跳至主要内容
临床试验/NCT06897553
NCT06897553招募中不适用

Acceptance and Commitment Therapy- Based Group Therapy for Mental Health in Neurological Disorders

Bielefeld University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
2
主要终点
Depression and Anxiety Stress Scales-21 (Lovibond, 1995)

研究概览

简要总结

The goal of this clinical trial is to examine the efficacy of this manual for mental health in people with mixed neurological disorders, including post-COVID. These conditions are often associated with cognitive impairment, which may hamper the effects of psychoterapy. Executive functioning and especially the ability to abstract thinking may be useful for individuals using Acceptance and Commitment Therapy. Therefore, the main questions research questions are:

  • Is this intervention effective in improving mental health?
  • Do executive functions predict the extent of social participation and mental health at the end of therapy? Participants will take part in 8 weekly group therapy sessions of 100 minutes each.

详细描述

Mental health issues, especially depression, anxiety, and stress, are common in people with neurological disorders and post-COVID but often neglected and hence, remain untreated. Acceptance and Commitment Therapy (ACT) is a promising approach to assist people in adapting to their conditions by improving "psychological flexibility".

A previous study translated an adapted group psychotherapy manual for stroke survivors into German and demonstrated its feasibility. This pilot study also gave first indications on the manual's efficacy in reducing symptoms of anxiety, depression, and stress. The aim of this study is to investigate the efficacy of this ACT-based group therapy. People with neurological disorders may have impairments in executive functions, which can affect the psychotherapeutic process. Since ACT often uses metaphors and imagery, executive functions, particularly the ability to abstract, could influence the efficacy of the therapy and are therefore being investigated in this study. The program includes 8 weekly sessions with a session length of 100 minutes.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Value above a cut-off of the DASS-21 subscales (depression > 10, anxiety > 6, and stress > 10)
  • Sufficient cognition and language ability (clinical rating)
  • Sufficient therapy motivation (clinical rating)

排除标准

  • Behavioral disorders (e.g., high irritability or apathy in clinical rating)
  • Other severe mental disorder (dementia, psychosis, personality disorders, intellectual disability)
  • Simultaneous psychotherapy or neuropsychological therapy

结局指标

主要结局

Depression and Anxiety Stress Scales-21 (Lovibond, 1995)

时间窗: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)

Measure of psychological burden to investigate efficacy. Scores range from 0 to 63 with higher values indicating higher burden.

Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011)

时间窗: Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart)

Measure of psychological flexibility to investigate efficacy. Scores range from 0 to 36 with higher values indicating higher inflexibility.

Wechsler Adult Intelligence Scale - Fourth Edition (Similarities subtest; Wechsler, 2008)

时间窗: pre- and post-intervention (pre and post are presumably 8 weeks apart)

Measure of individual's ability to recognize and articulate the commonalities between different objects, reflecting their abstraction ability. This will be used to examine the influence of the ability of abstract thinking. Scores range from 0 to 36 with higher values indicating higher ability of abstraction.

次要结局

  • Valuing Questionnaire (Smout, 2014)(Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart))
  • Self-as-context scale (Zettle, 2018)(Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart))
  • World Health Organization Disability Assessment Schedule 2.0 (V.S. Üstün, 2010; Plain German)(Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart))
  • Regensburg Word Fluency Test (Aschenbrenner, 2001)(pre- and post-intervention (pre and post are presumably 8 weeks apart))
  • Stroop Test in Vienna Test System (Müller & Ziegler, 2001)(pre- and post-intervention (pre and post are presumably 8 weeks apart))
  • Patient Health Questionnaire-9 (Kroenke, 2001)(Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart))
  • Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2007)(Before waiting list condition; and pre- and post-intervention (pre and post are presumably 8 weeks apart))

研究者

发起方
Bielefeld University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Ladwig

Research Fellow (Post-Doc)

Bielefeld University

研究点 (2)

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