- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06282029
ACT-group for Stroke Survivors (Pilot Study)
February 20, 2024 updated by: Simon Ladwig, Bielefeld University
Acceptance and Commitment Therapy-based Group Therapy for Mental Health After Stroke - a Pilot Study
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Simon Ladwig, PhD
- Phone Number: +49521 106 67533
- Email: simon.ladwig@uni-bielefeld.de
Study Locations
-
-
-
Bielefeld, Germany, 33607
- Recruiting
- University Neuropsychological Outpatient Clinic
-
Contact:
- Simon Ladwig, PhD
- Phone Number: 017664716035
- Email: simon.ladwig@uni-bielefeld.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Time since stroke > 3 months and < 2 years.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
Group therapy
|
Acceptance and Commitment Therapy based group therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Until end of last session, presumably 8 weeks
|
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.
|
Until end of last session, presumably 8 weeks
|
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.
|
Until end of last session, presumably 8 weeks
|
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.
|
Before first and after last session (time frame = 8 weeks)
|
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.
|
Until end of last session, presumably 8 weeks
|
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.
|
Until end of last session, presumably 8 weeks
|
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.
|
Until end of last session, presumably 8 weeks
|
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.
|
Before first and after last session, presumably 8 weeks
|
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.
|
Before first and after last session, presumably 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Valuing Questionnaire (Smout, 2014; Plain German)
Time Frame: 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.
|
Before first and after last session, presumably 8 weeks
|
Self-as-context scale (Zettle, 2018; Plain German)
Time Frame: 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.
|
Before first and after last session, presumably 8 weeks
|
Patient Health Questionnaire-9 (Kroenke, 2001; Plain German)
Time Frame: 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.
|
Before first and after last session, presumably 8 weeks
|
Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German)
Time Frame: 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.
|
Before first and after last session, presumably 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Simon Ladwig, PhD, Bielefeld University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the valuing questionnaire (VQ). Journal of Contextual Behavioral Science, 3(3), 164-172.
- Hill G, Hynd N, Price J, Evan S, Moffitt J, Brechin D. Living well with neurological conditions. South Tees Hospitals NHS Fundation Trust. 2017.
- Zoubek, K. (2013). Prozessevaluation einer kognitiv-verhaltenstherapeutischen Gruppentherapie bei Diabetes und Depression: Entwicklung und Validierung der Patienten- und Therapeuten-Gruppentherapiestundenbögen (GTS-P, GTS-T, GTS-TP) zur Vorhersage des Therapieerfolgs. [Dissertation, Johannes Gutenberg-Universität Mainz]. OpenScience JGU Mainz.
- Sylvester, M. (2011). Acceptance and Commitment Therapy for improving adaptive functioning in persons with a history of pediatric acquired brain injury. [Doctoral dissertation, University of Nevada]. ProQuest
- Zettle, R. D., Gird, S. R., Webster, B. K., Carrasquillo-Richardson, N., Swails, J. A., & Burdsal,C. A. (2018). The Self-as-Context Scale: Development and preliminary psychometric properties. Journal of Contextual Behavioral Science, 10, 64-74
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
February 12, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Estimated)
February 28, 2024
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-2720-0018-0003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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