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Completed

NCT Number: NCT03439813

Treating Anxiety After Stroke (TASK)

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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Key information

Conditions

Anxiety Disorders Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Mental Disorders Nervous System Diseases Stroke Transient Ischemic Attack Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Edinburgh

Edinburgh, Midlothian, EH16 4SB, United Kingdom

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TASK-CBT

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

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.

Primary outcomes

  1. Feasibility of web-enabled self-recruitment

    Time frame: At 20 weeks

    Number of participants recruited per month

Secondary outcomes

  1. Unwanted effects arising from any of the TASK treatments

    Time frame: At 20 weeks

    % participants reported unwanted effects from allocated intervention

  2. Feasibility of electronic informed consent form

    Time frame: At 20 weeks

    % of participants completed electronic informed consent

  3. Feasibility of remote eligibility confirmation via electronic health records

    Time frame: At 20 weeks

    Time taken to confirm eligibility (in days): date of randomization - date of data request made

  4. Feasibility of assessing intervention fidelity

    Time frame: At 20 weeks

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

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

    Time frame: At 6 and 20 weeks

    % completed follow up surveys

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial

Acronym: TASK

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2018
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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