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

A Remote Electronically Delivered Integrated Care Pathway for Adolescents With Major Depressive Disorder: A Feasibility Study

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.

Study Overview

• Status: Terminated
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Other: eCARIBOU

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Centre for Addiction and Mental Health
    • Toronto, Ontario, Canada, M6J 1H4
      • The Center for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Remote Electronically Delivered Integrated Care Pathway (ICP); 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.

Other: eCARIBOU; A 16 week remote electronically deliver Integrated Care Pathway (ICP) for adolescents (13-18 years old) with Major Depressive Disorder (MDD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Time it takes to recruit 12 participants to the study	6 months
Number of Psychiatry Appointments	Proportion of scheduled psychiatry appointments attended (number attended divided by 4 for each participant)	16 weeks
Number of iCBT Content Viewed	Proportion of online CBT videos viewed per participant (number viewed divided by 54)	16 weeks
Number of Health Coach Text Messages	Number of text messages the participant sent to the health coach (count data)	16 weeks
Fitbit Usage	Number of days the fitbit is worn and the percentage of data collected	16 weeks
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).	16 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	16 weeks
ICP Deviations	Frequency of deviations from the pathway and any documented reasons for deviations	16 weeks

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: York University
• Investigators: Principal Investigator: Darren Courtney, MD, Centre for Addiction and Mental Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): January 23, 2024

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Adolescent; Depression; Cognitive Behaviour Therapy; Tele-psychiatry; Measurement Based Care; e-mental health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 121/2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No