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

Primary Purpose

Disorder, Major Depressive

Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Smartphone-Assisted MB-CBT
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Disorder, Major Depressive

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smartphone-Assisted MB-CBT

Control

Arm Description

Online intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content

Standard psychiatric care

Outcomes

Primary Outcome Measures

Beck Depression Inventory II
Change from baseline self report of symptoms of depression

Secondary Outcome Measures

Beck Anxiety Scale
Change from baseline self report of anxiety symptoms
Quick Inventory of Depressive Symptomatology
Change from baseline self report of symptoms of depression
Hamilton Depression Rating Scale (HRDS-24)
Change from baseline interview and interviewer rating of symptoms of depression
Five-Facet Mindfulness Questionnaire
Change from baseline self report of mindfulness experience
Brief Pain Inventory
Change from baseline self report of pain intensity

Full Information

First Posted
December 4, 2017
Last Updated
April 21, 2019
Sponsor
York University
Collaborators
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03406052
Brief Title
Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders
Official Title
An Innovative Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Suspended
Why Stopped
New funding required
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
May 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder, Major Depressive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone-Assisted MB-CBT
Arm Type
Experimental
Arm Description
Online intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard psychiatric care
Intervention Type
Behavioral
Intervention Name(s)
Smartphone-Assisted MB-CBT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Beck Depression Inventory II
Description
Change from baseline self report of symptoms of depression
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Beck Anxiety Scale
Description
Change from baseline self report of anxiety symptoms
Time Frame
Baseline, 3 months, 6 months
Title
Quick Inventory of Depressive Symptomatology
Description
Change from baseline self report of symptoms of depression
Time Frame
Baseline, 3 months, 6 months
Title
Hamilton Depression Rating Scale (HRDS-24)
Description
Change from baseline interview and interviewer rating of symptoms of depression
Time Frame
Baseline, 3 months, 6 months
Title
Five-Facet Mindfulness Questionnaire
Description
Change from baseline self report of mindfulness experience
Time Frame
Baseline, 3 months, 6 months
Title
Brief Pain Inventory
Description
Change from baseline self report of pain intensity
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G Ritvo, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23022436
Citation
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.
Results Reference
result
PubMed Identifier
22037137
Citation
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.
Results Reference
result
PubMed Identifier
26441467
Citation
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.
Results Reference
result
PubMed Identifier
26116778
Citation
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.
Results Reference
result
PubMed Identifier
22122217
Citation
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.
Results Reference
result
PubMed Identifier
27769879
Citation
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.
Results Reference
result
PubMed Identifier
26199275
Citation
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.
Results Reference
result
PubMed Identifier
20946914
Citation
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.
Results Reference
result
PubMed Identifier
19922906
Citation
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.
Results Reference
result
PubMed Identifier
33688840
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.
Results Reference
derived

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

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