Anxiety DisordersTASKNCT03439813
Treating Anxiety After Stroke (TASK)
A study testing TASK-CBT and TASK-Relax in people with Anxiety Disorders and Stroke, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Stroke, Transient Ischemic Attack
- What is being tested?
- TASK-CBT and TASK-Relax
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2018to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh
Edinburgh, Midlothian, EH16 4SB
About this study
Official title: Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial
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
Read the 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:
- 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)
- Conditions
- Anxiety Disorders, Stroke, Transient Ischemic Attack
- Being tested
- TASK-CBT, TASK-Relax
- Keywords
- stroke, transient ischemic attack, anxiety, psychotherapy
- Medical subject headings
- Anxiety Disorders, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TASK-CBTBehavioural
.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-RelaxBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TASK-Relax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of web-enabled self-recruitment
Number of participants recruited per month
Measured: At 20 weeks
Secondary outcomes (5)
Unwanted effects arising from any of the TASK treatments
% participants reported unwanted effects from allocated intervention
Measured: At 20 weeks
Feasibility of electronic informed consent form
% of participants completed electronic informed consent
Measured: At 20 weeks
Feasibility of remote eligibility confirmation via electronic health records
Time taken to confirm eligibility (in days): date of randomization - date of data request made
Measured: At 20 weeks
Feasibility of assessing intervention fidelity
% of Therapist's record of content(s) delivered
Measured: At 20 weeks
Feasibility of online self-completed surveys at data collection time points
% completed follow up surveys
Measured: At 6 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start17 Jan 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yvonne Chun, MRCP, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439813
- Sponsor's protocol ID
- 2017/0253
- Acronym
- TASK
- Status last verified
- Oct 2018
- First submitted
- 16 Jan 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32576090Chun 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.
PubMed 30128164
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Anxiety After Stroke (TASK) Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03439813
- Acronym / sponsor ID
- TASK / 2017/0253
- Conditions
- Anxiety Disorders, Stroke, Transient Ischemic Attack
- Keywords
- stroke, transient ischemic attack, anxiety, psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TASK-CBT | Experimental | Behavioral: TASK-CBTWeb 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-Relax | Active comparator | Behavioral: TASK-RelaxWeb 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Have capacity to give informed consent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | TASK-CBT |
| TASK-RelaxWeb 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. | Behavioural | TASK-Relax |
Primary outcome
Feasibility of web-enabled self-recruitment
Time frame: At 20 weeks
Number of participants recruited per month
5 secondary outcomes
Unwanted effects arising from any of the TASK treatments
Time frame: At 20 weeks
Feasibility of electronic informed consent form
Time frame: At 20 weeks
Feasibility of remote eligibility confirmation via electronic health records
Time frame: At 20 weeks
Feasibility of assessing intervention fidelity
Time frame: At 20 weeks
Feasibility of online self-completed surveys at data collection time points
Time frame: At 6 and 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 32576090Chun 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.
- Derived from this study: PubMed 30128164Chun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Chun, MRCP principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TASK-CBT and TASK-Relax in people with Anxiety Disorders and Stroke, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of web-enabled self-recruitment (time frame: At 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439813, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.