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

Y

York University

Status

Suspended

Conditions

Disorder, Major Depressive

Treatments

Behavioral: Smartphone-Assisted MB-CBT

Study type

Interventional

Funder types

Other

Identifiers

NCT03406052
2016-115 (Other Identifier)
2017-154 (Other Grant/Funding Number)
Yorku

Details and patient eligibility

About

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.

Full 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.

Enrollment

168 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

168 participants in 2 patient groups

Smartphone-Assisted MB-CBT
Experimental group
Description:
Online intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content
Treatment:
Behavioral: Smartphone-Assisted MB-CBT
Control
No Intervention group
Description:
Standard psychiatric care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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