Acceptance and Commitment Therapy-based Group Therapy for Mental Health After Stroke - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Treatment fidelity
研究概览
简要总结
The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are:
- Is the group therapy feasible?
- Is the group therapy accepted by stroke survivors and therapists?
- Are there first indications on the efficacy of the group therapy to improve mental health?
Participants will take part in 8 weekly group therapy sessions of 90 minutes each.
详细描述
This trail aims to investigate the feasibility, acceptance and preliminary efficacy of a group therapy manual based on Acceptance and Commitment Therapy. The manual is an adaptation of "Living Well with Neurological Conditions" (Hill et al., 2017), which was conducted in groups with acquired brain injury in general. The manual was translated to German and adapted to the needs of stroke survivors who are often older, have more comorbidities and specific neurological impairments. Session length was reduced from 165 minutes to 90 minutes. The program includes 8 weekly sessions. In addition, outcome questionnaires were translated to German and all measures are translated into plain language to increase accessibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Value above a cut-off on one 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)
- •Parallel psychotherapy or neuropsychological therapy
结局指标
主要结局
Treatment fidelity
时间窗: Until end of last session, presumably 8 weeks
Treatment fidelity ≥ 80% in each group. Two randomly selected sessions are video-recorded. A research assistant then applies self-developed checklists for the respective sessions to assess if therapists adhere to manual instructions and contents. Treatment fidelity is one indicator of feasibility.
Homework completion
时间窗: Until end of last session, presumably 8 weeks
Mean rate of participants completing homework ≥ 50% in each group. Mean rate of participants attending sessions ≥ 80% in each group. Homework completion is assessed each session and averaged over all 8 sessions. Homework completion is one indicator of feasibility.
Drop-out rate
时间窗: Until end of last session, presumably 8 weeks
Rate of participants discontinuing the group therapy ≤ 20% in each group. Drop-out rate is one indicator of feasibility.
Session adherence
时间窗: Until end of last session, presumably 8 weeks
Mean rate of participants attending sessions ≥ 80% in each group. Attendance is assessed each session and averaged over all 8 sessions. Session adherence is one indicator of feasibility.
Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German)
时间窗: Until end of last session, presumably 8 weeks
Therapists rate acceptance for each session and the whole group therapy.
Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German)
时间窗: Before first and after last session, presumably 8 weeks
Measure of psychological flexibility to investigate efficacy. Scores range from 0 to 36 with higher values indicating higher inflexibility.
Completion of outcome measures
时间窗: Before first and after last session (time frame = 8 weeks)
Mean rate of completed outcome measures ≥ 80% in each group. Rate is calculated based on number of completed items in all questionnaires. Completion of outcome measures is one indicator of feasibility.
Group therapy session questionnaire - patients (Zoubek, 2013; Plain German)
时间窗: Until end of last session, presumably 8 weeks
Patients rate acceptance for each session and the whole group therapy.
Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German)
时间窗: Before first and after last session, presumably 8 weeks
Measure of psychological burden to investigate efficacy. Scores range from 0 to 63 with higher values indicating higher burden.
次要结局
- Self-as-context scale (Zettle, 2018; Plain German)(Before first and after last session, presumably 8 weeks)
- Patient Health Questionnaire-9 (Kroenke, 2001; Plain German)(Before first and after last session, presumably 8 weeks)
- Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German)(Before first and after last session, presumably 8 weeks)
- Valuing Questionnaire (Smout, 2014; Plain German)(Before first and after last session, presumably 8 weeks)
研究者
Simon Ladwig
Principal Investigator
Bielefeld University