REACT - Recovery Enhancement From TBI Using ACT. A Pilot Study.
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- University of Glasgow
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Suitability of ACT as measured by Acceptance and Action Questionnaire - Acquired Brain Injury
Study Overview
Brief Summary
Is Acceptance and Commitment Therapy (ACT) feasible and acceptable for adults with severe Traumatic Brain Injury (sTBI) in inpatient services? sTBI is associated with depression, anxiety and low self awareness. A key factor in recovery is adjustment to the effects of injury. Psychological intervention may facilitate this change; however what works is unclear. ACT seeks to improve psychological flexibility; the ability to be present with difficult thoughts and emotions, rather than fighting them, and to accept ourselves as we are, not what we believe we should be. Current research is limited, but what is published suggests it may be useful for this group.
Due to the limited research this pilot study aims to conduct preliminary analysis on the acceptability and feasibility of ACT for people with sTBI whilst also examining the suitability of the study protocol in order to make recommendations for future studies. Clients and staff from three Brain Injury Rehabilitation Trust (BIRT) centres will be recruited, one of which will serve as the intervention centre.
Clients in the intervention group will be asked to complete questionnaires a week before and after participation in the 6 week ACT programme. Clients in the comparison group will be asked to complete questionnaires a week before and after receiving 6 weeks of treatment as usual (TAU). The treatment group will also receive TAU. All participants will be invited to participate in a focus group at the end of this 8 week period to discuss their involvement in the study.
Staff will be asked to complete a parallel version of one of the client questionnaires within a similar timeframe. In addition staff at the intervention centre will be invited to attend a focus group and complete an additional questionnaire after the eight week period.
Detailed Description
A pilot study design will initially assess the feasibility and acceptability of the ACT and study protocol with this client group in order to inform a future clinical trial.
The methodology involves both quantitative and qualitative methods and will involve inpatients at Brain Injury Rehabilitation Trust (BIRT) units, staff involved in the day to day care of inpatients and clinicians involved in the administration of therapy. Quantitative methods (questionnaires) were chosen to assess any possible change in assessment measures. The measures chosen have been previously used. They have good validity (the ability to answer the questions asked) and reliability, and therefore are practically suitable for measuring outcomes of therapy. Qualitative methods (focus groups) were also chosen, owing to the pilot nature of this research, in order to obtain personal opinion on the acceptability of the intervention and the treatment protocol, from those participating.
The intervention will be administered, alongside TAU, to inpatients at a BIRT centre in Glasgow and will be compared to a comparison group which will receive TAU only (who will be based in BIRT centres in either York and/or Leeds). The rational for choosing a BIRT centre in Glasgow for the intervention group is one of convenience as all researchers involved in the study are based in Glasgow. This will help facilitate data collection and reduce cost. Given that all BIRT centres adhere to a similar philosophy of care and rehabilitation and service user profiles are relatively similar, it was believed that recruiting elsewhere for the purpose of comparison would be appropriate. Recruiting treatment and comparison groups from separate centres also ensures that clients receiving TAU only do not learn ACT strategies accidentally through discussion with peers or staff. If this were to happen any indication of change could not be attributed to the difference in treatments provided.
Five participant groups will be recruited:
- clients in the inpatient setting (treatment group),
- clients in the inpatient setting (comparison group),
- care staff working directly with clients (treatment group),
- care staff working directly with clients (comparison group)
- psychology staff involved in administering the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All clients must:
- •have sustained a severe TBI after the age of 18; indicated by presence of posttraumatic amnesia for a day or more OR loss of consciousness for 30 minutes or more following injury OR scores of eight or less on the Glasgow Coma Scale.
- •have sufficient English language skills to enable valid participation using standard tests and questionnaires
- •be admitted to BIRT for neuropsychological rehabilitation
- •have sufficient cognitive capacity to complete questionnaires independently and participate in discussions as part of the ACT intervention.
- •All psychology staff must have:
- •completed 1.5 day ACT training
- •time and resources to:
- •administer ACT intervention to at least one group of 3-4 clients once a week for a six week period within the time frame suggested for this pilot study
- •participate in a focus group following intervention providing their views of the study protocol
- •complete the SAFE questionnaire identifying barriers to treatment implementation
- •Care staff not involved in delivering the intervention (including nursing staff and rehabilitation support workers)
- •will have the time and resources to complete 2 questionnaires
- •work directly with the clients receiving the intervention
- •have commenced at BIRT employment prior to the first intervention session.
- •will have the time and resources to participate in the focus group, if based at Graham Anderson House
Exclusion Criteria
- •Clients will be excluded from the study if they:
- •lack capacity to consent to participate in research as assessed by staff at BIRT or by the researcher when discussing consent with the participant
- •will remain in the unit for less than eight weeks
- •have challenging behaviour that may put the researcher or participant at risk or prevent participation in the study.
- •Psychology staff will be excluded if:
- •they have not received the appropriate training
- •they consider that do not have the time and resources to partake in all the research tasks.
- •Care staff will be excluded from this study if:
- •they have commenced employment after the study procedures have commenced
- •they believe they do not have the time and resources to complete research tasks
- •they do not work directly with clients participating in study
Outcomes
Primary Outcomes
Suitability of ACT as measured by Acceptance and Action Questionnaire - Acquired Brain Injury
Time Frame: 9 weeks
Quantitative comparison between groups of results of Acceptance and Action Questionnaire - Acquired Brain Injury
Feasibility of ACT as measured by focus-group discussions with clients and staff; number of participants considering intervention satisfactory/appropriate
Time Frame: 9 weeks
Qualitative thematic analysis of focus-group discussions with clients and staff; number of participants considering intervention satisfactory/appropriate
Acceptability of ACT as measured by focus-group discussions with clients and staff; number of participants withdrawing from study
Time Frame: 9 weeks
Qualitative thematic analysis of focus-group discussions with clients and staff; number of participants withdrawing from study
Secondary Outcomes
- Suitability of ACT, as measured by Hospital Anxiety and Depression Scale(9 weeks)
- Suitability of ACT as measured by Awareness Questionnaire(9 weeks)
- Suitability of ACT as measured by the Motivation for Traumatic Brain Injury Rehabilitation Questionnaire(9 weeks)
Investigators
Hamish J McLeod PhD CPsychol
Programme Director for Doctorate in Clinical Psychology and Senior Lecturer
University of Glasgow