Treating Anxiety After Stroke (TASK)

NCT03439813 | Completed

• 1 other identifier: 2017/0253
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety Disorders; Stroke; Transient Ischemic Attack

Keywords

stroke; transient ischemic attack; anxiety; psychotherapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of web-enabled self-recruitment

  Number of participants recruited per month

  At 20 weeks

Secondary Outcomes (5)

• Unwanted effects arising from any of the TASK treatments

  At 20 weeks

• Feasibility of electronic informed consent form

  At 20 weeks

• Feasibility of remote eligibility confirmation via electronic health records

  At 20 weeks

• Feasibility of assessing intervention fidelity

  At 20 weeks

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

  At 6 and 20 weeks

Study Arms (2)

TASK-CBT

EXPERIMENTAL

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

TASK-Relax

ACTIVE COMPARATOR

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

Interventions

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-CBT

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.

TASK-Relax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH16 4SB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32576090 DERIVED

• 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.

  PMID: 30128164 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Yvonne Chun, MRCP

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: February 20, 2018
• Study Start: January 17, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)