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Completed

NCT Number: NCT06282029

ACT-group for Stroke Survivors (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.

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Key information

Conditions

Stroke Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Depression Depressive Symptoms Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stress Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Neuropsychological Outpatient Clinic

Bielefeld, 33607, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Therapy

Behavioral

Acceptance and Commitment Therapy based group therapy

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Bielefeld University

Other

Collaborators

  • Bielefeld Young Researchers' Fund

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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