Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders
NCT ID: NCT03406052
Last Updated: 2019-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
168 participants
INTERVENTIONAL
2018-01-19
2019-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Smartphone-Assisted MB-CBT
Online intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content
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).
Control
Standard psychiatric care
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
30 Years
ALL
No
Sponsors
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Centre for Addiction and Mental Health
OTHER
York University
OTHER
Responsible Party
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Paul Ritvo
Professor
Principal Investigators
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Paul G Ritvo, PhD
Role: PRINCIPAL_INVESTIGATOR
York University
Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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References
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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.
Walters C, Gratzer D, Dang K, Laposa J, Knyahnytska Y, Ortiz A, Gonzalez-Torres C, Moore LP, Chen S, Ma C, Daskalakis Z, Ritvo P. The Use of Text Messaging as an Adjunct to Internet-Based Cognitive Behavioral Therapy for Major Depressive Disorder in Youth: Secondary Analysis. JMIR Form Res. 2024 May 31;8:e40275. doi: 10.2196/40275.
Dang K, Ritvo P, Katz J, Gratzer D, Knyahnytska Y, Ortiz A, Walters C, Attia M, Gonzalez-Torres C, Lustig A, Daskalakis Z. The Role of Daily Steps in the Treatment of Major Depressive Disorder: Secondary Analysis of a Randomized Controlled Trial of a 6-Month Internet-Based, Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth. Interact J Med Res. 2023 Dec 8;12:e46419. doi: 10.2196/46419.
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.
Other Identifiers
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2016-115
Identifier Type: OTHER
Identifier Source: secondary_id
2017-154
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Yorku
Identifier Type: -
Identifier Source: org_study_id
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