Clinical trial NCT06282029: ACT-group for Stroke Survivors (Pilot Study)
Official title: Acceptance and Commitment Therapy-based Group Therapy for Mental Health After Stroke - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Intracerebral Hemorrhage
Depressive Symptoms
Anxiety
Stress
Keywords: Acceptance and Commitment Therapy
Group therapy
Pilot study
Feasibility
Lead sponsor: Bielefeld University
Sponsor class: OTHER
Collaborators: name: Bielefeld Young Researchers' Fund
First posted: 2024-02-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot study includes a pre-/post test of a small intervention sample without control group.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Drop-out rate
timeFrame: Until end of last session, presumably 8 weeks
measure: Session adherence
timeFrame: Until end of last session, presumably 8 weeks
measure: Homework completion
timeFrame: Until end of last session, presumably 8 weeks
measure: Completion of outcome measures
timeFrame: Before first and after last session (time frame = 8 weeks)
measure: Treatment fidelity
timeFrame: Until end of last session, presumably 8 weeks
measure: Group therapy session questionnaire - patients (Zoubek, 2013; Plain German)
timeFrame: Until end of last session, presumably 8 weeks
measure: Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German)
timeFrame: Until end of last session, presumably 8 weeks
measure: Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German)
timeFrame: Before first and after last session, presumably 8 weeks
measure: Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German)
timeFrame: Before first and after last session, presumably 8 weeks
Secondary outcomes:
measure: Valuing Questionnaire (Smout, 2014; Plain German)
timeFrame: Before first and after last session, presumably 8 weeks
measure: Self-as-context scale (Zettle, 2018; Plain German)
timeFrame: Before first and after last session, presumably 8 weeks
measure: Patient Health Questionnaire-9 (Kroenke, 2001; Plain German)
timeFrame: Before first and after last session, presumably 8 weeks
measure: Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German)
timeFrame: Before first and after last session, presumably 8 weeks
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: University Neuropsychological Outpatient Clinic
Study officials:
affiliation: Bielefeld University
name: Simon Ladwig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hill G, Hynd N, Price J, Evan S, Moffitt J, Brechin D. Living well with neurological conditions. South Tees Hospitals NHS Fundation Trust. 2017.
citation: 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.
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
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.
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.
citation: 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
citation: 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.
citation: 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.