Treating Anxiety After Stroke (TASK)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2018-08-31

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

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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)

Conditions

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Anxiety Disorders Stroke Transient Ischemic Attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

TASK-CBT

Intervention Type BEHAVIORAL

.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

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.

Group Type ACTIVE_COMPARATOR

TASK-Relax

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No