ACT-group for Stroke Survivors (Pilot Study)

NCT06282029 | Completed

• 1 other identifier: I-2720-0018-0003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Intracerebral Hemorrhage; Depressive Symptoms; Anxiety; Stress

Keywords

Acceptance and Commitment Therapy; Group therapy; Pilot study; Feasibility

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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)

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Valuing Questionnaire (Smout, 2014; Plain German)

  Before first and after last session, presumably 8 weeks

• Self-as-context scale (Zettle, 2018; Plain German)

  Before first and after last session, presumably 8 weeks

• Patient Health Questionnaire-9 (Kroenke, 2001; Plain German)

  Before first and after last session, presumably 8 weeks

• Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German)

  Before first and after last session, presumably 8 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

Group therapy

Behavioral: Group Therapy

Interventions

Group Therapy BEHAVIORAL

Acceptance and Commitment Therapy based group therapy

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bielefeld University: lead
• Bielefeld Young Researchers' Fund: collaborator

Study Sites (1)

University Neuropsychological Outpatient Clinic

Bielefeld, 33607, Germany

Location

Related 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage; Depression; Anxiety Disorders

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Simon Ladwig, PhD

  Bielefeld University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This pilot study includes a pre-/post test of a small intervention sample without control group.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 28, 2024
• Study Start: February 1, 2024
• Primary Completion: July 16, 2024
• Study Completion: February 11, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)