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临床试验/NCT03245060
NCT03245060已完成不适用

Adapted Solution Focused Brief Therapy in Post-stroke Aphasia (SOFIA Trial): a Feasibility Study

City, University of London2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Warwick Edinburgh Mental Well-being Scale (WEMWBS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

结局指标

主要结局

Warwick Edinburgh Mental Well-being Scale (WEMWBS)

时间窗: 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

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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