Evaluating a CFT Group for Adults With Acquired Brain Injury

NCT06316258 | Not Yet Recruiting

• 1 other identifier: 333112
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acquired Brain Injury Including Stroke

Outcome Measures

Primary Outcomes (9)

• Demand - patients referred and screened for the group

  Number of patients referred and screened

  At screening/enrollment

• Demand - patients recruited

  Number of patients recruited to group

  At screening/enrollment

• Demand - attendance

  Session attendance rate

  Weeks 1-6 at each weekly group session

• Implementation - patients per group

  Number of patients per group

  Weeks 1-6 at each weekly group session

• Implementation - group sessions completed

  Number of group sessions completed out of 6

  Weeks 1-6 at each weekly group session

• Implementation - practice sessions completed

  Number of additional practice sessions completed out of 6

  Weeks 1-6 at each weekly group session

• 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

• 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

• Acceptability - patient interview feedback

  Feedback from attendees collected via recorded semi-structured interviews after end of intervention

  Interview time point after week 6

Secondary Outcomes (4)

• Change in emotional distress questionnaire score

  2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up

• Change in mental well-being questionnaire score

  2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up

• Change in self-compassion questionnaire score

  2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up

• Change in quality of life questionnaire score

  2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up

Study Arms (1)

Compassion focused therapy group

EXPERIMENTAL

6 week compassion focused therapy group for adults with ABI

Behavioral: Compassion focused therapy group

Interventions

Compassion focused therapy group BEHAVIORAL

6 session compassion focused therapy group for adults with ABI

Compassion focused therapy group

Eligibility Criteria

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

You may qualify if:

• Has experienced a non-progressive acquired brain injury
• Is at least 18 years old
• Has capacity to consent to take part in the group and associated research project
• 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.

You may not qualify if:

• 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.
• 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.
• Is currently experiencing a severe mental health disorder or crisis that would impact on their ability to participate in the group.

Sponsors & Collaborators

• King's College London: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 18, 2024
• Study Start: May 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-02