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

Not Applicable
Suspended
Conditions
Disorder, Major Depressive
Interventions
Behavioral: Smartphone-Assisted MB-CBT
Registration Number
NCT03406052
Lead Sponsor
York University
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.

Recruitment & Eligibility

Status
SUSPENDED
Sex
All
Target Recruitment
168
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Smartphone-Assisted MB-CBTSmartphone-Assisted MB-CBTOnline intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content
Primary Outcome Measures
NameTimeMethod
Beck Depression Inventory IIBaseline, 3 months, 6 months

Change from baseline self report of symptoms of depression

Secondary Outcome Measures
NameTimeMethod
Beck Anxiety ScaleBaseline, 3 months, 6 months

Change from baseline self report of anxiety symptoms

Five-Facet Mindfulness QuestionnaireBaseline, 3 months, 6 months

Change from baseline self report of mindfulness experience

Hamilton Depression Rating Scale (HRDS-24)Baseline, 3 months, 6 months

Change from baseline interview and interviewer rating of symptoms of depression

Brief Pain InventoryBaseline, 3 months, 6 months

Change from baseline self report of pain intensity

Quick Inventory of Depressive SymptomatologyBaseline, 3 months, 6 months

Change from baseline self report of symptoms of depression

Trial Locations

Locations (1)

Centre for Addiction and Mental Health

🇨🇦

Toronto, Ontario, Canada

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