- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02584101
Acceptance and Commitment Therapy (ACT) and Carers
The Use of Acceptance and Commitment Therapy to Promote WellBeing and Psychological Flexibility in Carers: A Randomized Controlled Feasibility Trial
Background: Research has extensively documented the adverse impact that caring for an individual with an acquired brain injury can have including financial difficulties, social isolation, family tension and conflict, relationship difficulties, role adjustment and psychological distress (Foster et al., 2012). Research has indicated that Acceptance and Commitment Therapy (ACT) shows promise for increasing wellbeing and psychological flexibility in caregivers and could be a useful intervention for use with this population.
Aims: The primary aim of this study is to investigate the feasibility of using an ACT intervention to enhance the wellbeing and the psychological flexibility of carers using the Population, Intervention, Control, and Outcomes (PICO) framework. Methods: The current study is a randomised control design, exploring the feasibility of comparing the efficacy of an ACT intervention to Enhanced Treatment As Usual (ETAU), to improve the wellbeing of the carers of adults with an acquired brain injury (ABI). Participants will be recruited from the Brain Injury Rehabilitation Trust (BIRT) in Glasgow, Scotland and randomly assigned to either an ACT intervention group or TAU control group. Both will be assessed in parallel to one another completing a range of baseline and post-baseline measures. Applications: This feasibility study will provide information for further research on the utilisation of an ACT intervention to improve the wellbeing of carers and whether this is an acceptable intervention for this population.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Glasgow, United Kingdom
- Brain Injury Rehabilitation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- full time or part time carer for an adult with an acquired brain injury
Exclusion Criteria:
- learning disability
- not proficient in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACT
ACT therapy
|
ACT therapy administered in 3 sessions over a 4 week period
|
|
Active Comparator: Enhanced Treatment as Usual
Group support
|
2 group discussion sessions over a 4 week period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being
Time Frame: 4 weeks
|
Change in General Health Questionnaire (GHQ-12) score
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Flexibility
Time Frame: 4 weeks
|
Change in Acceptance and Action Questionnaire (AAQII) score
|
4 weeks
|
|
Values
Time Frame: 4 weeks
|
Change in Valuing Questionnaire (VQ) score
|
4 weeks
|
|
Experiential Avoidance
Time Frame: 4 weeks
|
Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) score
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ross White, BSc(Hons) PhD DClinPsy, University of Glasgow
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/WS/0208
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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