Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03406052|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Disorder, Major Depressive||Behavioral: Smartphone-Assisted MB-CBT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, 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.|
|Primary Purpose:||Supportive Care|
|Official Title:||An Innovative Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders|
|Actual Study Start Date :||January 19, 2018|
|Estimated Primary Completion Date :||March 30, 2018|
|Estimated Study Completion Date :||March 30, 2018|
Experimental: Smartphone-Assisted MB-CBT
Online intervention accessed through smartphone or online accessed computer comprised of Mindfulness-Based Cognitive Behaviour content
Behavioral: Smartphone-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).
No Intervention: Control
Standard psychiatric care
- Beck Depression Inventory II [ Time Frame: Baseline, 3 months, 6 months ]Change from baseline self report of symptoms of depression
- Beck Anxiety Scale [ Time Frame: Baseline, 3 months, 6 months ]Change from baseline self report of anxiety symptoms
- Quick Inventory of Depressive Symptomatology [ Time Frame: Baseline, 3 months, 6 months ]Change from baseline self report of symptoms of depression
- Hamilton Depression Rating Scale (HRDS-24) [ Time Frame: Baseline, 3 months, 6 months ]Change from baseline interview and interviewer rating of symptoms of depression
- Five-Facet Mindfulness Questionnaire [ Time Frame: Baseline, 3 months, 6 months ]Change from baseline self report of mindfulness experience
- Brief Pain Inventory [ Time Frame: Baseline, 3 months, 6 months ]Change from baseline self report of pain intensity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406052
|Contact: Paul G Ritvo, PhD||416-736-2100 ext email@example.com|
|Contact: Zafiris J Daskalakis, MD,PhD||416-535-8501 ext 34319||Jeff.Daskalakis@camh.ca|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M6J 1H4|
|Contact: Jeff Daskalakis, MD,PhD 4165358501 ext 4319 firstname.lastname@example.org|
|Contact: Tania Jain, MSc 4165358501 ext 36347 email@example.com|
|Principal Investigator:||Paul G Ritvo, PhD||York University|