A Remote Electronically Delivered Integrated Care Pathway: A Feasibility Study

NCT05086120 | Terminated

• 1 other identifier: 121/2019-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder

Keywords

Tele-psychiatry; Adolescent; Depression; Measurement Based Care; Cognitive Behaviour Therapy; e-mental health

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Remote Electronically Delivered Integrated Care Pathway (ICP)

EXPERIMENTAL

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

Interventions

eCARIBOU OTHER

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

Remote Electronically Delivered Integrated Care Pathway (ICP)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• York University: collaborator

Study Sites (2)

The Center for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 33688840 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Darren Courtney, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist with the Cundill Centre for Child and Youth Depression and a Staff Psychiatrist in the Youth Addictions and Concurrent Disorders Service

Model Details: Adolescents (age 13-18) with major depressive disorder.

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 20, 2021
• Study Start: January 4, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)