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Evaluating a CFT Group for Adults With Acquired Brain Injury

Evaluating the Feasibility and Acceptability of Compassion Focused Therapy Group Intervention for Adults With Moderate-severe Acquired Brain Injury in an Inpatient Neurorehabilitation Setting

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06316258
Enrollment
12
Registered
2024-03-18
Start date
2024-05-01
Completion date
2025-05-30
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury Including Stroke

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.

Interventions

BEHAVIORALCompassion focused therapy group

6 session compassion focused therapy group for adults with ABI

Sponsors

King's College London
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability - patient interview feedbackInterview time point after week 6Feedback from attendees collected via recorded semi-structured interviews after end of intervention
Implementation - group sessions completedWeeks 1-6 at each weekly group sessionNumber of group sessions completed out of 6
Implementation - practice sessions completedWeeks 1-6 at each weekly group sessionNumber of additional practice sessions completed out of 6
Practicality - delivery of interventionWeeks 1-6 at each weekly group sessionThe number of items covered in the session out of the items that were planned in the session guide
Acceptability - end of session ratings scoresWeeks 1-6 at each weekly group sessionPatient ratings of enjoyment, understanding and helpfulness using 'Session Rating Form' designed for study
Demand - patients referred and screened for the groupAt screening/enrollmentNumber of patients referred and screened
Demand - patients recruitedAt screening/enrollmentNumber of patients recruited to group
Demand - attendanceWeeks 1-6 at each weekly group sessionSession attendance rate
Implementation - patients per groupWeeks 1-6 at each weekly group sessionNumber of patients per group

Secondary

MeasureTime frameDescription
Change in mental well-being questionnaire score2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-upMeasured using Warwick Edinburgh Mental Well-Being Scale (WEMWBS)
Change in self-compassion questionnaire score2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-upMeasured using Self-Compassion Scale Short Form (SCS-SF)
Change in quality of life questionnaire score2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-upMeasured using Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
Change in emotional distress questionnaire score2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-upMeasured using Hospital Anxiety Depression Scale (HADS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026