Clinical trial NCT05086120: A Remote Electronically Delivered Integrated Care Pathway: A Feasibility Study
Official title: A Remote Electronically Delivered Integrated Care Pathway for Adolescents With Major Depressive Disorder: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Tele-psychiatry
Adolescent
Depression
Measurement Based Care
Cognitive Behaviour Therapy
e-mental health
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: York University
First posted: 2021-10-20
Enrollment: 1
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adolescents (age 13-18) with major depressive disorder.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment
timeFrame: 6 months
measure: Number of Psychiatry Appointments
timeFrame: 16 weeks
measure: Number of iCBT Content Viewed
timeFrame: 16 weeks
measure: Number of Health Coach Text Messages
timeFrame: 16 weeks
measure: Fitbit Usage
timeFrame: 16 weeks
measure: Psychiatric Management
timeFrame: 16 weeks
measure: Youth's Experience with eCARIBOU
timeFrame: 16 weeks
measure: ICP Deviations
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Center for Addiction and Mental Health
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Darren Courtney, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.