Anxiety Disorders, Stroke, Transient Ischemic Attack
Conditions
Keywords
stroke, transient ischemic attack, anxiety, psychotherapy
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)
Interventions
BEHAVIORALTASK-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.
BEHAVIORALTASK-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.
Sponsors
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of web-enabled self-recruitment | At 20 weeks | Number of participants recruited per month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unwanted effects arising from any of the TASK treatments | At 20 weeks | % participants reported unwanted effects from allocated intervention |
| Feasibility of electronic informed consent form | At 20 weeks | % of participants completed electronic informed consent |
| Feasibility of remote eligibility confirmation via electronic health records | At 20 weeks | Time taken to confirm eligibility (in days): date of randomization - date of data request made |
| Feasibility of assessing intervention fidelity | At 20 weeks | % of Therapist's record of content(s) delivered |
| Feasibility of online self-completed surveys at data collection time points | At 6 and 20 weeks | % completed follow up surveys |
Countries
United Kingdom
Outcome results
None listed