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

Abstract

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 6 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.

Fatigue 7 years post‐stroke: Predictors and correlated features

“…9 Large interventional data are lacking to date, but recently the study protocol for an interventional study investigating cognitivebehavioral intervention including physical activity was published. 43 From our results, we cannot draw any conclusions about causality, but provide further observational support that physical activity merits evaluation as an intervention to treat PSF. Finally, we observed a correlation between insomnia and PSF that was significantly stronger in women as compared to men.…”

“…Furthermore, a small randomized pilot trial demonstrated that the combination of cognitive–behavioral therapy and graded activity training was more effective than cognitive–behavioral therapy alone in treating PSF 9 . Large interventional data are lacking to date, but recently the study protocol for an interventional study investigating cognitive–behavioral intervention including physical activity was published 43 . From our results, we cannot draw any conclusions about causality, but provide further observational support that physical activity merits evaluation as an intervention to treat PSF.…”

Reducing severe fatigue in patients with diffuse glioma: a study protocol for an RCT on the effect of blended cognitive behavioural therapy

“…CBT as a treatment for fatigue also seems promising in patients with neurological disease. It has shown to be effective in reducing severe fatigue in patients with multiple sclerosis [ 28 ] and is studied in treating post-stroke fatigue [ 29 , 30 ]. Whether fatigued patients with diffuse glioma could benefit from CBT to resolve or reduce fatigue remains to be determined.…”