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Treating Anxiety After Stroke (TASK) (TASK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439813
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

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

Condition or disease Intervention/treatment Phase
Anxiety Disorders Stroke Transient Ischemic Attack Behavioral: TASK-CBT Behavioral: TASK-Relax Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.

Primary Purpose: Treatment
Official Title: Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Feasibility of web-enabled self-recruitment [ Time Frame: At 20 weeks ]
    Number of participants recruited per month


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439813


Locations
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United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SB
Sponsors and Collaborators
University of Edinburgh
Investigators
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Principal Investigator: Yvonne Chun, MRCP University of Edinburgh
  Study Documents (Full-Text)

Documents provided by University of Edinburgh:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03439813    
Other Study ID Numbers: 2017/0253
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
stroke
transient ischemic attack
anxiety
psychotherapy
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Anxiety Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mental Disorders
Brain Ischemia