Clinical trial NCT03439813: Treating Anxiety After Stroke (TASK)
Official title: Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Stroke
Transient Ischemic Attack
Keywords: stroke
transient ischemic attack
anxiety
psychotherapy
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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.

Primary outcomes:
measure: Feasibility of web-enabled self-recruitment
timeFrame: At 20 weeks
Secondary outcomes:
measure: Unwanted effects arising from any of the TASK treatments
timeFrame: At 20 weeks
measure: Feasibility of electronic informed consent form
timeFrame: At 20 weeks
measure: Feasibility of remote eligibility confirmation via electronic health records
timeFrame: At 20 weeks
measure: Feasibility of assessing intervention fidelity
timeFrame: At 20 weeks
measure: Feasibility of online self-completed surveys at data collection time points
timeFrame: At 6 and 20 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
state: Midlothian
Study officials:
affiliation: University of Edinburgh
name: Yvonne Chun, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.