CompletedNot Applicable

ACT-group for Stroke Survivors (Pilot Study)

Germany10 participantsStarted 2024-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Drop-out rate

Timeframe: Until end of last session, presumably 8 weeks

Session adherence

Timeframe: Until end of last session, presumably 8 weeks

Homework completion

Timeframe: Until end of last session, presumably 8 weeks

Completion of outcome measures

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

Treatment fidelity

Timeframe: Until end of last session, presumably 8 weeks

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

Timeframe: Until end of last session, presumably 8 weeks

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

Timeframe: Until end of last session, presumably 8 weeks

Trial details

NCT IDNCT06282029

SponsorBielefeld University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-16

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Drop-out rate

Timeframe: Until end of last session, presumably 8 weeks

Session adherence

Timeframe: Until end of last session, presumably 8 weeks

Homework completion

Timeframe: Until end of last session, presumably 8 weeks

Completion of outcome measures

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

Treatment fidelity

Timeframe: Until end of last session, presumably 8 weeks

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

Timeframe: Until end of last session, presumably 8 weeks

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

Timeframe: Until end of last session, presumably 8 weeks