StrokeNCT05243615
Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke
A study testing Guided internet delivered cognitive behavioural therapy and Stroke rehabilitation mental health education in people with Stroke and Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Approximately 30% of people with stroke experience symptoms of depression. Many may benefit from access to mental health services that target unhelpful thoughts, such as cognitive behaviour therapy (CBT), but go untreated due to lack of access to specialized care, costs, remote location, or stigma related to seeking… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Depression, Anxiety
- What is being tested?
- Guided internet delivered cognitive behavioural therapy and Stroke rehabilitation mental health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Sep 2023
- 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
- 18 years of age or older;
- Canadian residents;
- diagnosed with a stroke at least 6 months ago;
- endorsing symptoms of depression (PHQ-9≥5); 5) suicide risk score <8 (Suicide Behaviours Questionnaire);
- speak and read English;
- able to access and be comfortable using computers and the internet;
- willing to provide a physician as an emergency contact.
Who cannot join
- significant cognitive impairment, a score of <21 on the Telephone Interview for Cognitive Status;
- aphasia, with significant language impairment;
- currently involved in another psychotherapeutic intervention;
- present with a severe mental health disorder requiring in-person therapy (e.g., severe suicidal ideation, severe substance abuse, a recent history of psychosis or mania).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke: Randomized Controlled Trial
Approximately 30% of people with stroke experience symptoms of depression. Many may benefit from access to mental health services that target unhelpful thoughts, such as cognitive behaviour therapy (CBT), but go untreated due to lack of access to specialized care, costs, remote location, or stigma related to seeking care. Internet Cognitive Behavioural Therapy (ICBT) may overcome these barriers. The stroke ICBT program teaches skills such as challenging unhelpful thoughts, memory and attention, managing related physical symptoms, and pacing through a mix of online learning and weekly contact with a trained Guide. While the program's content was found to be acceptable among individuals after stroke, the program's effectiveness still needs to be evaluated. Thus, the primary purpose of this study is to evaluate if the stroke ICBT program will improve symptoms of depression compared to an attention control group. Individuals in both groups will answer questions about themselves and their injury and describe symptoms of depression, quality of life, and health service use to evaluate its impact on people's wellbeing. The study results will be useful in determining if the ICBT program is effective and whether it should be part of routine clinical practice.
- Conditions
- Stroke, Depression, Anxiety
- Being tested
- Guided internet delivered cognitive behavioural therapy, Stroke rehabilitation mental health education
- Keywords
- Stroke, Depression, Anxiety, internet-delivered cognitive behaviour therapy
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided internet delivered cognitive behavioural therapyBehavioural
A 10-week internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a stroke. In addition to the online program, a Guide with experience delivering ICBT will provide support by email or phone call once a week. The Guide will spend approximately 15 minutes per week/per client.
Stroke rehabilitation mental health educationBehavioural
A 10-week stroke-specific rehabilitation education program for stroke patients in usual care at specialized stroke rehabilitation units. The lessons will include information on spinal cord injury rehabilitation: 1)stroke basics, 2)mental health after stroke, 3)pain after stroke, 4)understanding rehabilitation 5)summary of lessons through an online platform. A Guide will check in with participants once a week to answer any content-related questions. The Guide will spend approximately 15 minutes per week/per client.
| Study group | Role | What they receive |
|---|---|---|
| Stroke internet delivered cognitive behavioural therapy | Experimental | A 10-week internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a stroke. In addition to the online program, a Guide with experience delivering ICBT will provide support by email or phone call once a week. The Guide will spend approximately 15 minutes per week/per client. Receives: Behavioral: Guided internet delivered cognitive behavioural therapy |
| Stroke Rehabilitation Education | Active comparator | A 10-week stroke-specific rehabilitation education program for stroke patients in usual care at specialized stroke rehabilitation units. The lessons will include information on spinal cord injury rehabilitation: 1)stroke basics, 2)mental health after stroke, 3)pain after stroke, 4)understanding rehabilitation 5)summary of lessons through an online platform. A Guide will check in with participants once a week to answer any content-related questions. The Guide will spend approximately 15 minutes per week/per client. Receives: Behavioral: Stroke rehabilitation mental health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
Measured by Patient Health Questionnaire - 9 Item (PHQ-9), higher scores indicate worse outcomes
Measured: baseline, 10 weeks, 3 months
Change in anxiety
Measured by Generalize Anxiety Disorder - 7 Item (GAD7)higher scores indicate worse outcomes
Measured: baseline, 10 weeks, 3 months
Secondary outcomes (5)
Change in quality of life symptoms
Measured by VAS on the EuroQol-5D (EQ5D), higher scores indicate better outcomes
Measured: baseline, 10 weeks, 3 months
Self-efficacy
Measured by Self-Efficacy for managing Chronic Disease-6 (SEMCD), higher scores indicate better outcomes
Measured: baseline, 10 weeks, 3 months
Change in perceived disability
Measured by The World Health Organization Disability Assessment Schedule ,(WHODAS), higher scores indicate worse outcomes
Measured: baseline, 10 weeks, 3 months
Treatment credibility
Measured by Treatment Credibility Questionnaire (TCQ) which contains 4 items. The first three items range from 0-9 with higher scores indicating better outcome, and the fourth item ranges from 0-100%, with higher scores indicating greater improvement in functioning.
