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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Innovative Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders

Conditions
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Disorder, Major Depressive

Intervention / Treatment
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* Behavioral: Smartphone-Assisted MB-CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone-Assisted MB-CBT<br>Online intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content | Behavioral: Smartphone-Assisted MB-CBT<br>* 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).<br>|
| No Intervention: Control<br>Standard psychiatric care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory II | Change from baseline self report of symptoms of depression | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Scale | Change from baseline self report of anxiety symptoms | Baseline, 3 months, 6 months | 
| Quick Inventory of Depressive Symptomatology | Change from baseline self report of symptoms of depression | Baseline, 3 months, 6 months | 
| Hamilton Depression Rating Scale (HRDS-24) | Change from baseline interview and interviewer rating of symptoms of depression | Baseline, 3 months, 6 months | 
| Five-Facet Mindfulness Questionnaire | Change from baseline self report of mindfulness experience | Baseline, 3 months, 6 months | 
| Brief Pain Inventory | Change from baseline self report of pain intensity | Baseline, 3 months, 6 months |