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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Acceptance and Commitment Therapy based group therapy
University Neuropsychological Outpatient Clinic
Bielefeld, Germany
Drop-out rate
Rate of participants discontinuing the group therapy ≤ 20% in each group. Drop-out rate is one indicator of feasibility.
Time frame: Until end of last session, presumably 8 weeks
Session adherence
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.
Time frame: Until end of last session, presumably 8 weeks
Homework completion
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.
Time frame: Until end of last session, presumably 8 weeks
Completion of outcome measures
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.
Time frame: Before first and after last session (time frame = 8 weeks)
Treatment fidelity
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.
Time frame: Until end of last session, presumably 8 weeks
Group therapy session questionnaire - patients (Zoubek, 2013; Plain German)
Patients rate acceptance for each session and the whole group therapy.
Time frame: Until end of last session, presumably 8 weeks
Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German)
Therapists rate acceptance for each session and the whole group therapy.
Time frame: Until end of last session, presumably 8 weeks
Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German)
Measure of psychological flexibility to investigate efficacy. Scores range from 0 to 36 with higher values indicating higher inflexibility.
Time frame: Before first and after last session, presumably 8 weeks
Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German)
Measure of psychological burden to investigate efficacy. Scores range from 0 to 63 with higher values indicating higher burden.
Time frame: Before first and after last session, presumably 8 weeks
Valuing Questionnaire (Smout, 2014; Plain German)
Measure of valued living to investigate efficacy. Scores range from 0 to 60 with higher values indicating higher value-congruent living.
Time frame: Before first and after last session, presumably 8 weeks
Self-as-context scale (Zettle, 2018; Plain German)
Measure of self as context to investigate efficacy. Scores range from 10 to 70 with higher values indicating a perspective closer to self-as-context.
Time frame: Before first and after last session, presumably 8 weeks
Patient Health Questionnaire-9 (Kroenke, 2001; Plain German)
Measure of depressive symptoms to investigate efficacy. Scores range from 0 to 27 with higher values indicating more severe depressive symptoms.
Time frame: Before first and after last session, presumably 8 weeks
Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German)
Measure of anxiety symptoms to investigate efficacy. Scores range from 0 to 21 with higher values indicating more severe anxiety symptoms.
Time frame: Before first and after last session, presumably 8 weeks
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