Measured: baseline, 10 weeks
Treatment satisfaction
Measured by Internet-CBT Treatment Satisfaction Measure, higher scores indicate greater satisfaction
Measured: baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startMar 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swati Mehta, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Robert Teasell, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243615
- Sponsor's protocol ID
- 12132
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05243615
- Acronym / sponsor ID
- 12132
- Conditions
- Stroke, Depression, Anxiety
- Keywords
- Stroke, Depression, Anxiety, internet-delivered cognitive behaviour therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 17 Feb 2022 (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.
Approximately 30% of people with stroke experience symptoms of depression. Many may benefit from access to mental health services that target unhelpful thoughts, such as cognitive behaviour therapy (CBT), but go untreated due to lack of access to specialized care, costs, remote location, or stigma related to seeking care. Internet Cognitive Behavioural Therapy (ICBT) may overcome these barriers. The stroke ICBT program teaches skills such as challenging unhelpful thoughts, memory and attention, managing related physical symptoms, and pacing through a mix of online learning and weekly contact with a trained Guide. While the program's content was found to be acceptable among individuals after stroke, the program's effectiveness still needs to be evaluated. Thus, the primary purpose of this study is to evaluate if the stroke ICBT program will improve symptoms of depression compared to an attention control group. Individuals in both groups will answer questions about themselves and their injury and describe symptoms of depression, quality of life, and health service use to evaluate its impact on people's wellbeing. The study results will be useful in determining if the ICBT program is effective and whether it should be part of routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke internet delivered cognitive behavioural therapy | Experimental | Behavioral: Guided internet delivered cognitive behavioural therapyA 10-week internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a stroke. In addition to the online program, a Guide with experience delivering ICBT will provide support by email or phone call once a week. The Guide will spend approximately 15 minutes per week/per client. |
| Stroke Rehabilitation Education | Active comparator | Behavioral: Stroke rehabilitation mental health educationA 10-week stroke-specific rehabilitation education program for stroke patients in usual care at specialized stroke rehabilitation units. The lessons will include information on spinal cord injury rehabilitation: 1)stroke basics, 2)mental health after stroke, 3)pain after stroke, 4)understanding rehabilitation 5)summary of lessons through an online platform. A Guide will check in with participants once a week to answer any content-related questions. The Guide will spend approximately 15 minutes per week/per client. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older;
- Canadian residents;
- diagnosed with a stroke at least 6 months ago;
- endorsing symptoms of depression (PHQ-9≥5); 5) suicide risk score <8 (Suicide Behaviours Questionnaire);
- speak and read English;
Key exclusion criteria (4 listed)
- significant cognitive impairment, a score of <21 on the Telephone Interview for Cognitive Status;
- aphasia, with significant language impairment;
- currently involved in another psychotherapeutic intervention;
- present with a severe mental health disorder requiring in-person therapy (e.g., severe suicidal ideation, severe substance abuse, a recent history of psychosis or mania).
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 |
|---|---|---|
| Guided internet delivered cognitive behavioural therapyA 10-week internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a stroke. In addition to the online program, a Guide with experience delivering ICBT will provide support by email or phone call once a week. The Guide will spend approximately 15 minutes per week/per client. | Behavioural | Stroke internet delivered cognitive behavioural therapy |
| Stroke rehabilitation mental health educationA 10-week stroke-specific rehabilitation education program for stroke patients in usual care at specialized stroke rehabilitation units. The lessons will include information on spinal cord injury rehabilitation: 1)stroke basics, 2)mental health after stroke, 3)pain after stroke, 4)understanding rehabilitation 5)summary of lessons through an online platform. A Guide will check in with participants once a week to answer any content-related questions. The Guide will spend approximately 15 minutes per week/per client. | Behavioural | Stroke Rehabilitation Education |
Primary outcome
Change in depression
Time frame: baseline, 10 weeks, 3 months
Measured by Patient Health Questionnaire - 9 Item (PHQ-9), higher scores indicate worse outcomes
Change in anxiety
Time frame: baseline, 10 weeks, 3 months
Measured by Generalize Anxiety Disorder - 7 Item (GAD7)higher scores indicate worse outcomes
5 secondary outcomes
Change in quality of life symptoms
Time frame: baseline, 10 weeks, 3 months
Self-efficacy
Time frame: baseline, 10 weeks, 3 months
Change in perceived disability
Time frame: baseline, 10 weeks, 3 months
Treatment credibility
Time frame: baseline, 10 weeks
Treatment satisfaction
Time frame: baseline, 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- 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.
Robert Teasell, MD principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing Guided internet delivered cognitive behavioural therapy and Stroke rehabilitation mental health education in people with Stroke and Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Swati Mehta, PhD (519-661-2111 ext. 42359, swati.mehta@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: baseline, 10 weeks, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2023.