TY - JOUR
T1 - 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
AU - Gillespie, David C.
AU - Barber, Mark
AU - Brady, Marian C.
AU - Carson, Alan
AU - Chalder, Trudie
AU - Chun, Yvonne
AU - Cvoro, Vera
AU - Dennis, Martin
AU - Hackett, Maree
AU - Haig, Euan
AU - House, Allan
AU - Lewis, Steff
AU - Parker, Richard
AU - Wee, Fiona
AU - Wu, Simiao
AU - Mead, Gillian
N1 - Acceptance in SAN
OA journal
Accepted date changed from '22 May 2020' to '25 May 2020' - Acceptance from webpage (CR - 22/06/20)
PY - 2020/6/15
Y1 - 2020/6/15
N2 - 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.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.Trial registration: ClinicalTrials.gov, NCT03551327. Registered on 11 June 2018.
AB - 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.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.Trial registration: ClinicalTrials.gov, NCT03551327. Registered on 11 June 2018.
KW - stroke
KW - fatigue
KW - physical activity
KW - rehabilitation
KW - psychological
KW - cognitive behavioural approach
KW - telephone
KW - clinical trial
U2 - 10.1186/s40814-020-00622-0
DO - 10.1186/s40814-020-00622-0
M3 - Article
C2 - 32549995
VL - 6
SP - 1
EP - 14
JO - Pilot and Feasibility Studies
JF - Pilot and Feasibility Studies
SN - 2055-5784
M1 - 84
ER -