Evaluating a CFT Group for Adults With Acquired Brain Injury

Acquired Brain Injury Including Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06316258
• Other study ID #: 333112
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: February 2024
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury Including Stroke
• Brain Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Compassion focused therapy group
6 session compassion focused therapy group for adults with ABI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demand - patients referred and screened for the group	Number of patients referred and screened	At screening/enrollment
Primary	Demand - patients recruited	Number of patients recruited to group	At screening/enrollment
Primary	Demand - attendance	Session attendance rate	Weeks 1-6 at each weekly group session
Primary	Implementation - patients per group	Number of patients per group	Weeks 1-6 at each weekly group session
Primary	Implementation - group sessions completed	Number of group sessions completed out of 6	Weeks 1-6 at each weekly group session
Primary	Implementation - practice sessions completed	Number of additional practice sessions completed out of 6	Weeks 1-6 at each weekly group session
Primary	Practicality - delivery of intervention	The number of items covered in the session out of the items that were planned in the session guide	Weeks 1-6 at each weekly group session
Primary	Acceptability - end of session ratings scores	Patient ratings of enjoyment, understanding and helpfulness using 'Session Rating Form' designed for study	Weeks 1-6 at each weekly group session
Primary	Acceptability - patient interview feedback	Feedback from attendees collected via recorded semi-structured interviews after end of intervention	Interview time point after week 6
Secondary	Change in emotional distress questionnaire score	Measured using Hospital Anxiety Depression Scale (HADS)	2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Secondary	Change in mental well-being questionnaire score	Measured using Warwick Edinburgh Mental Well-Being Scale (WEMWBS)	2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Secondary	Change in self-compassion questionnaire score	Measured using Self-Compassion Scale Short Form (SCS-SF)	2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Secondary	Change in quality of life questionnaire score	Measured using Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)	2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up