- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512388
Acceptance and Commitment Therapy for Post-Stroke Adjustment Via Telerehabilitation
A stroke can affect someone physically and emotionally. There are more than 1.3 million stroke survivors in the UK, so it is important the right support is available.
Acceptance and commitment therapy is a psychological therapy that helps people adjust to new circumstances. Studies have found that it is helpful for people with long-term health conditions such as brain injury, chronic pain, and multiple sclerosis. Therefore, we want to assess if this therapy can help people adjust to life after a stroke.
To assess this, we are looking for adults over 18 who have:
- Had a stroke over three months ago.
- No other neurological illness.
- No severe cognitive or communication difficulties.
- Been discharged from all rehabilitation programmes.
- No severe psychological disorder.
- Not been diagnosed with a major health condition in the last 12 months.
- Access to a device with a camera, an internet connection and private space for video calls.
Participants will:
- Complete a weekly questionnaire for up to seven weeks on acceptance and action.
- Complete a second questionnaire at week 7 on mood, what is important to participants and how the stroke has affected their life.
- Attend an eight-week online group of acceptance and commitment therapy. Sessions are weekly for 90 minutes, including breaks. Participants will repeat the questionnaire.
- Give feedback after therapy ends and repeat the questionnaires.
- Repeat the questionnaires after three and six months. Participants will be reminded to complete the online questionnaires and can take breaks as needed.
At the end of the study, participants will have a debrief call to discuss details of the study.
Participants will get a £10 Amazon gift card to thank them for taking part.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Norwich, United Kingdom
- University of East Anglia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Suffered a stroke over three months ago.
- No other neurological illness.
- Not currently receiving any psychological intervention.
- No severe communication difficulties.
- No severe cognitive impairments.
- No current or historical suicidal ideation/self-harming behaviours.
- Not been diagnosed with major long-term health conditions in the last 12 months (except for stroke or trans-ischaemic attack; TIA)
- Access to a device with a camera, stable internet connection and private space
Exclusion Criteria:
- Had a TIA without the presence of a stroke.
- No current distress around adjusting to the consequences of stroke.
- Distress of a severity that it cannot be managed safely in a group therapy setting.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acceptance and Commitment Therapy
8-week ACT group intervention.
|
8 weeks of Acceptance and Commitment Therapy delivered as a group intervention via telerehabilitation (online, video call).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological flexibility (CompACT-10)
Time Frame: From baseline to end of intervention (13-15 weeks dependent on baseline length allocated).
|
Data collected using self-report measure (CompACT-10).
Questionnaire completed online, via a link.
Data collected weekly during baseline phase (up to 7 weeks) and intervention phase (8 weeks).
|
From baseline to end of intervention (13-15 weeks dependent on baseline length allocated).
|
|
Psychological Flexibility (CompACT-10)
Time Frame: 6 months post-intervention.
|
Data collected using self-report measure (CompACT-10).
Questionnaire completed online, via a link.
Data collected 6 months after intervention ends.
|
6 months post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Flexibility (CompACT-10)
Time Frame: 3 months post-intervention.
|
Data collected using self-report measure (CompACT-10).
Questionnaire completed online, via a link.
Data collected 3 months after intervention ends.
|
3 months post-intervention.
|
|
Psychological Distress (CORE-10)
Time Frame: Start of intervention and 8 weeks later (after intervention ends)
|
Data collected using self-report measure (CORE-10).
Questionnaire completed online, via a link.
Data collected immediately before and after intervention.
|
Start of intervention and 8 weeks later (after intervention ends)
|
|
Psychological Distress (CORE-10)
Time Frame: 3 months post-intervention
|
Data collected using self-report measure (CORE-10).
Questionnaire completed online, via a link.
Data collected 3 months after intervention ends.
|
3 months post-intervention
|
|
Psychological Distress (CORE-10)
Time Frame: 6 months post-intervention
|
Data collected using self-report measure (CORE-10).
Questionnaire completed online, via a link.
Data collected 6 months after intervention ends.
|
6 months post-intervention
|
|
Stroke Specific Quality of Life (SSQoL-12)
Time Frame: Start of intervention and post 8-week intervention.
|
Data collected using self-report measure (SSQoL-12).
Questionnaire completed online, via a link.
Data collected immediately before and after 8 week intervention.
|
Start of intervention and post 8-week intervention.
|
|
Stroke Specific Quality of Life (SSQoL-12)
Time Frame: 3 months post-intervention
|
Data collected using self-report measure (SSQoL-12).
Questionnaire completed online, via a link.
Data collected 3 months post-intervention.
|
3 months post-intervention
|
|
Stroke Specific Quality of Life (SSQoL-12)
Time Frame: 6 months post-intervention
|
Data collected using self-report measure (SSQoL-12).
Questionnaire completed online, via a link.
Data collected 6 months post-intervention.
|
6 months post-intervention
|
|
Independence/Participation (CIQ-15)
Time Frame: 3 months post-intervention
|
Data collected using self-report measure (CIQ-15).
Questionnaire completed online, via a link.
Data collected 3 months post-intervention.
|
3 months post-intervention
|
|
Independence/Participation (CIQ-15)
Time Frame: 6 months post-intervention
|
Data collected using self-report measure (CIQ-15).
Questionnaire completed online, via a link.
Data collected 6 months post-intervention.
|
6 months post-intervention
|
|
Independence/Participation (CIQ-15)
Time Frame: 8 weeks (before and after intervention).
|
Data collected using self-report measure (CIQ-15).
Questionnaire completed online, via a link.
Data collected immediately before and after 8 week intervention.
|
8 weeks (before and after intervention).
|
|
Wellbeing (SWEMWBS)
Time Frame: 3 months post-intervention
|
Data collected using self-report measure (SWEMWBS).
Questionnaire completed online, via a link.
Data collected 3 months post-intervention.
|
3 months post-intervention
|
|
Wellbeing (SWEMWBS)
Time Frame: 6 months post-intervention
|
Data collected using self-report measure (SWEMWBS).
Questionnaire completed online, via a link.
Data collected 6 months post-intervention.
|
6 months post-intervention
|
|
Wellbeing (SWEMWBS)
Time Frame: 8 weeks (before and after intervention)
|
Data collected using self-report measure (SWEMWBS).
Questionnaire completed online, via a link.
Data collected immediately before and after 8 week intervention.
|
8 weeks (before and after intervention)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 348067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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