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

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ClinicalTrials.gov Identifier: NCT03406052
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
Paul Ritvo, York University

Brief 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.

Condition or disease Intervention/treatment Phase
Disorder, Major Depressive Behavioral: Smartphone-Assisted MB-CBT Not Applicable

Detailed Description:

A high proportion (70%) of mental health problems appear before 25 yrs. and can become become long-standing, significant disorders that impair all life domains. Early signs of disorder left untreated is an acute problem for Canadian youth as 15-25 yrs is the most likely age-strata for diagnosable psychiatric disorders, substance dependencies and suicide. Progress in youth treatments that engage the tendencies of youth to respond to online internet contact are likely to be especially strategic.

In this randomized controlled trial (RCT) diagnosed depressed youth are treated with online mindfulness-based cognitive behavioural therapy (MB-CBT) and standard psychiatric care or just standard psychiatric care (as wait-list controls). Eligible subjects will be recruited from the wait-lists of the Centre for Addiction and Mental Health (CAMH), and from community-based practices and clinics proximal to CAMH. The consented 168 subjects will be from First Nations background (18-30 yrs) and from all other ethnic backgrounds, stratified into two intervention groups and two wait-list control groups.

Primary outcome is self reported depression using the Beck Depression Inventory II while secondary outcomes include self reported anxiety (Beck Anxiety Inventory), depression (Quick Inventory of Depressive Symptomatology, 24-item Hamilton Rating Scale for Depression (HRSD-24)), pain (Brief Pain Inventory) mindfulness (Five-Facet Mindfulness Questionnaire) and intervention costs.

If hypotheses are confirmed that youth can be effectively treated with online MB-CBT at reduced costs, effective treatment can be delivered to greater numbers with less geographic restriction.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Psychiatrists providing psychiatric care will be blinded to the group allocation of subjects under their treatment. One outcome assessor (who will conduct the 24-item Hamilton Rating Scale for Depression (HRSD-24) will be blinded. Investigators will be blinded.
Primary Purpose: Supportive Care
Official Title: An Innovative Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smartphone-Assisted MB-CBT
Online intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content
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).

No Intervention: Control
Standard psychiatric care



Primary Outcome Measures :
  1. Beck Depression Inventory II [ Time Frame: Baseline, 3 months, 6 months ]
    Change from baseline self report of symptoms of depression


Secondary Outcome Measures :
  1. Beck Anxiety Scale [ Time Frame: Baseline, 3 months, 6 months ]
    Change from baseline self report of anxiety symptoms

  2. Quick Inventory of Depressive Symptomatology [ Time Frame: Baseline, 3 months, 6 months ]
    Change from baseline self report of symptoms of depression

  3. Hamilton Depression Rating Scale (HRDS-24) [ Time Frame: Baseline, 3 months, 6 months ]
    Change from baseline interview and interviewer rating of symptoms of depression

  4. Five-Facet Mindfulness Questionnaire [ Time Frame: Baseline, 3 months, 6 months ]
    Change from baseline self report of mindfulness experience

  5. Brief Pain Inventory [ Time Frame: Baseline, 3 months, 6 months ]
    Change from baseline self report of pain intensity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 18-30 yrs
  • First Nations background or other ethnicity
  • BDI-II at mild-moderate levels (i.e., BDI-II score ≥ 14 and < 29 )
  • diagnosis of major depressive disorder
  • fluent in english
  • diagnosis by a CAMH physician and diagnosis confirmed by a MINI International Neuropsychiatric Interview

Exclusion Criteria

  • < 18 yrs and > 30 yrs
  • BDI-II in severe range ≥ 29 or < 14
  • does not qualify for diagnosis of major depressive disorder or diagnosis not confirmed by MINI International Neuropsychiatric Interview

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406052


Contacts
Contact: Paul G Ritvo, PhD 416-736-2100 ext 22396 pritvo@yorku.ca
Contact: Zafiris J Daskalakis, MD,PhD 416-535-8501 ext 34319 Jeff.Daskalakis@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Jeff Daskalakis, MD,PhD    4165358501 ext 4319    jeff.daskalakis@camh.ca   
Contact: Tania Jain, MSc    4165358501 ext 36347    tania.jain@camh.ca   
Sponsors and Collaborators
York University
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Paul G Ritvo, PhD York University

Publications of Results:

Responsible Party: Paul Ritvo, Professor, York University
ClinicalTrials.gov Identifier: NCT03406052     History of Changes
Other Study ID Numbers: Yorku
2016-115 ( Other Identifier: Centre for Addiction and Mental Health )
2017-154 ( Other Grant/Funding Number: Federal Development Program - S. Ontario )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms