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ICBT for Persons With Stroke

Primary Purpose

Stroke, Internet-Delivered Cognitive Behavioural Therapy, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-delivered Cognitive Behavioural Therapy
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adults ≥ 18 years
  • diagnosed with stroke
  • resident of Canada
  • access to a computer and the internet
  • cognitive capacity to read and understand the content of the program.

Exclusion Criteria:

  • High risk of suicide
  • Serious cognitive impairment or dementia (<21 on the Telephone Interview of Cognitive Status (TICS)
  • primary problems with psychosis, alcohol or drug problems, mania
  • Currently receiving active psychological treatment for anxiety or depression
  • Not present in Canada during treatment; 6) Concerns about online therapy
  • Physically unable to perform the tasks.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    10 week ICBT

    Arm Description

    CBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend ~15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.

    Outcomes

    Primary Outcome Measures

    Change in depression
    Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.

    Secondary Outcome Measures

    Change in anxiety
    Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater Severity of anxiety. Scores range from 0 to 21.
    Change in quality of life
    EuroQol five-dimension (EQ-5D) questionnaire. Every dimension of the EQ-5D-5L includes five answer levels, covering no problems (1) to extreme problems (5). Higher numbers indicates poorer quality of life.

    Full Information

    First Posted
    December 8, 2020
    Last Updated
    May 17, 2022
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04667754
    Brief Title
    ICBT for Persons With Stroke
    Official Title
    Internet Delivered Cognitive Behavioural Therapy (ICBT) for Persons With Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    July 2022 (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

    5. Study Description

    Brief Summary
    Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions, including stroke. The aim of the current study is to pilot a tailored ICBT program developed through a patient oriented approach to improve overall wellbeing among those with stroke living in the community.
    Detailed Description
    Background: Individuals with stroke can experience high levels of emotional distress leading to decreased quality of life and increased health care costs. Though mental health problems are prevalent and disabling, they often go untreated for various reasons, such as access to specialized care, rural and remote location, lack of time, or concerns about stigma related to seeking care. Internet delivered cognitive behaviour therapy (ICBT) overcomes barriers to face-to-face therapy by often reaching a much wider group of patients who experience unequal access to health care. The internet based program is based on cognitive behaviour therapy, which is an evidenced-based treatment that helps patients identify and modify thoughts and behaviours that contribute to their mental health concerns. ICBT has been shown to be effective in improving psychosocial outcomes such as depression and anxiety, along with disability and quality of life among persons with chronic health conditions. Rationale: Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions, including stroke. Objective: The aim of the current study is to pilot an ICBT program developed through a patient oriented approach to improve overall wellbeing among those with stroke Methods: In this project, an ICBT program for those with stroke developed through a patient oriented approach will be piloted amongst a small group of participants (n=20) to examine acceptability, feasibility, and limited efficacy. At the end of the program, participants will be asked to complete a brief semi-structured interview examining barriers and facilitators to the ICBT program. Participant feedback from the interviews will be used to further improve the ICBT program to meet the needs of the population. The results from the study will be used to guide larger studies to evaluate effectiveness of the program in a community setting. Anticipated Impact: Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those who have experienced stroke and mental health concerns.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Internet-Delivered Cognitive Behavioural Therapy, Depression, Anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    10 week ICBT
    Arm Type
    Experimental
    Arm Description
    CBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend ~15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet-delivered Cognitive Behavioural Therapy
    Intervention Description
    ICBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend ~15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.
    Primary Outcome Measure Information:
    Title
    Change in depression
    Description
    Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
    Time Frame
    Baseline to 3 months
    Secondary Outcome Measure Information:
    Title
    Change in anxiety
    Description
    Generalize Anxiety Disorder - 7 Item (GAD7). Higher total scores indicate greater Severity of anxiety. Scores range from 0 to 21.
    Time Frame
    Baseline to 3 months
    Title
    Change in quality of life
    Description
    EuroQol five-dimension (EQ-5D) questionnaire. Every dimension of the EQ-5D-5L includes five answer levels, covering no problems (1) to extreme problems (5). Higher numbers indicates poorer quality of life.
    Time Frame
    Baseline to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: adults ≥ 18 years diagnosed with stroke resident of Canada access to a computer and the internet cognitive capacity to read and understand the content of the program. Exclusion Criteria: High risk of suicide Serious cognitive impairment or dementia (<21 on the Telephone Interview of Cognitive Status (TICS) primary problems with psychosis, alcohol or drug problems, mania Currently receiving active psychological treatment for anxiety or depression Not present in Canada during treatment; 6) Concerns about online therapy Physically unable to perform the tasks.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Swati Mehta, PhD
    Phone
    519-685-8500
    Ext
    42359
    Email
    swati.mehta@sjhc.london.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandria Roa Agudelo
    Phone
    (519) 646-6100
    Ext
    x42696
    Email
    alexandria.roaagudelo@sjhc.london.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Swati Mehta, PhD
    Organizational Affiliation
    Lawson Health Research Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Robert Teasell, MD
    Organizational Affiliation
    St. Joseph's Health Care London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    ICBT for Persons With Stroke

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