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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
Sponsor:
Information provided by (Responsible Party):
University of Lincoln

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.


Condition or disease Intervention/treatment Phase
Stroke Behavioral: Compassion focused therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Intervention
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



Primary Outcome Measures :
  1. Feasibility of an RCT design [ Time Frame: 4 months (per participant) ]
    Answers from post-intervention interviews


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Derbyshire Community Hospitals
Derby, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Sponsors and Collaborators
University of Lincoln
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Responsible Party: University of Lincoln
ClinicalTrials.gov Identifier: NCT03923946    
Other Study ID Numbers: 181002
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Lincoln:
Stroke
Compassion Focused Therapy
CFT
Distress
Feasibility RCT
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases