跳至主要内容
临床试验/NCT04592042
NCT04592042已完成1 期

Intervention to Improve Coping With Negative Emotions in Patients With Psychotic Disorders: Feasibility and Efficacy of an Emotion-oriented Cognitive-behavioural Group Intervention ("Feel-Good-Group").

Philipps University Marburg Medical Center1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年1月8日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Goal attainment scale (GAS, Kiresuk & Sherman, 1968)

研究概览

简要总结

The aim of the present single-centered pre-post study is to assess the feasibility and to investigate the putative efficacy of an emotion-oriented group intervention for patients with psychosis. Patients with early psychosis in an inpatient unit receive a manualized group intervention focussing on emotional stability and emotion regulation (8 weekly sessions). Assessment will be performed at pre-therapy, post-therapy (after eight sessions and four weeks) and after a follow-up period of 12 weeks (8 weeks post therapy) and includes personal therapy goals and their realization, psychopathology, social functioning and emotion regulation skills as a putative mediator of change.

详细描述

The aim of the present single-centered pre-post study is to assess the feasibility and to investigate the putative efficacy of an emotion-oriented cognitive-behavioral group intervention for patients with psychosis.

Patients with psychosis in an inpatient unit are informed on the study and written consent is obtained. At start of therapy, psychopathological interviews and self-report questionnaires are performed. Participants are reassessed after the intervention of 8 sessions (approximately 8 weeks) and after a follow-up period of 8 additional weeks).

Patients are enrolled in a manualized group therapy over 8 sessions including 7 modules. In the first session, group rules are obtained and individual therapy goals are elaborated and developed for each patient. In the next seven sessions, in each session a new module is presented to the patient and the skills are trained in training sessions and role plays.

Module 1 informs on emotions and their role in mental health, module 2 informs on techniques/skills in order to cope with negative emotions more generally. In module 3, mindfulness is presented as a technique to reduce the impact of negative emotions on the patients' life and practised. In module 4, patients learn skills on how to reduce their vulnerability for negative emotions in general. In Module 5, patients learn skills on how to cope with anger, Module 6 teaches skills on how to cope with guilt and shame, Module 7 is presented in the last session and includes skills on how to improve general emotional stability and to prevent relapse.

Training: Therapists are psychologists or psychiatrists that are currently in postgraduate training of Cognitive Behavior Therapy and received 8 sessions of additional training by the study PI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

no masking

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder, bipolar disorder with psychotic symptoms using the International Classification of Diseases-10 (ICD-10 (Codes: F 20.x, F21.x, F22.x, F 23.x, F 25, F30.x, F 31.x ) verified by the Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders 5-Clinical Version (SCID-5-CV) Beesdo-Baum et al., 2019) transformed to ICD-
  • •first psychotic episode in the last five years
  • •written informed consent provided by patient or legal guardian
  • •estimated verbal intelligence of at least 80 IQ-scores estimated with the German Mehrfachwahlwortschatztest (MWT-B, Lehrl et al., 2005)

排除标准

  • •acute suicidality
  • •diagnosis of dementia (verified by the SCID-5-CV interview and patient documentation)

研究组 & 干预措施

Feel-Good-Group

Experimental

Pre-post assessment of feasibility and putative efficacy of an emotion-oriented cognitive-behavioral group intervention over 8 sessions and four weeks.

干预措施: Feel-Good- Group (Behavioral)

结局指标

主要结局

Goal attainment scale (GAS, Kiresuk & Sherman, 1968)

时间窗: Change between start of therapy and end of therapy (approximately 8 weeks).

Patients select in an individual session with their therapist their most important therapy goal and mark on a scale from 0-100, whether it is reached at the present day. The mean score will be used (range between 0 and 100 with higher scores indicating higher values)

Positive and Negative Scale Total score (Kay et al., 1992)

时间窗: Change between start of therapy and end of therapy (approximately 8 weeks).

Interview to assess positive symptoms, negative symptoms and general psychopathology in the last week. Range 30-210 with higher scores indicating more pronounced distress.

次要结局

  • Psychotic Symptoms Rating Scale delusions subscale (PSYRATS, Haddock et al., 1999)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Calgary Depression Scale for Schizophrenia (CDSS; Mueller et al., 1999)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Peters et al, Delusions Inventory (PDI; Lincoln, Keller & Rief, 2009)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Role Functioning Scale (RFS; Goodman et al., 1999)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Paranoia checklist (Freeman et al., 2005)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Emotion Regulation Skills Questionnaire (ERSQ; Berking & Znoj, 2008)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Emotion Regulation Questionnaire (ERQ; Gross & John, 2003)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Emotion Regulation Inventory (ERI; Koenig, 2011)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Rosenberg Self-Esteem Scale (RSE; Collani & Herzberg, 2003)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Beliefs About Stress Scale (BASS; Laferton et al., 2016)(Change between start of therapy and end of therapy (approximately 8 weeks).)
  • Feasibility and acceptance of therapy (Lincoln et al., 2012)(Change between start of therapy and end of therapy(approximately 8 weeks).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Stephanie Mehl

Principal Investigator, Managing Psychologist

Philipps University Marburg Medical Center

研究点 (1)

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