Acquired Brain Injury Including StrokeNCT06316258
Evaluating a CFT Group for Adults With Acquired Brain Injury
A study testing Compassion focused therapy group in people with Acquired Brain Injury Including Stroke, run by King's College London.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury Including Stroke
- What is being tested?
- Compassion focused therapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- Compassion focused therapy group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion focused therapy groupBehavioural
6 session compassion focused therapy group for adults with ABI
| Study group | Role | What they receive |
|---|---|---|
| Compassion focused therapy group | Experimental | 6 week compassion focused therapy group for adults with ABI Receives: Behavioral: Compassion focused therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand - patients referred and screened for the group
Number of patients referred and screened
Measured: At screening/enrollment
Demand - patients recruited
Number of patients recruited to group
Measured: At screening/enrollment
Demand - attendance
Session attendance rate
Measured: Weeks 1-6 at each weekly group session
Implementation - patients per group
Number of patients per group
Measured: Weeks 1-6 at each weekly group session
Implementation - group sessions completed
Number of group sessions completed out of 6
Measured: Weeks 1-6 at each weekly group session
Implementation - practice sessions completed
Number of additional practice sessions completed out of 6
Measured: 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
Measured: 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
Measured: 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
Measured: Interview time point after week 6
Secondary outcomes (4)
Change in emotional distress questionnaire score
Measured using Hospital Anxiety Depression Scale (HADS)
Measured: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Change in mental well-being questionnaire score
Measured using Warwick Edinburgh Mental Well-Being Scale (WEMWBS)
Measured: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Change in self-compassion questionnaire score
Measured using Self-Compassion Scale Short Form (SCS-SF)
Measured: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Change in quality of life questionnaire score
Measured using Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
Measured: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury Including StrokeStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316258
- Sponsor's protocol ID
- 333112
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06316258
- Acronym / sponsor ID
- 333112
- Conditions
- Acquired Brain Injury Including Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compassion focused therapy group | Experimental | Behavioral: Compassion focused therapy group6 week compassion focused therapy group for adults with ABI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion focused therapy group6 session compassion focused therapy group for adults with ABI | Behavioural | Compassion focused therapy group |
Primary outcome
Demand - patients referred and screened for the group
Time frame: At screening/enrollment
Number of patients referred and screened
Demand - patients recruited
Time frame: At screening/enrollment
Number of patients recruited to group
Demand - attendance
Time frame: Weeks 1-6 at each weekly group session
Session attendance rate
Implementation - patients per group
Time frame: Weeks 1-6 at each weekly group session
Number of patients per group
Implementation - group sessions completed
Time frame: Weeks 1-6 at each weekly group session
Number of group sessions completed out of 6
Implementation - practice sessions completed
Time frame: Weeks 1-6 at each weekly group session
Number of additional practice sessions completed out of 6
Practicality - delivery of intervention
Time frame: Weeks 1-6 at each weekly group session
The number of items covered in the session out of the items that were planned in the session guide
Acceptability - end of session ratings scores
Time frame: Weeks 1-6 at each weekly group session
Patient ratings of enjoyment, understanding and helpfulness using 'Session Rating Form' designed for study
Acceptability - patient interview feedback
Time frame: Interview time point after week 6
Feedback from attendees collected via recorded semi-structured interviews after end of intervention
4 secondary outcomes
Change in emotional distress questionnaire score
Time frame: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Change in mental well-being questionnaire score
Time frame: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Change in self-compassion questionnaire score
Time frame: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Change in quality of life questionnaire score
Time frame: 2-week Baseline, week 1 (pre-group), week 6 (post-group), 2-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion focused therapy group in people with Acquired Brain Injury Including Stroke, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demand - patients referred and screened for the group (time frame: At screening/enrollment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.