A Remote Electronically Delivered Integrated Care Pathway: A Feasibility Study

Major Depressive Disorder Clinical Trial

— eCARIBOU  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05086120
• Other study ID #: 121/2019-01
• Status: Terminated
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: January 23, 2024

Study information

• Verified date: March 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 23, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	The Center for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	York University

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

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