Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-05 @ 12:52 PM
Study NCT ID:
NCT03245060
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adapted Solution Focused Therapy for People With Aphasia (SOFIA Trial)
Sponsor:
City, University of London
Organization:
Study Overview
Official Title:
Adapted Solution Focused Brief Therapy in Post-stroke Aphasia (SOFIA Trial): a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOFIA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TSA Postdoc 2016/01 | OTHER_GRANT | The Stroke Association | View |