Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Feasibility of web-enabled self-recruitment
研究概览
简要总结
The TASK (Treating Anxiety after StroKe) trial is a feasibility randomized controlled trial. It aims to evaluate the feasibility of i) web-enabled trial procedures, and ii) the TASK intervention in stroke and TIA patients
详细描述
Anxiety after stroke and transient ischaemic attack (TIA) is common. It is distressing and potentially debilitating. Currently, post-stoke psychological care is inadequate. There is no definitive evidence to guide treatment of anxiety post-stroke.
The TASK intervention is a centralized model for delivering personalised therapy for treating anxiety post-stroke using telephone and web-technology.
The TASK intervention includes:
- Treatment website and telephone support
- Learning ways to overcome anxiety after stroke/'mini-stroke'
- Relaxation techniques
- Weekly online tasks
- Therapeutic videos
- Text reminders and participant record card
- Useful links to stroke resources and websites
The investigators designed the TASK trial to be web-enabled, so that it can be conducted entirely remotely.
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
Participant receives one of the two TASK interventions. Both are considered active interventions for anxiety.
Once started on the intervention participant may realise the type of intervention he has received, thus unblinding treatment allocation. Participants remain unaware of the contents of intervention given to the other group. Outcomes are self-completed by participants electronically to achieve assessor blinding.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above
- •A diagnosis of stroke (ischaemic, primary haemorrhagic) or TIA-probable, definite, or ocular
- •At least one month after being discharged to the community from clinic or hospital ward
- •Has anxiety symptoms
- •a. at least one anxiety symptom should be present on the 6-item anxiety screening questions derived from GAD-7 and modified Fear Questionnaire(ref).
- •Have capacity to give informed consent
- •Able to communicate in English on the telephone
- •Can access the internet via a computer/ tablet/ smartphone
- •Residents within NHS Lothian regions (EH postcodes and FK1)
排除标准
- •People already taking part in a clinical trial of treatment intended to improve psychosocial outcomes e.g. emotional distress, anxiety, depression, emotionalism, fatigue, social functioning, quality of life are excluded.
研究组 & 干预措施
TASK-CBT
Web and telephone-delivered cognitive behavioural therapy designed for anxiety after stroke and TIA. Six personalized telephone CBT sessions, one week apart by a trained and supervised medical professional using the TASK Therapist's Manual. Treatment website contains multimedia content to cover key CBT skills with weekly online tasks.
干预措施: TASK-CBT (Behavioral)
TASK-Relax
Web and telephone-supported relaxation therapy. Treatment website contains five relaxation exercises: i) audio- and visually-guided breathing exercise, ii) relaxing imagery and sounds, iii) music for relaxation, iv) audio-guided progressive muscle relaxation, and v) a selection of sounds of nature. Telephone instruction given and treatment website contains multimedia content to explain to participant how to practice relaxation regularly during the trial period.
干预措施: TASK-Relax (Behavioral)
结局指标
主要结局
Feasibility of web-enabled self-recruitment
时间窗: At 20 weeks
Number of participants recruited per month
次要结局
- Feasibility of assessing intervention fidelity(At 20 weeks)
- Unwanted effects arising from any of the TASK treatments(At 20 weeks)
- Feasibility of online self-completed surveys at data collection time points(At 6 and 20 weeks)
- Feasibility of electronic informed consent form(At 20 weeks)
- Feasibility of remote eligibility confirmation via electronic health records(At 20 weeks)