Treating Anxiety After Stroke (TASK)

Stroke Clinical Trial

— TASK  

Official title:

Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439813
• Other study ID #: 2017/0253
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2018
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh	Midlothian

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of web-enabled self-recruitment	Number of participants recruited per month	At 20 weeks
Secondary	Unwanted effects arising from any of the TASK treatments	% participants reported unwanted effects from allocated intervention	At 20 weeks
Secondary	Feasibility of electronic informed consent form	% of participants completed electronic informed consent	At 20 weeks
Secondary	Feasibility of remote eligibility confirmation via electronic health records	Time taken to confirm eligibility (in days): date of randomization - date of data request made	At 20 weeks
Secondary	Feasibility of assessing intervention fidelity	% of Therapist's record of content(s) delivered	At 20 weeks
Secondary	Feasibility of online self-completed surveys at data collection time points	% completed follow up surveys	At 6 and 20 weeks

External Links

•   TASK Participant information