Post stroke intervention trial in fatigue (POSITIF): Randomised multicentre feasibility trial.
Gillian Mead, David Gillespie, Mark Barber and 5 others
PMID 35866206WHAT IT FOUND
Telephone-delivered CBT for post-stroke fatigue showed no significant benefit over a leaflet at six months.
Both groups improved similarly. The intervention was feasible to deliver but adherence was low, with only 59% of the intervention group attending four or more sessions.
Key findings
01There was no statistically significant difference between the intervention and control groups for fatigue, anxiety, or depression scores at six months.
02Fatigue scores fell by around 4 points in both the intervention and control groups between baseline and six-month follow-up.
03Adherence to the intervention was low, with only 59% of those randomised to the intervention attending at least four sessions.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTsWhat it means for SLPs
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What it does not show
This was a feasibility trial, not powered to detect clinical differences, so the null results should not be interpreted as proof that the intervention is ineffective. Only 59% of the intervention group completed four or more sessions, meaning the 'dose' of therapy received was low for many participants. The control group received a Stroke Association leaflet, which may have had a therapeutic effect, as fatigue scores improved in both groups. The intervention was delivered by staff with only brief CBT training, which may have limited the potency of the therapy compared to delivery by trained CBT therapists. Participants were generally younger and less disabled than the typical stroke population, limiting generalisability.
Declared interests
The authors declared no conflicts of interest. The study was funded by Chest Heart & Stroke Scotland, though the funder had no influence on trial design or analysis.
The easy way to misread this
Do not conclude that telephone CBT is ineffective for post-stroke fatigue based on this trial. It was a feasibility study with low statistical power and poor adherence, so the null finding reflects the study's limitations rather than definitively proving the intervention does not work.