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Acceptance and Commitment Therapy (ACT) and Carers

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ACT
Enhanced Treatment as Usual
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Acceptance and Commitment Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • full time or part time carer for an adult with an acquired brain injury

Exclusion Criteria:

  • learning disability
  • not proficient in English

Sites / Locations

  • Brain Injury Rehabilitation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACT

Enhanced Treatment as Usual

Arm Description

ACT therapy

Group support

Outcomes

Primary Outcome Measures

Well-being
Change in General Health Questionnaire (GHQ-12) score

Secondary Outcome Measures

Psychological Flexibility
Change in Acceptance and Action Questionnaire (AAQII) score
Values
Change in Valuing Questionnaire (VQ) score
Experiential Avoidance
Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) score

Full Information

First Posted
October 21, 2015
Last Updated
May 25, 2016
Sponsor
University of Glasgow
Collaborators
Brain Injury Rehabilitation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02584101
Brief Title
Acceptance and Commitment Therapy (ACT) and Carers
Official Title
The Use of Acceptance and Commitment Therapy to Promote WellBeing and Psychological Flexibility in Carers: A Randomized Controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
Brain Injury Rehabilitation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
Acceptance and Commitment Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT
Arm Type
Experimental
Arm Description
ACT therapy
Arm Title
Enhanced Treatment as Usual
Arm Type
Active Comparator
Arm Description
Group support
Intervention Type
Behavioral
Intervention Name(s)
ACT
Intervention Description
ACT therapy administered in 3 sessions over a 4 week period
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment as Usual
Intervention Description
2 group discussion sessions over a 4 week period
Primary Outcome Measure Information:
Title
Well-being
Description
Change in General Health Questionnaire (GHQ-12) score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Psychological Flexibility
Description
Change in Acceptance and Action Questionnaire (AAQII) score
Time Frame
4 weeks
Title
Values
Description
Change in Valuing Questionnaire (VQ) score
Time Frame
4 weeks
Title
Experiential Avoidance
Description
Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) score
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: full time or part time carer for an adult with an acquired brain injury Exclusion Criteria: learning disability not proficient in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross White, BSc(Hons) PhD DClinPsy
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Injury Rehabilitation Trust
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

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Acceptance and Commitment Therapy (ACT) and Carers

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