Adapted Solution Focused Brief Therapy in Post-stroke Aphasia (SOFIA Trial): a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- City, University of London
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Warwick Edinburgh Mental Well-being Scale (WEMWBS)
Study Overview
Brief Summary
Around one third of stroke survivors will have aphasia, which means they will have difficulty talking, understanding, reading or writing. The main aims of this study are to assess: [1] the acceptability of an existing psychosocial intervention, solution focused brief therapy, to people with varying presentations of aphasia; and [2] the feasibility of conducting a future definitive trial investigating clinical and cost effectiveness.
Detailed Description
Background and Aims Around one third of people who have a stroke will experience aphasia, a language disability that can affect talking, understanding, reading or writing. The psychosocial impact of aphasia is considerable: those living with chronic aphasia are at risk of social isolation and depression. One potential intervention is Solution Focused Brief Therapy (SFBT). SFBT is an approach to building positive change in a person's life. It builds up a picture of a client's preferred future; encourages a person to notice positive signs of change; explores personal resources, skills and resilience; and acknowledges the impact of the stroke on a person's life and identity.
The current project builds on a small-scale proof-of-concept study that explored SFBT with five people who had mild to moderate aphasia, at least two years post stroke. There were improvements in participants' mood and participation and participants found the therapy highly acceptable.
The main aims of the current project are to assess: [1] the acceptability of SFBT to people with varying presentations of aphasia; and [2] the feasibility of conducting a future definitive trial investigating clinical and cost effectiveness.
Methods The overall study will last for 38 months (November 2016 to December 2019), and comprise a Development Phase (year 1) and a single-blind, randomized, wait-list controlled, feasibility trial with nested qualitative research comparing SFBT plus usual care to usual care alone (years 2 and 3).
During the Development Phase the investigators will develop the therapy manual and fidelity checking processes, train the clinicians, and finalize the protocol. Phase One has been informed through four workshops with the Aphasia Advisory Group, comprised of four people with aphasia and one carer, who advised on the study protocol and trial documentation. The investigators also conducted a pilot study with four people who have severe expressive and receptive aphasia where the investigators trialed the assessment and therapy protocol, and explored adapting the therapy for people with severe communication difficulties.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The Research Assistant will complete the psychosocial outcome measures at all time points in face to face interview format. The Research Assistant will be blinded to treatment allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have a diagnosis of ischaemic or haemorrhagic stroke
- •At least six months post stroke
- •18 years old or over
- •Presenting with aphasia as a result of the stroke. For those participants identified via United Kingdom National Health Service (two participant identification centers), this will be determined based on Speech and Language Therapist diagnosis. For participants recruited via the community, it will be based on their scores on the Frenchay Aphasia Screening Test (FAST). This test covers four major aspects of language: comprehension, expression, reading and writing. Aphasia is determined by published cut-off scores. Where a person has mild aphasia, such that they score as 'normal' on the FAST, but where the participant self-identifies as having aphasia, and this is confirmed by the clinical judgement of the Chief Investigator, they will be included.
Exclusion Criteria
- •Other diagnoses affecting cognition such as dementia or advanced Parkinson's Disease
- •Severe uncorrected visual or hearing problems that would impact on a person's capacity to take part in the intervention
- •Severe or potentially terminal co-morbidity on grounds of frailty
- •Currently receiving a psychological or psychiatric intervention
- •Non-fluent English speaker prior to the stroke based on self/family report
- •Do not have mental capacity to consent to take part in the trial
Arms & Interventions
Intervention: immediate SFBT
The Intervention arm will receive up to six Adapted Solution Focused Brief Therapy (SFBT) sessions immediately post randomisation. The sessions will be spaced over 3 months. Participants will also receive all usual care.
Intervention: Adapted Solution Focused Brief Therapy (Behavioral)
Intervention: delayed SFBT
The wait-list control arm will receive the same intervention (Adapted Solution Focused Brief Therapy, SFBT) as the intervention arm, but after a delay of six months. Participants will also receive all usual care.
Intervention: Adapted Solution Focused Brief Therapy (Behavioral)
Outcomes
Primary Outcomes
Warwick Edinburgh Mental Well-being Scale (WEMWBS)
Time Frame: 6 months post randomization
Measures mental well-being. 14 items, scores range from 14 to 70, with higher scores indicating greater overall mental well-being
Secondary Outcomes
- Warwick Edinburgh Mental Well-being Scale (WEMWBS) - measuring change(All participants will complete WEMWBS at baseline, pre-randomization (T1), 3 months post randomization (T2), 6 months post randomization (T3). The wait-list control arm will also be tested at 9 months post randomization (T4).)
- Communicative Participation Item Bank (CPIB) - measuring change(All participants will complete CPIB at baseline, pre-randomisation (T1), 3 months post randomisation (T2), 6 months post randomisation (T3). The wait-list control arm will also be tested at 9 months post randomisation (T4).)
- General Health Questionnaire-12 (GHQ-12) - measuring change(All participants will complete GHQ-12 at baseline, pre-randomisation (T1), 3 months post randomisation (T2), 6 months post randomisation (T3). The wait-list control arm will also be tested at 9 months post randomisation (T4).)
- Depression Intensity Scale Circles (DISCS) - measuring change(All participants will complete DISCS at baseline, pre-randomisation (T1), 3 months post randomisation (T2), 6 months post randomisation (T3). The wait-list control arm will also be tested at 9 months post randomisation (T4).)