Treating Anxiety After Stroke (TASK)

University of Edinburgh

Status: Completed

Conditions: Stroke; Transient Ischemic Attack; Anxiety Disorders

Treatments: Behavioral: TASK-CBT; Behavioral: TASK-Relax

Study type: Interventional

Funder types: Other

Identifiers

NCT03439813

2017/0253

Details and patient eligibility

About

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

Full 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)

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

TASK-CBT

Experimental group

Description:

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.

Treatment:

Behavioral: TASK-CBT

TASK-Relax

Active Comparator group

Description:

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.

Treatment:

Behavioral: TASK-Relax