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Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue

Research output: Contribution to journalArticle

David Gillespie, Mark Barber, Marian C. Brady, Alan Carson, Trudie Chalder, Yvonne Chun, Vera Cvoro, Martin Dennis, Maree Hackett, Euan Haig, Allan House, Steff Lewis, Richard Parker, Fiona Wee, Simiao Wu, Gillian Mead

Original languageEnglish
JournalPilot and Feasibility Studies
Publication statusAccepted/In press - 22 May 2020


King's Authors


Background: Approximately half of stroke survivors experience fatigue. Fatigue may persist for many months and interferes with participation in everyday activities, and has a negative impact on social and family relationships, return to work, and quality of life. Fatigue is among the top 10 priorities for ‘Life after Stroke’ research for stroke survivors, carers and clinicians. We previously developed and tested in a small uncontrolled pilot study a manualised, clinical psychologist-delivered, face-to-face intervention, informed by cognitive behavioural therapy (CBT). We then adapted it for delivery by trained therapists via telephone. We now aim to test the feasibility of this approach in a parallel group, randomised controlled feasibility trial (Post Stroke Intervention Trial In Fatigue, POSITIF).
Methods/design: POSITIF aims to recruit 75 stroke survivors between 3 months and 2 years post-stroke who would like treatment for their fatigue. Eligible consenting stroke survivors will be randomised to either a 7-session manualised telephone delivered intervention based on CBT principles plus information about fatigue, or information only. The aims of the intervention are to: (i) provide an explanation for post-stroke fatigue, in particular that it is potentially reversible (an educational approach), (ii) encourage participants to overcome the fear of taking physical activity, and challenge negative thinking (a cognitive approach) and (iii) promote a balance between daily activities, rest and sleep and then gradually increase levels of physical activity (a behavioural approach). Fatigue, mood, quality of life, return to work and putative mediators will be assessed at baseline (just before randomisation), at the end of treatment and six months after randomisation. POSITIF will determine the feasibility of recruitment, adherence to the intervention, and the resources required to deliver the intervention in a larger trial.
Discussion: The POSITIF feasibility trial will recruit until 31 January 2020. Data will inform the utility and design of a future adequately powered randomised controlled trial.

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