ACT-group for Stroke Survivors (Pilot Study)

Stroke Clinical Trial

Official title:

Acceptance and Commitment Therapy-based Group Therapy for Mental Health After Stroke - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282029
• Other study ID #: I-2720-0018-0003
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Bielefeld University
• Contact: Simon Ladwig, PhD
• Phone: +49521 106 67533
• Email: simon.ladwig[@]uni-bielefeld.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cerebral Hemorrhage
• Depression
• Depressive Symptoms
• Hemorrhage
• Intracerebral Hemorrhage
• Stress
• Stroke

Intervention

Behavioral:
• Group Therapy
Acceptance and Commitment Therapy based group therapy

Locations

Country	Name	City	State
Germany	University Neuropsychological Outpatient Clinic	Bielefeld

Sponsors (2)

Lead Sponsor	Collaborator
Bielefeld University	Bielefeld Young Researchers' Fund

Country where clinical trial is conducted

Germany, 

References & Publications (8)

Hill G, Hynd N, Price J, Evan S, Moffitt J, Brechin D. Living well with neurological conditions. South Tees Hospitals NHS Fundation Trust. 2017.

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. — View Citation

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. — View Citation

Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the valuing questionnaire (VQ). Journal of Contextual Behavioral Science, 3(3), 164-172.

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. — View Citation

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

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drop-out rate	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
Primary	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.	Until end of last session, presumably 8 weeks
Primary	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.	Until end of last session, presumably 8 weeks
Primary	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.	Before first and after last session (time frame = 8 weeks)
Primary	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.	Until end of last session, presumably 8 weeks
Primary	Group therapy session questionnaire - patients (Zoubek, 2013; Plain German)	Patients rate acceptance for each session and the whole group therapy.	Until end of last session, presumably 8 weeks
Primary	Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German)	Therapists rate acceptance for each session and the whole group therapy.	Until end of last session, presumably 8 weeks
Primary	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.	Before first and after last session, presumably 8 weeks
Primary	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.	Before first and after last session, presumably 8 weeks
Secondary	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.	Before first and after last session, presumably 8 weeks
Secondary	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.	Before first and after last session, presumably 8 weeks
Secondary	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.	Before first and after last session, presumably 8 weeks
Secondary	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.	Before first and after last session, presumably 8 weeks