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A Remote Electronically Delivered Integrated Care Pathway: A Feasibility Study (eCARIBOU)

Primary Purpose

Major Depressive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eCARIBOU
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Tele-psychiatry, Adolescent, Depression, Measurement Based Care, Cognitive Behaviour Therapy, e-mental health

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 13-18 years old at baseline
  • Mood and Feelings Questionnaire - Childhood, long version (MFQ) score of ≥22
  • Diagnosis of Major Depressive Disorder by impression from the referring psychiatrist and confirmed using the KSADS
  • Internet access at home
  • Access to a smartphone for personal and private use, with an associated standard data plan (ie. greater than or equal to 500 MB/month)
  • Able to speak and read English fluently

Exclusion Criteria:

  • Individuals that arecurrently receiving structured psychotherapy
  • Clinically significant suicidal ideation that is defined as 'imminent intent' or attempted suicide in the past 6 months
  • Co-morbid diagnosis of borderline personality disorder (as assessed by the Childhood Interview for Borderline Personality Disorder) (Zanarini, 2003), schizophrenia, bipolar disorder, moderate-to-severe eating disorder, obsessive compulsive disorder and/or severe alcohol/substance use disorder in the past 3 months
  • Youth with known or clinically suspected intellectual disability or autism spectrum disorder
  • Youth who are not able to provide informed consent for any other reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Remote Electronically Delivered Integrated Care Pathway (ICP)

    Arm Description

    The remote electronically-delivered ICP (also known as eCARIBOU) will consist of psychiatry appointments through telemedicine every 4 weeks over 16 weeks, where the youth is at home. Prior to these appointments, measures (i.e., Mood and Feelings Questionnaire - MFQ) will be sent to the youth to be completed. Change in measure scores will be reviewed collaboratively between the psychiatrist and the youth to assist in making treatment decisions. The medication algorithm in the in-person ICP will be used to guide these decisions. The psychiatrist will also administer the Columbia Suicide Severity Rating Scale (C-SSRS) at each telepsychiatry appointment to monitor risk. Concurrently, youth will be offered internet-based Cognitive Behavioural Therapy (iCBT) and health-coaching via text.

    Outcomes

    Primary Outcome Measures

    Recruitment
    Time it takes to recruit 12 participants to the study
    Number of Psychiatry Appointments
    Proportion of scheduled psychiatry appointments attended (number attended divided by 4 for each participant)
    Number of iCBT Content Viewed
    Proportion of online CBT videos viewed per participant (number viewed divided by 54)
    Number of Health Coach Text Messages
    Number of text messages the participant sent to the health coach (count data)
    Fitbit Usage
    Number of days the fitbit is worn and the percentage of data collected
    Psychiatric Management
    Number of events involving of self-harm behaviour/suicidal ideation that required acute psychiatric management (where the study psychiatrist needs to communicate with the youth and/or family members outside of regular appointments every 4 weeks).
    Youth's Experience with eCARIBOU
    Qualitative Interview feedback from youth pertaining to the intervention - including ease of use, content relevance, level of engagement with the intervention
    ICP Deviations
    Frequency of deviations from the pathway and any documented reasons for deviations

    Secondary Outcome Measures

    Full Information

    First Posted
    October 8, 2021
    Last Updated
    December 7, 2021
    Sponsor
    Centre for Addiction and Mental Health
    Collaborators
    York University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05086120
    Brief Title
    A Remote Electronically Delivered Integrated Care Pathway: A Feasibility Study
    Acronym
    eCARIBOU
    Official Title
    A Remote Electronically Delivered Integrated Care Pathway for Adolescents With Major Depressive Disorder: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 4, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre for Addiction and Mental Health
    Collaborators
    York University

    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
    This is a one-armed observational study and feasibility trial of a remote electronically-delivered integrated care pathway for the treatment of adolescents. Eligible participants are between the ages of 13 and 18, inclusive, who have a primary diagnosis of major depressive disorder. Outcomes of interest are recruitment rates and participation in pathway components, including: appointments, measure-completion and use of electronically-delivered cognitive behavioural therapy.
    Detailed Description
    Introduction: Depression is common and debilitating in the adolescent age range. Geography or other logistical barriers may prevent youth from accessing care. Progress in the treatment of youth that uses their tendencies to engage in electronically mediated contacts (e.g., text, online videos, and livestream video chat) can strategically address depressive disorders to overcome these barriers. Methods: The Principal Investigator will conduct a pilot single-arm trial to assess the feasibility of a 16-week remote electronically delivered integrated care pathway (ICP) for the treatment of adolescents (age 13-18) with major depressive disorder. CBT components being delivered has been tested in the age 18-30 with depression. The ICP includes: tele-psychiatry appointments, online measurement-based care, internet-based cognitive behavioural therapy combined with mindfulness training, and text-based health coaching. Eligible subjects will be recruited from Child, Youth and Family services at the Centre for Addiction and Mental Health. The Principal Investigator aims to recruit 12 participants. Outcomes: Feasibility outcomes are of the primary interest; namely, recruitment rates, proportion of psychiatry appointments attended, proportion of self-report measures completed, proportion of online CBT videos viewed, number of text-exchanges between youth and health coaches, physical activity levels and qualitative feedback from youth about their experiences. Primary clinical outcomes will be described via self-reported depressive symptoms using the Mood and Feelings Questionnaire. Secondary outcomes include self-reported anxiety (anxiety-related subscales of the Revised Children's Anxiety and Depression Scale) and function (Youth Columbia Impairment Scale). The Principal Investigator will also measure self-injurious thoughts and behaviours using the Columbia Suicide Severity Rating Scale. Discussion: If results confirm hypotheses that youth can be feasibly treated with a remote electronically delivered ICP, further efficacy testing may be performed to assess this as a viable option for service delivery that reduces barriers to care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Tele-psychiatry, Adolescent, Depression, Measurement Based Care, Cognitive Behaviour Therapy, e-mental health

