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Disorder, Major DepressiveNCT03406052

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

A study testing Smartphone-Assisted MB-CBT in people with Disorder, Major Depressive, run by York University at 1 site in Canada.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Disorder, Major Depressive
What is being tested?
Smartphone-Assisted MB-CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteCanada
Study dates
19 Jan 2018to 30 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • < 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Smartphone-Assisted MB-CBT
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone-Assisted MB-CBTBehavioural

    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).

Study groups in NCT03406052
Study groupRoleWhat they receive
Smartphone-Assisted MB-CBTExperimentalOnline intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content
Receives: Behavioral: Smartphone-Assisted MB-CBT
ControlNo interventionStandard psychiatric care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beck Depression Inventory II

    Change from baseline self report of symptoms of depression

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (5)

  1. Beck Anxiety Scale

    Change from baseline self report of anxiety symptoms

    Measured: Baseline, 3 months, 6 months

  2. Quick Inventory of Depressive Symptomatology

    Change from baseline self report of symptoms of depression

    Measured: Baseline, 3 months, 6 months

  3. Hamilton Depression Rating Scale (HRDS-24)

    Change from baseline interview and interviewer rating of symptoms of depression

    Measured: Baseline, 3 months, 6 months

  4. Five-Facet Mindfulness Questionnaire

    Change from baseline self report of mindfulness experience

    Measured: Baseline, 3 months, 6 months

  5. Brief Pain Inventory

    Change from baseline self report of pain intensity

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start19 Jan 2018
  3. Primary completion31 Mar 2019
  4. Study completion30 May 2019 (estimated)

Why it stopped: New funding required

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406052
Sponsor's protocol ID
Yorku
Other IDs
2016-115, 2017-154
Status last verified
Apr 2019
First submitted
4 Dec 2017
Last updated
23 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23022436

  • 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.

    PubMed 22037137

  • 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.

    PubMed 26441467

  • 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.

    PubMed 26116778

  • 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.

    PubMed 22122217

  • 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.

    PubMed 27769879

  • 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.

    PubMed 26199275

  • 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.

    PubMed 20946914

  • 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.

    PubMed 19922906

  • 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.

    PubMed 38820586

  • 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.

    PubMed 38064262

  • 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.

    PubMed 33688840

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone-Assisted MB-CBT in people with Disorder, Major Depressive, run by York University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory II (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03406052, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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