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Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders

NCT03406052 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-04-23

No results posted yet for this study

Summary

Randomized controlled trial (RCT) comparing youth diagnosed with major depressive disorder treated with online mindfulness-based cognitive behavioural therapy vs. standard psychiatric care (as wait-list controls). Eligible subjects will be recruited from the wait-lists of the Centre for Addiction and Mental Health. N = 168 subjects will consist of youth from First Nations background (18-30 yrs) and youth from all other ethnic backgrounds stratified to two intervention groups and two wait-list control groups consisting of 50% First Nations youth and 50% youth of all other ethnic backgrounds.

Conditions

  • Disorder, Major Depressive

Interventions

BEHAVIORAL

Smartphone-Assisted MB-CBT

Experimental subjects will receive a mindfulness-based CBT online software program workbook (in collaboration with Nex J Systems, Inc.) accessible online. Exposure to and interaction with the online workbook is combined with health coaching (duration of 24 total hours) primarily delivered in phone and software interactions. In addition, each participant will be given a Fitbit-HR Charge, a wearable bracelet that assesses physical steps and 24 hour heart rate in 5 second (averaged) durations (with related access to software that permits daily tracking).

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    collaborator OTHER

  • York University

    lead OTHER

Principal Investigators

  • Paul G Ritvo, PhD · York University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2019-03-31
Completion
2019-05-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03406052 on ClinicalTrials.gov