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NCT03923946
STRICTLy CFT: a Compassion Focussed Therapy Intervention to Aid Recovery Post-stroke
NA trial testing Compassion focused therapy in Stroke in 24 participants. Completed in 30 June 2020.
30 June 2020
Quick facts
| Lead sponsor | University of Lincoln |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 May 2019 |
| Primary completion | 30 June 2020 |
| Estimated completion | 30 June 2020 |
| Sites | 2 locations across United Kingdom |
Drugs / interventions tested
- Compassion focused therapy
Conditions studied
- Stroke — all drugs for Stroke →
Sponsor
University of Lincoln
Who can join
18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03923946
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Lincoln trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03923946 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Lincoln
- Last refreshed: 5 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03923946.
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