Treating Anxiety After Stroke (TASK)
- Conditions
- Anxiety DisordersStrokeTransient Ischemic Attack
- Interventions
- Behavioral: TASK-CBTBehavioral: TASK-Relax
- Registration Number
- NCT03439813
- Lead Sponsor
- University of Edinburgh
- Brief Summary
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
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
-
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
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Can access the internet via a computer/ tablet/ smartphone
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Residents within NHS Lothian regions (EH postcodes and FK1)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TASK-CBT 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. TASK-Relax 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.
- Primary Outcome Measures
Name Time Method Feasibility of web-enabled self-recruitment At 20 weeks Number of participants recruited per month
- Secondary Outcome Measures
Name Time Method Feasibility of online self-completed surveys at data collection time points At 6 and 20 weeks % completed follow up surveys
Unwanted effects arising from any of the TASK treatments At 20 weeks % participants reported unwanted effects from allocated intervention
Feasibility of assessing intervention fidelity At 20 weeks % of Therapist's record of content(s) delivered
Feasibility of electronic informed consent form At 20 weeks % of participants completed electronic informed consent
Feasibility of remote eligibility confirmation via electronic health records At 20 weeks Time taken to confirm eligibility (in days): date of randomization - date of data request made
Trial Locations
- Locations (1)
University of Edinburgh
🇬🇧Edinburgh, Midlothian, United Kingdom