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Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke

Primary Purpose

Stroke, Depression, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guided internet delivered cognitive behavioural therapy
Stroke rehabilitation mental health education
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Depression, Anxiety, internet-delivered cognitive behaviour therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Stroke internet delivered cognitive behavioural therapy

    Stroke Rehabilitation Education

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in depression
    Measured by Patient Health Questionnaire - 9 Item (PHQ-9), higher scores indicate worse outcomes
    Change in anxiety
    Measured by Generalize Anxiety Disorder - 7 Item (GAD7)higher scores indicate worse outcomes

    Secondary Outcome Measures

    Change in quality of life symptoms
    Measured by VAS on the EuroQol-5D (EQ5D), higher scores indicate better outcomes
    Self-efficacy
    Measured by Self-Efficacy for managing Chronic Disease-6 (SEMCD), higher scores indicate better outcomes
    Change in perceived disability
    Measured by The World Health Organization Disability Assessment Schedule ,(WHODAS), higher scores indicate worse outcomes
    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.
    Treatment satisfaction
    Measured by Internet-CBT Treatment Satisfaction Measure, higher scores indicate greater satisfaction

    Full Information

    First Posted
    February 7, 2022
    Last Updated
    March 15, 2023
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05243615
    Brief Title
    Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke
    Official Title
    Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lawson Health Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Depression, Anxiety
    Keywords
    Stroke, Depression, Anxiety, internet-delivered cognitive behaviour therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stroke internet delivered cognitive behavioural therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Stroke Rehabilitation Education
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Guided internet delivered cognitive behavioural therapy
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stroke rehabilitation mental health education
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in depression
    Description
    Measured by Patient Health Questionnaire - 9 Item (PHQ-9), higher scores indicate worse outcomes
    Time Frame
    baseline, 10 weeks, 3 months
    Title
    Change in anxiety
    Description
    Measured by Generalize Anxiety Disorder - 7 Item (GAD7)higher scores indicate worse outcomes
    Time Frame
    baseline, 10 weeks, 3 months
    Secondary Outcome Measure Information:
    Title
    Change in quality of life symptoms
    Description
    Measured by VAS on the EuroQol-5D (EQ5D), higher scores indicate better outcomes
    Time Frame
    baseline, 10 weeks, 3 months
    Title
    Self-efficacy
    Description
    Measured by Self-Efficacy for managing Chronic Disease-6 (SEMCD), higher scores indicate better outcomes
    Time Frame
    baseline, 10 weeks, 3 months
    Title
    Change in perceived disability
    Description
    Measured by The World Health Organization Disability Assessment Schedule ,(WHODAS), higher scores indicate worse outcomes
    Time Frame
    baseline, 10 weeks, 3 months
    Title
    Treatment credibility
    Description
    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.
    Time Frame
    baseline, 10 weeks
    Title
    Treatment satisfaction
    Description
    Measured by Internet-CBT Treatment Satisfaction Measure, higher scores indicate greater satisfaction
    Time Frame
    baseline, 10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Swati Mehta, PhD
    Phone
    519-661-2111
    Ext
    42359
    Email
    swati.mehta@sjhc.london.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shannon Janzen
    Phone
    519-661-2111
    Ext
    41295
    Email
    shannon.janzen@sjhc.london.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Teasell, MD
    Organizational Affiliation
    Western University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Internet-delivered Cognitive Behavioural Therapy for Persons With Stroke

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