Treating Anxiety After Stroke (TASK)

Study Overview
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Brief Summary
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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

Detailed Description
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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. In the TASK feasibility randomized controlled trial, the investigators aim to evaluate the feasibility of: i) web-enabled trial procedures: online recruitment, remote eligibility checking, electronic informed consent, online self-reported outcome surveys ii) feasibility of the TASK intervention in stroke and TIA patients This trial received a favourable opinion from the South East Scotland Research Ethics Committee (ref: 17/SS/0143)

Official Title
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Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial

Conditions
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Anxiety Disorders, Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Behavioral: TASK-CBT
* Behavioral: TASK-Relax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TASK-CBT<br>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. | Behavioral: TASK-CBT<br>* .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.<br>|
| Active Comparator: TASK-Relax<br>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. | Behavioral: TASK-Relax<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of web-enabled self-recruitment | Number of participants recruited per month | At 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unwanted effects arising from any of the TASK treatments | % participants reported unwanted effects from allocated intervention | At 20 weeks | 
| Feasibility of electronic informed consent form | % of participants completed electronic informed consent | At 20 weeks | 
| Feasibility of remote eligibility confirmation via electronic health records | Time taken to confirm eligibility (in days): date of randomization - date of data request made | At 20 weeks | 
| Feasibility of assessing intervention fidelity | % of Therapist's record of content(s) delivered | At 20 weeks | 
| Feasibility of online self-completed surveys at data collection time points | % completed follow up surveys | At 6 and 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, transient ischemic attack, anxiety, psychotherapy