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

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

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.

Study Overview

• Status: Suspended
• Conditions: Disorder, Major Depressive
• Intervention / Treatment: Behavioral: Smartphone-Assisted MB-CBT

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
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J 1H4
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory II	Change from baseline self report of symptoms of depression	Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Anxiety Scale	Change from baseline self report of anxiety symptoms	Baseline, 3 months, 6 months
Quick Inventory of Depressive Symptomatology	Change from baseline self report of symptoms of depression	Baseline, 3 months, 6 months
Hamilton Depression Rating Scale (HRDS-24)	Change from baseline interview and interviewer rating of symptoms of depression	Baseline, 3 months, 6 months
Five-Facet Mindfulness Questionnaire	Change from baseline self report of mindfulness experience	Baseline, 3 months, 6 months
Brief Pain Inventory	Change from baseline self report of pain intensity	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: York University
• Collaborators: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Paul G Ritvo, PhD, York University

Publications and helpful links

General Publications

• Guglietti CL, Daskalakis ZJ, Radhu N, Fitzgerald PB, Ritvo P. Meditation-related increases in GABAB modulated cortical inhibition. Brain Stimul. 2013 May;6(3):397-402. doi: 10.1016/j.brs.2012.08.005. Epub 2012 Sep 7.
• Radhu N, Daskalakis ZJ, Guglietti CL, Farzan F, Barr MS, Arpin-Cribbie CA, Fitzgerald PB, Ritvo P. Cognitive behavioral therapy-related increases in cortical inhibition in problematic perfectionists. Brain Stimul. 2012 Jan;5(1):44-54. doi: 10.1016/j.brs.2011.01.006. Epub 2011 Feb 5.
• Wayne N, Perez DF, Kaplan DM, Ritvo P. Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial. J Med Internet Res. 2015 Oct 5;17(10):e224. doi: 10.2196/jmir.4871.
• Azam MA, Katz J, Fashler SR, Changoor T, Azargive S, Ritvo P. Heart rate variability is enhanced in controls but not maladaptive perfectionists during brief mindfulness meditation following stress-induction: A stratified-randomized trial. Int J Psychophysiol. 2015 Oct;98(1):27-34. doi: 10.1016/j.ijpsycho.2015.06.005. Epub 2015 Jun 25.
• Arpin-Cribbie C, Irvine J, Ritvo P. Web-based cognitive-behavioral therapy for perfectionism: a randomized controlled trial. Psychother Res. 2012;22(2):194-207. doi: 10.1080/10503307.2011.637242. Epub 2011 Nov 28.
• Azam MA, Katz J, Mohabir V, Ritvo P. Individuals with tension and migraine headaches exhibit increased heart rate variability during post-stress mindfulness meditation practice but a decrease during a post-stress control condition - A randomized, controlled experiment. Int J Psychophysiol. 2016 Dec;110:66-74. doi: 10.1016/j.ijpsycho.2016.10.011. Epub 2016 Oct 18.
• Pludwinski S, Ahmad F, Wayne N, Ritvo P. Participant experiences in a smartphone-based health coaching intervention for type 2 diabetes: A qualitative inquiry. J Telemed Telecare. 2016 Apr;22(3):172-8. doi: 10.1177/1357633X15595178. Epub 2015 Jul 21.
• Croarkin PE, Levinson AJ, Daskalakis ZJ. Evidence for GABAergic inhibitory deficits in major depressive disorder. Neurosci Biobehav Rev. 2011 Jan;35(3):818-25. doi: 10.1016/j.neubiorev.2010.10.002. Epub 2010 Oct 12.
• Levinson AJ, Fitzgerald PB, Favalli G, Blumberger DM, Daigle M, Daskalakis ZJ. Evidence of cortical inhibitory deficits in major depressive disorder. Biol Psychiatry. 2010 Mar 1;67(5):458-64. doi: 10.1016/j.biopsych.2009.09.025. Epub 2009 Nov 17.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Anticipated): May 30, 2019

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 21, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No