An Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth Diagnosed With Major Depressive Disorders: Protocol for a Randomized Controlled Trial.

cognitive behavioral therapy depression fitbit intervention study mhealth mobile phone telemedicine

Journal

JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504

Informations de publication

Date de publication:
29 Jul 2019
Historique:
received: 26 07 2018
accepted: 21 12 2018
revised: 12 12 2018
entrez: 31 7 2019
pubmed: 31 7 2019
medline: 31 7 2019
Statut: epublish

Résumé

About 70% of all mental health disorders appear before the age of 25 years. When untreated, these disorders can become long-standing and impair multiple life domains. When compared with all Canadian youth (of different ages), individuals aged between 15 and 25 years are significantly more likely to experience mental health disorders, substance dependencies, and risks for suicidal ideation and death by suicide. Progress in the treatment of youth, capitalizing on their online responsivity, can strategically address depressive disorders. We will conduct a randomized controlled trial to compare online mindfulness-oriented cognitive behavioral therapy (CBT-M) combined with standard psychiatric care versus psychiatric care alone in youth diagnosed with major depressive disorder. We will enroll 168 subjects in the age range of 18 to 30 years; 50% of subjects will be from First Nations (FN) backgrounds, whereas the other 50% will be from all other ethnic backgrounds. There will be equal stratification into 2 intervention groups (INT The inclusion criteria are: (1) age 18 to 30 years, FN background or other ethnicity; (2) Beck Depression Inventory (BDI)-II of at least mild severity (BDI-II score ≥14) and no upper limit; (3) Mini-International Neuropsychiatric Interview (MINI)-confirmed psychiatric diagnosis of major depressive disorder; and (4) fluent in English. All patients are diagnosed by a Centre for Addiction and Mental Health psychiatrist, with diagnoses confirmed using the MINI interview. The exclusion criteria are: (1) individuals receiving weekly structured psychotherapy; (2) individuals who meet the Diagnostic and Statistical Manual of Mental Disorders criteria for severe alcohol/substance use disorder in the past 3 months, or who demonstrate clinically significant suicidal ideation defined as imminent intent, or who have attempted suicide in the past 6 months; and (3) individuals with comorbid diagnoses of borderline personality, schizophrenia, bipolar disorder, and/or obsessive compulsive disorder. All subjects are provided standard psychiatric care defined as 1 monthly session that focuses on appropriate medication, with session durations of 15 to 30 min. Experimental subjects receive an additional intervention consisting of the CBT-M online software program (in collaboration with Nex J Health, Inc). Exposure to and interaction with the online workbooks are combined with navigation-coaching delivered by phone and secure text message interactions. The outcomes selected, combined with measurement blinding, are key features in assessing whether significant benefits regarding depression and anxiety symptoms occur. If results confirm the hypothesis that youth can be effectively treated with online CBT-M, effective services may be widely delivered with less geographic restriction. PRR1-10.2196/11591.

Sections du résumé

BACKGROUND BACKGROUND
About 70% of all mental health disorders appear before the age of 25 years. When untreated, these disorders can become long-standing and impair multiple life domains. When compared with all Canadian youth (of different ages), individuals aged between 15 and 25 years are significantly more likely to experience mental health disorders, substance dependencies, and risks for suicidal ideation and death by suicide. Progress in the treatment of youth, capitalizing on their online responsivity, can strategically address depressive disorders.
OBJECTIVE OBJECTIVE
We will conduct a randomized controlled trial to compare online mindfulness-oriented cognitive behavioral therapy (CBT-M) combined with standard psychiatric care versus psychiatric care alone in youth diagnosed with major depressive disorder. We will enroll 168 subjects in the age range of 18 to 30 years; 50% of subjects will be from First Nations (FN) backgrounds, whereas the other 50% will be from all other ethnic backgrounds. There will be equal stratification into 2 intervention groups (INT
METHODS METHODS
The inclusion criteria are: (1) age 18 to 30 years, FN background or other ethnicity; (2) Beck Depression Inventory (BDI)-II of at least mild severity (BDI-II score ≥14) and no upper limit; (3) Mini-International Neuropsychiatric Interview (MINI)-confirmed psychiatric diagnosis of major depressive disorder; and (4) fluent in English. All patients are diagnosed by a Centre for Addiction and Mental Health psychiatrist, with diagnoses confirmed using the MINI interview. The exclusion criteria are: (1) individuals receiving weekly structured psychotherapy; (2) individuals who meet the Diagnostic and Statistical Manual of Mental Disorders criteria for severe alcohol/substance use disorder in the past 3 months, or who demonstrate clinically significant suicidal ideation defined as imminent intent, or who have attempted suicide in the past 6 months; and (3) individuals with comorbid diagnoses of borderline personality, schizophrenia, bipolar disorder, and/or obsessive compulsive disorder. All subjects are provided standard psychiatric care defined as 1 monthly session that focuses on appropriate medication, with session durations of 15 to 30 min. Experimental subjects receive an additional intervention consisting of the CBT-M online software program (in collaboration with Nex J Health, Inc). Exposure to and interaction with the online workbooks are combined with navigation-coaching delivered by phone and secure text message interactions.
RESULTS RESULTS
The outcomes selected, combined with measurement blinding, are key features in assessing whether significant benefits regarding depression and anxiety symptoms occur.
CONCLUSIONS CONCLUSIONS
If results confirm the hypothesis that youth can be effectively treated with online CBT-M, effective services may be widely delivered with less geographic restriction.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) UNASSIGNED
PRR1-10.2196/11591.

Identifiants

pubmed: 31359869
pii: v8i7e11591
doi: 10.2196/11591
pmc: PMC6690226
doi:

Types de publication

Journal Article

Langues

eng

Pagination

e11591

Informations de copyright

©Paul Ritvo, Zafiris J Daskalakis, George Tomlinson, Arun Ravindran, Renee Linklater, Megan Kirk Chang, Yuliya Knyahnytska, Jonathan Lee, Nazanin Alavi, Shari Bai, Lillian Harber, Tania Jain, Joel Katz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.07.2019.

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Auteurs

Paul Ritvo (P)

School of Kinesiology and Health Science, York University, Toronto, ON, Canada.

Zafiris J Daskalakis (ZJ)

Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.

George Tomlinson (G)

THETA and Biostatistics Unit, University Health Network, Toronto, ON, Canada.

Arun Ravindran (A)

Campbell Family Mental Health Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.

Renee Linklater (R)

Aboriginal Engagement and Outreach, Centre for Addiction and Mental Health, Toronto, ON, Canada.

Megan Kirk Chang (M)

School of Kinesiology and Health Science, York University, Toronto, ON, Canada.

Yuliya Knyahnytska (Y)

Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.

Jonathan Lee (J)

Child and Youth Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.

Nazanin Alavi (N)

Department of Psychiatry, University of Toronto, Toronto, ON, Canada.

Shari Bai (S)

Centre for Addiction and Mental Health, Toronto, ON, