ACT-group for Stroke Survivors (Pilot Study)

NCT ID: NCT06282029

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-02-11

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.

Conditions

Stroke; Intracerebral Hemorrhage; Depressive Symptoms; Anxiety; Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention arm

Group therapy

Group Type: EXPERIMENTAL

Group Therapy

Intervention Type: BEHAVIORAL

Acceptance and Commitment Therapy based group therapy

Interventions

Group Therapy

Acceptance and Commitment Therapy based group therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bielefeld Young Researchers' Fund

UNKNOWN

Sponsor Role: collaborator

Bielefeld University

OTHER

Sponsor Role: lead

Responsible Party

Simon Ladwig

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Ladwig, PhD

Role: PRINCIPAL_INVESTIGATOR

Bielefeld University

Locations

University Neuropsychological Outpatient Clinic

Bielefeld, , Germany

Countries

Germany

References

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

Reference Type: 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.

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 7726811 (View on PubMed)

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

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 11556941 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16717171 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

I-2720-0018-0003

Identifier Type: -

Identifier Source: org_study_id