STRICTLy CFT: a Compassion Focussed Therapy Intervention to Aid Recovery Post-stroke

NCT03923946 | Completed

• 1 other identifier: 181002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

Individuals who have had a stroke are at greater risk of developing distress (e.g. depression and anxiety). These individuals are also likely to be highly critical of themselves as they are no longer able to do the things they used to be able to do. Compassion Focused Therapy is a form of psychotherapy aimed at reducing an individual's self-criticism and increasing their self-compassion. CFT has been found to be effective at reducing distress in the general population and there is emerging evidence in the brain injury population. However, to date, there has not been a rigorous study to establish the effectiveness of CFT. Therefore, this feasibility randomised control trial aims to: Establish the feasibility of recruitment, randomisation, and retention of participants; determine the acceptability and feasibility of a CFT intervention within a stroke population; determine the suitability of pre and post measures for assessing the impact of the intervention; Analyse the cost-effectiveness of the study; Establish effect sizes to enable an accurate estimation of the number of participants needed in a full scale RCT to find a treatment effect. Individuals will be randomised into either a CFT intervention group, an active control arm (akin to a befriending type service) or a treatment as usual arm. Participants will receive up to three one hour sessions of CFT (intervention group) or befriending (active control group) or will not receive any additional support (treatment as usual group). A total of 36 participants will be recruited, 12 in each arm of the study. Participants will be recruited from the Early Supported Stroke Discharge Teams within Derbyshire. Participants will complete well-being, distress and self-criticism measures, pre, post and at 4 months follow-up. A semi-structured interview will also be conducted with a selection of participants from each arm.

Conditions

Stroke

Keywords

Stroke; Compassion Focused Therapy; CFT; Distress; Feasibility RCT

Outcome Measures

Primary Outcomes (1)

• Feasibility of an RCT design

  Answers from post-intervention interviews

  4 months (per participant)

Secondary Outcomes (3)

• distress

  6 weeks

• well-being

  6 weeks

• Process

  6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Compassionate Imagery Intervention- up to three 1:1 sessions, up to one hour each with the primary researcher

Behavioral: Compassion focused therapy

Control

NO INTERVENTION

Treatment as usual arm

Interventions

Compassion focused therapy BEHAVIORAL

Compassionate Imagery intervention based on compassionate imagery exercises in The Compassionate Mind Workbook by Irons and Beaumont, 2017

Intervention

Eligibility Criteria

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

You may qualify if:

• Eligible for the early supported discharge pathway this includes:
• Confirmed diagnosis of a new stroke.
• Over 18 Years old.
• Able to consent to being in the study.
• The patient and their family/carer agree to rehabilitation process continuing at home.
• The home environment is conducive to the community-based rehabilitation.
• Achievable rehabilitation goals can be identified.
• Document acknowledgement that the patient is sufficiently well enough from a medical perspective to be managed in the community.
• The patient's language and/or cognitive skills are at a level for them to manage on their own for periods as is necessary.
• In addition to ESSD criteria participants must;
• Have a good grasp of the English language
• Have been discharged from the ESSD pathway

You may not qualify if:

• Participants will be excluded if they:
• Have any communication difficulties that would prevent them from engaging in the intervention (including hearing impairments, visual impairments, inability to understand English). These will be assessed at researcher's discretion during baseline assessments.
• Had a diagnosis of dementia prior to the stroke.
• Are deemed to lack capacity to give informed consent. This will be judged via a qualified clinician.
• Have had previous experience of CFT
• Were receiving medical or psychological treatment for a mental illness at the time of their stroke.

Sponsors & Collaborators

• University of Lincoln: lead

Study Sites (2)

Derbyshire Community Hospitals

Derby, United Kingdom

Location

Royal Derby Hospital

Derby, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the active nature of the interventions it is not possible to mask participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility RCT

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 23, 2019
• Study Start: May 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)