Disorder, Major Depressive
Conditions
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.
Interventions
BEHAVIORALSmartphone-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).
Sponsors
Centre for Addiction and Mental Health
York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Psychiatrists providing psychiatric care will be blinded to the group allocation of subjects under their treatment. One outcome assessor (who will conduct the 24-item Hamilton Rating Scale for Depression (HRSD-24) will be blinded. Investigators will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory II | Baseline, 3 months, 6 months | Change from baseline self report of symptoms of depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Scale | Baseline, 3 months, 6 months | Change from baseline self report of anxiety symptoms |
| Quick Inventory of Depressive Symptomatology | Baseline, 3 months, 6 months | Change from baseline self report of symptoms of depression |
| Hamilton Depression Rating Scale (HRDS-24) | Baseline, 3 months, 6 months | Change from baseline interview and interviewer rating of symptoms of depression |
| Five-Facet Mindfulness Questionnaire | Baseline, 3 months, 6 months | Change from baseline self report of mindfulness experience |
| Brief Pain Inventory | Baseline, 3 months, 6 months | Change from baseline self report of pain intensity |
Countries
Canada
Outcome results
None listed