Positive psychotherapy for people with a brain injury

Not Applicable

• Conditions: Acquired brain injury; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN12690685
• Lead Sponsor: Research & Development, Swansea Bay University Local Health Board

Brief Summary

2024 Protocol article in https://doi.org/10.1186/s40814-024-01459-7 (added 22/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-11
• Last Update Posted: 4 March 2024
• Study Completion: 2024-03-18

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Confirmed diagnosis of ABI
2. Ability to actively engage in the intervention as determined by their neuropsychological assessment scores and their clinician
3. Living in the community
4. Psychological distress (evidenced by their scores on the Depression, Anxiety and Stress Scales)
5. Age 18 y or older
6. Living within the catchment area of one of the participating health boards
7. At least three-month post injury at the point of recruitment allowing time for spontaneous recovery and for the person to become aware of their difficulties and the implications of this on their lives

Exclusion Criteria

1. Receptive or expressive language difficulties, or extremely low memory function that may preclude people from engaging meaningfully
2. Medical or psycho-social reasons (based on risk assessment by the referring clinician)
3. Potentially disruptive to other group members as determined by their clinician
4. Not able to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome regarding feasibility will be assessed against the ACCEPT criteria for the trial. This includes recruitment across sites, recruitment rate, intervention compliance clinicians, interventions compliance participants, randomisation process, data collection from participants, attrition rates and differences between groups in serious adverse events (SAEs) measured using case report forms and patient records.

Secondary Outcome Measures

Name	Time	Method
1. Psychological distress measured using the DASS-21 at time 1 (before the intervention), 2 (after the intervention), and 3 (follow-up at 3 months) <br>2. Well-being measured using the PERMA profiler at time 1, 2 and 3<br>3. General health and well-being using heart rate variability at time 1, 2 and 3<br>4. General capability measured using the ICECAP-A at time 1, 2 and 3<br>5. General health state and quality of life using the EQ-5D-5L at time 1, 2 and 3<br>6. Health care costs using the client service receipt inventory (CSRI) at time 1 and 3 <br>7. Participant experience of recruitment, eligibility, consent and their experience of several aspects of the intervention (session context, length, homework, their experience of using the materials) will be explored using qualitative methods and analysis. This only applies to the participants who attended the positive psychotherapy group at time 2