Acceptance and Commitment Therapy (ACT) and Carers

Brain Injuries Clinical Trial

Official title:

The Use of Acceptance and Commitment Therapy to Promote WellBeing and Psychological Flexibility in Carers: A Randomized Controlled Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584101
• Other study ID #: 15/WS/0208
• Status: Completed
• Phase: N/A
• First received: October 21, 2015
• Last updated: May 25, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Behavioral:
• ACT
ACT therapy administered in 3 sessions over a 4 week period
• Enhanced Treatment as Usual
2 group discussion sessions over a 4 week period

Locations

Country	Name	City	State
United Kingdom	Brain Injury Rehabilitation Trust	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	Brain Injury Rehabilitation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Well-being	Change in General Health Questionnaire (GHQ-12) score	4 weeks	No
Secondary	Psychological Flexibility	Change in Acceptance and Action Questionnaire (AAQII) score	4 weeks	No
Secondary	Values	Change in Valuing Questionnaire (VQ) score	4 weeks	No
Secondary	Experiential Avoidance	Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) score	4 weeks	No