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Adolescents (age 13-18) with major depressive disorder.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Remote Electronically Delivered Integrated Care Pathway (ICP)
    Arm Type
    Experimental
    Arm Description
    The remote electronically-delivered ICP (also known as eCARIBOU) will consist of psychiatry appointments through telemedicine every 4 weeks over 16 weeks, where the youth is at home. Prior to these appointments, measures (i.e., Mood and Feelings Questionnaire - MFQ) will be sent to the youth to be completed. Change in measure scores will be reviewed collaboratively between the psychiatrist and the youth to assist in making treatment decisions. The medication algorithm in the in-person ICP will be used to guide these decisions. The psychiatrist will also administer the Columbia Suicide Severity Rating Scale (C-SSRS) at each telepsychiatry appointment to monitor risk. Concurrently, youth will be offered internet-based Cognitive Behavioural Therapy (iCBT) and health-coaching via text.
    Intervention Type
    Other
    Intervention Name(s)
    eCARIBOU
    Intervention Description
    A 16 week remote electronically deliver Integrated Care Pathway (ICP) for adolescents (13-18 years old) with Major Depressive Disorder (MDD).
    Primary Outcome Measure Information:
    Title
    Recruitment
    Description
    Time it takes to recruit 12 participants to the study
    Time Frame
    6 months
    Title
    Number of Psychiatry Appointments
    Description
    Proportion of scheduled psychiatry appointments attended (number attended divided by 4 for each participant)
    Time Frame
    16 weeks
    Title
    Number of iCBT Content Viewed
    Description
    Proportion of online CBT videos viewed per participant (number viewed divided by 54)
    Time Frame
    16 weeks
    Title
    Number of Health Coach Text Messages
    Description
    Number of text messages the participant sent to the health coach (count data)
    Time Frame
    16 weeks
    Title
    Fitbit Usage
    Description
    Number of days the fitbit is worn and the percentage of data collected
    Time Frame
    16 weeks
    Title
    Psychiatric Management
    Description
    Number of events involving of self-harm behaviour/suicidal ideation that required acute psychiatric management (where the study psychiatrist needs to communicate with the youth and/or family members outside of regular appointments every 4 weeks).
    Time Frame
    16 weeks
    Title
    Youth's Experience with eCARIBOU
    Description
    Qualitative Interview feedback from youth pertaining to the intervention - including ease of use, content relevance, level of engagement with the intervention
    Time Frame
    16 weeks
    Title
    ICP Deviations
    Description
    Frequency of deviations from the pathway and any documented reasons for deviations
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 13-18 years old at baseline Mood and Feelings Questionnaire - Childhood, long version (MFQ) score of ≥22 Diagnosis of Major Depressive Disorder by impression from the referring psychiatrist and confirmed using the KSADS Internet access at home Access to a smartphone for personal and private use, with an associated standard data plan (ie. greater than or equal to 500 MB/month) Able to speak and read English fluently Exclusion Criteria: Individuals that arecurrently receiving structured psychotherapy Clinically significant suicidal ideation that is defined as 'imminent intent' or attempted suicide in the past 6 months Co-morbid diagnosis of borderline personality disorder (as assessed by the Childhood Interview for Borderline Personality Disorder) (Zanarini, 2003), schizophrenia, bipolar disorder, moderate-to-severe eating disorder, obsessive compulsive disorder and/or severe alcohol/substance use disorder in the past 3 months Youth with known or clinically suspected intellectual disability or autism spectrum disorder Youth who are not able to provide informed consent for any other reason
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michelle U Ferreira, MEd
    Phone
    16472204432
    Email
    michelle.ferreira@camh.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bahar Amani, PhD
    Email
    bahar.amani@camh.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Darren Courtney, MD
    Organizational Affiliation
    Centre for Addiction and Mental Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33688840
    Citation
    Ritvo P, Knyahnytska Y, Pirbaglou M, Wang W, Tomlinson G, Zhao H, Linklater R, Bai S, Kirk M, Katz J, Harber L, Daskalakis Z. Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 10;23(3):e24380. doi: 10.2196/24380.
    Results Reference
    background

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    A Remote Electronically Delivered Integrated Care Pathway: A Feasibility Study

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