Acceptance and Commitment Therapy-based Group Therapy for Mental Health After Stroke - a Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Bielefeld University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Treatment fidelity
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Simon Ladwig
Principal Investigator
Bielefeld University
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Treatment fidelity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)