Treating Anxiety After Stroke (TASK)

University of Edinburgh27 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anxiety Disorders Stroke Transient Ischemic Attack

Interventions

TASK-CBTBEHAVIORAL

.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-RelaxBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 or above 2. A diagnosis of stroke (ischaemic, primary haemorrhagic) or TIA-probable, definite, or ocular 3. At least one month after being discharged to the community from clinic or hospital ward 4. 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). 5. Have capacity to give informed consent 6. Able to communicate in English on the telephone 7. Can access the internet via a computer/ tablet/ smartphone 8. Residents within NHS Lothian regions (EH postcodes and FK1) Exclusion Criteria: 9. 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.

Locations (1)

University of Edinburgh

Edinburgh, Midlothian, United Kingdom

Outcomes

Primary Outcomes

Feasibility of web-enabled self-recruitment

Number of participants recruited per month

Time frame: At 20 weeks

Secondary Outcomes

Unwanted effects arising from any of the TASK treatments

% participants reported unwanted effects from allocated intervention

Time frame: At 20 weeks

Feasibility of electronic informed consent form

% of participants completed electronic informed consent

Time frame: 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

Time frame: At 20 weeks

Feasibility of assessing intervention fidelity

% of Therapist's record of content(s) delivered

Time frame: At 20 weeks

Feasibility of online self-completed surveys at data collection time points

% completed follow up surveys

Time frame: At 6 and 20 weeks

Data from ClinicalTrials.gov

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