Recovery Enhancement From Traumatic Brain Injury Using Acceptance and Commitment Therapy - a Pilot Study.

NCT02337114 | Completed Early Phase 1

• 1 other identifier: 14/WS/1152
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Keywords

Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (3)

• Acceptability of ACT as measured by focus-group discussions with clients and staff; number of participants withdrawing from study

  Qualitative thematic analysis of focus-group discussions with clients and staff; number of participants withdrawing from study

  9 weeks

• Suitability of ACT as measured by Acceptance and Action Questionnaire - Acquired Brain Injury

  Quantitative comparison between groups of results of Acceptance and Action Questionnaire - Acquired Brain Injury

  9 weeks

• Feasibility of ACT as measured by focus-group discussions with clients and staff; number of participants considering intervention satisfactory/appropriate

  Qualitative thematic analysis of focus-group discussions with clients and staff; number of participants considering intervention satisfactory/appropriate

  9 weeks

Secondary Outcomes (3)

• Suitability of ACT, as measured by Hospital Anxiety and Depression Scale

  9 weeks

• Suitability of ACT as measured by the Motivation for Traumatic Brain Injury Rehabilitation Questionnaire

  9 weeks

• Suitability of ACT as measured by Awareness Questionnaire

  9 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Treatment as Usual and Acceptance \& Commitment Therapy

Behavioral: Acceptance and Commitment Therapy; Behavioral: Treatment as Usual

Comparison group

OTHER

Treatment as Usual

Behavioral: Treatment as Usual

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

A psychotherapeutic intervention that aims to enhance individuals' willingness to have difficult experiences but persist with behaviours that reflect what is important to them.

Intervention group

Treatment as Usual BEHAVIORAL

A client-centred goal planning system linked to community reintegration and based on a holistic rehabilitation model including counselling, medical management, cognitive behavioural therapy and pharmacotherapy.

Comparison group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead
• Brain Injury Rehabilitation Trust: collaborator

Study Sites (1)

Brain Injury Rehabilitation Trust

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Acceptance and Commitment Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hamish McLeod, PhD CPsychol

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Programme Director for Doctorate in Clinical Psychology and Senior Lecturer

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: January 13, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

GB (1)