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Treating Anxiety After Stroke (TASK) (TASK)

Primary Purpose

Anxiety Disorders, Stroke, Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
TASK-CBT
TASK-Relax
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring stroke, transient ischemic attack, anxiety, psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TASK-CBT

TASK-Relax

Arm 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.

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.

Outcomes

Primary Outcome Measures

Feasibility of web-enabled self-recruitment
Number of participants recruited per month

Secondary Outcome Measures

Unwanted effects arising from any of the TASK treatments
% participants reported unwanted effects from allocated intervention
Feasibility of electronic informed consent form
% of participants completed electronic informed consent
Feasibility of remote eligibility confirmation via electronic health records
Time taken to confirm eligibility (in days): date of randomization - date of data request made
Feasibility of assessing intervention fidelity
% of Therapist's record of content(s) delivered
Feasibility of online self-completed surveys at data collection time points
% completed follow up surveys

Full Information

First Posted
January 16, 2018
Last Updated
October 10, 2018
Sponsor
University of Edinburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03439813
Brief Title
Treating Anxiety After Stroke (TASK)
Acronym
TASK
Official Title
Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Stroke, Transient Ischemic Attack
Keywords
stroke, transient ischemic attack, anxiety, psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Chun, MRCP
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Edinburgh
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32576090
Citation
Chun HY, Carson AJ, Tsanas A, Dennis MS, Mead GE, Calabria C, Whiteley WN. Telemedicine Cognitive Behavioral Therapy for Anxiety After Stroke: Proof-of-Concept Randomized Controlled Trial. Stroke. 2020 Aug;51(8):2297-2306. doi: 10.1161/STROKEAHA.120.029042. Epub 2020 Jun 24.
Results Reference
derived
PubMed Identifier
30128164
Citation
Chun HY, Carson AJ, Dennis MS, Mead GE, Whiteley WN. Treating anxiety after stroke (TASK): the feasibility phase of a novel web-enabled randomised controlled trial. Pilot Feasibility Stud. 2018 Aug 14;4:139. doi: 10.1186/s40814-018-0329-x. eCollection 2018.
Results Reference
derived

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Treating Anxiety After Stroke (TASK)

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