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Completed

NCT Number: NCT02584101

Acceptance and Commitment Therapy (ACT) and Carers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Injury Rehabilitation Trust

Glasgow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • learning disability
  • not proficient in English

Treatment and study plan

ACT

Behavioral

ACT therapy administered in 3 sessions over a 4 week period

Enhanced Treatment as Usual

Behavioral

2 group discussion sessions over a 4 week period

Primary outcomes

  1. Well-being

    Time frame: 4 weeks

    Change in General Health Questionnaire (GHQ-12) score

Secondary outcomes

  1. Psychological Flexibility

    Time frame: 4 weeks

    Change in Acceptance and Action Questionnaire (AAQII) score

  2. Values

    Time frame: 4 weeks

    Change in Valuing Questionnaire (VQ) score

  3. Experiential Avoidance

    Time frame: 4 weeks

    Change in Experiential Avoidance in Caregiving Questionnaire (EACQ) score

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • Brain Injury Rehabilitation Trust

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2015
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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