STRICTLy CFT: a Compassion Focussed Therapy Intervention to Aid Recovery Post-stroke
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|ClinicalTrials.gov Identifier: NCT03923946|
Recruitment Status : Completed
First Posted : April 23, 2019
Last Update Posted : November 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Compassion focused therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Feasibility RCT|
|Masking:||None (Open Label)|
|Masking Description:||Due to the active nature of the interventions it is not possible to mask participants.|
|Official Title:||STRICTLy CFT: A Feasibility Randomised Control Trial of a Compassion Focussed Therapy Intervention to Aid Recovery Post-stroke|
|Actual Study Start Date :||May 1, 2019|
|Actual Primary Completion Date :||June 30, 2020|
|Actual Study Completion Date :||June 30, 2020|
Compassionate Imagery Intervention- up to three 1:1 sessions, up to one hour each with the primary researcher
Behavioral: Compassion focused therapy
Compassionate Imagery intervention based on compassionate imagery exercises in The Compassionate Mind Workbook by Irons and Beaumont, 2017
No Intervention: Control
Treatment as usual arm
- Feasibility of an RCT design [ Time Frame: 4 months (per participant) ]Answers from post-intervention interviews
- distress [ Time Frame: 6 weeks ]Analysing pre-post scores on the Hospital Anxiety and Depression Scale (HADS). The HADS has two sub-scales; an anxiety sub-scale and a depression sub-scale (both range from 0-21, with higher scores indicating more distress).
- well-being [ Time Frame: 6 weeks ]Analysing pre-post scores on the Warwick Edinburgh Mental Well-being Scale (WEMWBS). A total score is calculated by summing answers on all questions and ranges form 14-70 with higher scores indicating greater well-being.
- Process [ Time Frame: 6 weeks ]Analysing pre-post scores on the Self-Compassion Scale (SCS). This scale has 4 sub-scales. Subscale scores are computed by calculating the mean of subscale item responses. To compute a total self-compassion score, reverse score the negative subscale items before calculating subscale means - self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3. 4 = 2, 5 = 1) - then compute a grand mean of all six subscale means. Researchers can choose to analyze their data either by using individual sub-scale sores or by using a total score. Subscale scores range form 5-25 with higher scores indicating more compassion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923946
|Derbyshire Community Hospitals|
|Derby, United Kingdom|
|Royal Derby Hospital|
|Derby, United Kingdom|