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Table 2 Overview of intervention rationale, materials and procedures

From: 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

Brief name of interventionPost Stroke Intervention Trial In Fatigue (The POSITIF Trial)
Why (rationale for treatment)Post-stroke fatigue is common, experienced by approximately half of all stroke survivors. It has a negative impact on a range of important life domains. A systematic review of the literature found that psychological factors, namely, depression, anxiety, low self-efficacy, passive coping, reduced physical activity, sleep problems and low levels of social support are implicated in the development or maintenance of fatigue following stroke. This evidence suggests that cognitive behavioural treatment methods, which target individuals’ thoughts, behaviours and feelings, and have been used to treat fatigue in other health conditions, could be effective in the treatment of post-stroke fatigue.
What (materials)POSITIF is a manualised cognitive behaviourally informed treatment that targets the factors that have been associated with post-stroke fatigue in the literature. Individuals will receive a participant manual that includes written information about post-stroke fatigue, as well as activity and sleep diaries and worksheets for goal setting and thought challenging. Before POSITIF, the materials were provided to 12 stroke survivors in a small uncontrolled pilot study and edited to take account of participant and clinician feedback (see Table 1).
What (procedures)Information will be provided to participants about post-stroke fatigue and individuals will be given an opportunity to discuss their ‘model’ of fatigue, i.e. why they believe they experience it. Any misconceptions about fatigue will be corrected. Activity diaries and sleep diaries will be completed by participants throughout the intervention and sent to the therapist (by post); these will form the basis for a tailored approach designed to promote a balance between daily activities, rest and sleep, the aims being to gradually increase levels of physical activity, and to avoid ‘boom and bust’ activity patterns. Therapists will identify participant beliefs about fatigue and help participants to challenge negative thinking, encouraging them overcome any fears about undertaking physical activity (see Table 1). The comparator group will receive written information about fatigue only, in the form of a leaflet (available at www.strokeassociation/dudfuhfud.com).
Who (profession, expertise, specific training, etc)The intervention is to be delivered by nurses or Allied Health Professionals (AHPs). These therapists will be individuals with clinical experience of stroke, but no prior training in Cognitive Behavioural Therapy (CBT). They will be representative of the nurses who work with stroke survivors in community stroke settings. Therapists will receive a one-day training that comprises an overview of the literature on post-stroke fatigue, an introduction to the principles and practice of CBT, and information on how to deliver the intervention, including how to record the content of sessions. A stroke clinical psychologist and a cognitive behavioural psychotherapist will deliver the training. Brief role plays and group discussions will be included; reading materials, including journal articles will be provided to trial therapists for self-study. Nurse/AHP therapists will receive fortnightly telephone supervision (30-minutes duration) from the stroke clinical psychologist who delivers the training.
How (modes of delivery)POSITIF sessions will be telephone-delivered. Phone calls will be made at times convenient to participants. Therapists will try to call participants at least two or three times before a session is classed as ‘missed’, as would happen in clinical practice. Participants will be required to have their written manuals in front of them during the calls so that therapists can direct them to particular worksheets and other materials.
Where (infrastructure and relevant features)Participants will receive the telephone sessions in their own homes. They will receive the participant manuals by post.
When and how much (number of sessions, duration, intensity, dose)The intervention comprises six sessions, one every two weeks. Sessions will be up to 60 minutes in duration. In the intervals between sessions, participants will work on their chosen goals. A review ‘booster’ telephone session will take place two to four weeks after the sixth session.
Tailoring (personalisation)Goals will be individualised for each patient to take account of their baseline level of activity and sleep patterns, their physical health, levels of fatigue and their interests and aspirations.
Modifications (from existing or initial protocol)Any modifications that are required in the course of the intervention will be recorded.
How well (planned adherence)Adherence to the intervention will be determined as number of sessions each participant receives.