Stroke, Intracerebral Hemorrhage, Depressive Symptoms, Anxiety, Stress
Conditions
Keywords
Acceptance and Commitment Therapy, Group therapy, Pilot study, Feasibility
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.
Interventions
BEHAVIORALGroup Therapy
Acceptance and Commitment Therapy based group therapy
Sponsors
Bielefeld Young Researchers' Fund
Bielefeld University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This pilot study includes a pre-/post test of a small intervention sample without control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German) | 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. |
| Treatment fidelity | 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. |
| Group therapy session questionnaire - patients (Zoubek, 2013; Plain German) | Until end of last session, presumably 8 weeks | Patients rate acceptance for each session and the whole group therapy. |
| Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German) | 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) | 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. |
| Drop-out rate | 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 | 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. |
| Homework completion | 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. |
| Completion of outcome measures | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-as-context scale (Zettle, 2018; Plain German) | Before first and after last session, presumably 8 weeks | 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. |
| Patient Health Questionnaire-9 (Kroenke, 2001; Plain German) | Before first and after last session, presumably 8 weeks | Measure of depressive symptoms to investigate efficacy. Scores range from 0 to 27 with higher values indicating more severe depressive symptoms. |
| Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German) | Before first and after last session, presumably 8 weeks | Measure of anxiety symptoms to investigate efficacy. Scores range from 0 to 21 with higher values indicating more severe anxiety symptoms. |
| Valuing Questionnaire (Smout, 2014; Plain German) | Before first and after last session, presumably 8 weeks | Measure of valued living to investigate efficacy. Scores range from 0 to 60 with higher values indicating higher value-congruent living. |
Countries
Germany
Outcome results
None listed