Clinical trial NCT06316258: Evaluating a CFT Group for Adults With Acquired Brain Injury
Official title: Evaluating the Feasibility and Acceptability of Compassion Focused Therapy Group Intervention for Adults With Moderate-severe Acquired Brain Injury in an Inpatient Neurorehabilitation Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acquired Brain Injury Including Stroke
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Emotional difficulties such as anxiety and depression are common after experiencing a brain injury. The compassion focused therapy (or CFT) model proposes the importance of developing skills in being able to self-soothe and be self-compassionate to counteract feelings of distress. Several studies have shown that therapy groups using CFT techniques are helpful, but there has only been one previous study of a CFT group with people with acquired brain injury. This study aims to evaluate a new CFT group for people who have had a brain injury and are currently receiving inpatient neuro-rehabilitation. The group will have six weekly sessions with 4-6 people in each group. The group will be run at the inpatient neuro-rehabilitation unit. As this is a new group that has not been run before, it will be a small study to see whether the group is feasible and acceptable to attendees. The study will evaluate whether the group can be run as planned and how many people attend. The investigators will also interview people who attended the group to find out what they thought of the group.

The study also aims to use four questionnaires measuring emotional distress, well-being, self-compassion and quality of life to measure the effect of the group. Group attendees questionnaire scores from before and after the group will be compared to see if there has been any change due to attending the group.

This project is being completed as part of a Doctorate in Clinical Psychology at King's College London, and will be recruiting patients from an inpatient neurorehabilitation setting.


Eligibility criteria: Inclusion Criteria:

1. Has experienced a non-progressive acquired brain injury
2. Is at least 18 years old
3. Has capacity to consent to take part in the group and associated research project
4. Is currently experiencing emotional distress, as identified descriptively by the treating team and indicated by a minimum score of 8 or above (mild symptoms) on the HADS.

Exclusion Criteria:

1. Has a \[severe\] cognitive impairment to a degree that this is considered by the treating team to prevent their ability to participate in the group despite adaptations.
2. Has a \[severe\] communication impairment to a degree that is considered by the treating team to prevent their ability to participate in or understand the group content despite adaptations.
3. Is currently experiencing a severe mental health disorder or crisis that would impact on their ability to participate in the group.

Primary outcomes:
measure: Demand - patients referred and screened for the group
timeFrame: At screening/enrollment
measure: Demand - patients recruited
timeFrame: At screening/enrollment
measure: Demand - attendance
timeFrame: Weeks 1-6 at each weekly group session
measure: Implementation - patients per group
timeFrame: Weeks 1-6 at each weekly group session
measure: Implementation - group sessions completed
timeFrame: Weeks 1-6 at each weekly group session
measure: Implementation - practice sessions completed
timeFrame: Weeks 1-6 at each weekly group session
measure: Practicality - delivery of intervention
timeFrame: Weeks 1-6 at each weekly group session
measure: Acceptability - end of session ratings scores
timeFrame: Weeks 1-6 at each weekly group session
measure: Acceptability - patient interview feedback
timeFrame: Interview time point after week 6
Secondary outcomes:
measure: Change in emotional distress questionnaire score
timeFrame: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
measure: Change in mental well-being questionnaire score
timeFrame: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
measure: Change in self-compassion questionnaire score
timeFrame: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
measure: Change in quality of life questionnaire score
timeFrame: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Other outcomes:
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