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StrokeNCT06282029

ACT-group for Stroke Survivors (Pilot Study)

A study testing Group Therapy in people with Stroke and Intracerebral Hemorrhage, run by Bielefeld University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Group Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteGermany
Study dates
1 Feb 2024to 11 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Neuropsychological Outpatient Clinic

    Bielefeld, 33607

Other trials in Germany

About this study

Official title: Acceptance and Commitment Therapy-based Group Therapy for Mental Health After Stroke - a 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.

Read the 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.

Being tested
Group Therapy
Keywords
Acceptance and Commitment Therapy, Group therapy, Pilot study, Feasibility
Medical subject headings
Stroke, Cerebral Hemorrhage, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group TherapyBehavioural

    Acceptance and Commitment Therapy based group therapy

Study groups in NCT06282029
Study groupRoleWhat they receive
Intervention armExperimentalGroup therapy
Receives: Behavioral: Group Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drop-out rate

    Rate of participants discontinuing the group therapy ≤ 20% in each group. Drop-out rate is one indicator of feasibility.

    Measured: Until end of last session, presumably 8 weeks

  2. 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.

    Measured: Until end of last session, presumably 8 weeks

  3. 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.

    Measured: Until end of last session, presumably 8 weeks

  4. 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.

    Measured: Before first and after last session (time frame = 8 weeks)

  5. 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.

    Measured: Until end of last session, presumably 8 weeks

  6. Group therapy session questionnaire - patients (Zoubek, 2013; Plain German)

    Patients rate acceptance for each session and the whole group therapy.

    Measured: Until end of last session, presumably 8 weeks

  7. Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German)

    Therapists rate acceptance for each session and the whole group therapy.

    Measured: Until end of last session, presumably 8 weeks

  8. 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.

    Measured: Before first and after last session, presumably 8 weeks

  9. 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.

    Measured: Before first and after last session, presumably 8 weeks

Secondary outcomes (4)

  1. 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.

    Measured: Before first and after last session, presumably 8 weeks

  2. 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.

    Measured: Before first and after last session, presumably 8 weeks

  3. 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.

    Measured: Before first and after last session, presumably 8 weeks

  4. 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.

    Measured: Before first and after last session, presumably 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Feb 2024
  3. Primary completion16 Jul 2024
  4. Study completion11 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This pilot study includes a pre-/post test of a small intervention sample without control group.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282029
Sponsor's protocol ID
I-2720-0018-0003
Status last verified
Aug 2025
First submitted
12 Feb 2024
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

  • 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

  • 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.

    PubMed 7726811

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

  • 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

  • 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.

    PubMed 11556941

  • 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.

    PubMed 16717171

Questions about this trial

What is this clinical trial studying?

A study testing Group Therapy in people with Stroke and Intracerebral Hemorrhage, run by Bielefeld University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drop-out rate (time frame: Until end of last session, presumably 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06282029, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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ACT-group for Stroke Survivors (Pilot Study) | AzTrials