Adapted Solution Focused Therapy for People With Aphasia (SOFIA Trial)

NCT ID: NCT03245060

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2019-08-14

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.

For the feasibility trial (commencing October 2017) 32 participants will be recruited with any severity of aphasia, at least six months post stroke. Participants will be randomly assigned to the intervention group or wait-list control group. Both groups will be assessed by a Research Assistant blinded to treatment allocation on psychosocial outcome measures at T1 (baseline, prior to randomization), T2 (three months post randomization) and T3 (six months post randomization). Participants will also take part in in-depth interviews at T3 exploring their experiences of taking part in the project as well as complete a resource use questionnaire. All participants will receive all usual care, and up to six SFBT sessions spaced over three months delivered by Speech and Language Therapists. The intervention group will receive the therapy immediately post randomization, while the wait-list control group will be offered the intervention after T3. The wait-list control will additionally be reassessed at T4 (nine months post randomization). The investigators will also interview the trial clinicians, and the Local Collaborators at the two participant identification sites.

Results The feasibility of recruitment and retention of participants (including proportion who consent; rate of consent; attrition rates) will be assessed, as will treatment fidelity. Descriptive statistics for the clinical outcome measures will be presented, for the entire trial population and by trial arm, at each time point, with means and confidence intervals plotted over time. The proportion of missing data will also be reported. As part of the economic evaluation, the relevant costs and health gains will be presented by trial arm and the completeness of data collection methods and their acceptability will be assessed. Qualitative data on acceptability of the intervention and study procedures will be analysed using Framework Analysis.

Clinical Implications This trial has been designed to assess the acceptability of the intervention for people with varying presentations of aphasia, and the feasibility of conducting a successful definitive trial evaluating clinical and cost effectiveness in the future. Given the high levels of distress and isolation experienced by people living with aphasia, and the current poor evidence base, there is a pressing need to investigate effective psychosocial interventions. SFBT is potentially a relatively brief approach deliverable by Speech and Language Therapists.

Conditions

Aphasia; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Adapted Solution Focused Brief Therapy

Intervention Type: BEHAVIORAL

Solution Focused Brief Therapy is an approach to building positive change in a person's life. It builds up a picture of a client's preferred future (or how a person would like their life to be); encourages a person to notice positive signs of change; and explores personal resources, skills and resilience. In the present project, the therapy has been adapted so that it works well with people who have a language disability.

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.

Group Type: OTHER

Adapted Solution Focused Brief Therapy

Intervention Type: BEHAVIORAL

Solution Focused Brief Therapy is an approach to building positive change in a person's life. It builds up a picture of a client's preferred future (or how a person would like their life to be); encourages a person to notice positive signs of change; and explores personal resources, skills and resilience. In the present project, the therapy has been adapted so that it works well with people who have a language disability.

Interventions

Adapted Solution Focused Brief Therapy

Solution Focused Brief Therapy is an approach to building positive change in a person's life. It builds up a picture of a client's preferred future (or how a person would like their life to be); encourages a person to notice positive signs of change; and explores personal resources, skills and resilience. In the present project, the therapy has been adapted so that it works well with people who have a language disability.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

City, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Northcott, PhD

Role: PRINCIPAL_INVESTIGATOR

City, University of London

Locations

City, University of London

London, , United Kingdom

Countries

United Kingdom

References

Northcott S, Thomas S, James K, Simpson A, Hirani S, Barnard R, Hilari K. Solution Focused Brief Therapy in Post-Stroke Aphasia (SOFIA): feasibility and acceptability results of a feasibility randomised wait-list controlled trial. BMJ Open. 2021 Aug 18;11(8):e050308. doi: 10.1136/bmjopen-2021-050308.

Reference Type: DERIVED

PMID: 34408055 (View on PubMed)

Northcott S, Simpson A, Thomas S, Barnard R, Burns K, Hirani SP, Hilari K. "Now I Am Myself": Exploring How People With Poststroke Aphasia Experienced Solution-Focused Brief Therapy Within the SOFIA Trial. Qual Health Res. 2021 Sep;31(11):2041-2055. doi: 10.1177/10497323211020290. Epub 2021 Jun 15.

Reference Type: DERIVED

PMID: 34130554 (View on PubMed)

Other Identifiers

TSA Postdoc 2016/01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Staff/17-18/04

Identifier Type: -

Identifier Source: org_study_id