data will be collected by raters at baseline to describe the study population. Core variables include age, gender, education, migration background, residential status and employment status. Clinical variables include the number of previous hospitalisations and outpatient treatments, medication and duration of illness. Medication, hospitalisations and additional treatments will be assessed additionally post-intervention and at 6-months follow-up.
Baseline (t1), 4 weeks (t2) and 6-months follow-up (t3)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stephanie Mehl

合作者

German Research Foundation
Charite University, Berlin, Germany
University of Cologne
Ludwig-Maximilians - University of Munich
Universitätsklinikum Hamburg-Eppendorf
Central Institute of Mental Health, Mannheim
University Hospital Augsburg
Vivantes Klinikum am Urban
Philipps University Marburg

调查人员

  • 首席研究员：Andreas Bechdolf, Prof. Dr.、Department of Psychiatry and Psychotherapy, CCM, Charité-Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin, Germany
  • 学习椅：Stephanie Mehl, Prof. Dr.、Marburg University, Department of Psychiatry and Psychotherapy, Rudolf-Bultmann-Strasse 8,35039 Marburg, Germany

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月27日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年5月16日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BE 3967/5-1 (其他标识符：German Research Foundation (DFG))
  • EA2/287/25 (其他标识符：Ethics Commission Charité Berlin)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Patients will not be asked whether they consent to individual data sharing. It might be possible to share some individual anonymized data based on agreement of the Data Protection Official of each individual study site.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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