Stroke Clinical Trial
Official title:
A Randomised Waiting List Controlled Study of Group Based Acceptance and Commitment Therapy (ACT) to Promote Psychological Wellbeing in People Living With the Consequences of Stroke or Acquired Brain Injury
NCT number | NCT04995705 |
Other study ID # | 259095 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | April 8, 2019 |
Est. completion date | March 23, 2020 |
Verified date | July 2021 |
Source | Aneurin Bevan University Health Board |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stroke and Acquired Brain Injury (ABI) represent a major cause of long-term disability among survivors. Many psychological difficulties can also occur including: depression, anxiety, fatigue, and post-traumatic stress disorder. This has a marked impact on health service usage. Despite certain interventions being offered to support stroke survivors and individuals with brain injury, there is still an outstanding need to increase and improve psychological resources for this population. This research proposes to evaluate the effectiveness of a group therapy intervention, using a model called Acceptance and Commitment Therapy (ACT), for stroke survivors and adults with ABI. This ACT group aims to promote positive adjustment and improve wellbeing, whilst also aiming to reduce levels of distress. The research will comprise of two parts (one quantitative and the other qualitative).
Status | Terminated |
Enrollment | 39 |
Est. completion date | March 23, 2020 |
Est. primary completion date | March 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All participants must be 18 years of age or older. - Participants must have a clinical diagnosis of stroke or brain injury - Must be able to understand English and communicate responses - The target participant has been referred to the adapted ACT group by a clinician, stroke association co-ordinator or senior Headway professional. - Participants with a mild to moderate level of psychological need - Participants must be capable of giving informed consent Exclusion Criteria: - Candidates with significant cognitive/language/behavioural impairment that would prevent them from engaging with the group - Candidates with a diagnosed degenerative condition (e.g. dementia). (NB candidates with a brain tumour diagnosis who are currently stable will be eligible.) - Candidates experiencing severe/active psychotic symptoms - Candidates with a high level of psychological need that would be better met through a more intensive intervention - Candidates receiving other therapies, as part of a multi-component intervention that would prevent any changes specific to the group psychotherapy to be estimated (except drugs for depression and anxiety) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aneurin Bevan University Health Board | Newport | Wales |
Lead Sponsor | Collaborator |
---|---|
Anna Pennington | Aneurin Bevan University Health Board, Stroke Implementation Group, Swansea Bay University Health Board |
United Kingdom,
Evans, C., Mellor-Clark, J., Margison, F., Barkham, M., Audin, K., Connell, J., & McGrath, G. (2000). CORE: Clinical Outcomes in Routine Evaluation. Journal of Mental Health, 9(3), 247-255
Fleminger S, Ponsford J. Long term outcome after traumatic brain injury. BMJ. 2005 Dec 17;331(7530):1419-20. — View Citation
Francis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. (2016). The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science, 5(3), 134-145. https://doi.org/10.1016/j.jcbs.2016.05.003
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Lincoln, N. B., Kneebone, I. I., Macniven, J. A., & Morris, R. C. (2012). Psychological management of stroke. John Wiley & Sons.
Naylor, C., Parsonage, M., McDaid, D., Knapp, M., Fossey, M. & Galea, A. (2012). Long-term conditions and mental health: the cost of co-morbidities. The King's Fund, London, UK.
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) | Exploring change in this measure of psychological flexibility | Pre (Baseline); Post (5 weeks); Follow Up (10 weeks) | |
Primary | Dispositional or Adult Hope Scale | Exploring change in this scale which assesses a person's global level of dispositional or trait hope. | Pre (Baseline); Post (5 weeks); Follow Up (10 weeks) | |
Primary | Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) | Exploring change CORE-OM, which measures levels of global distress | Pre (Baseline); Post (5 weeks); Follow Up (10 weeks) | |
Primary | Euro-Qol: EQ-5D-5L | Exploring change in this scale which measures health-related quality of life. | Pre (Baseline); Post (5 weeks); Follow Up (10 weeks) |
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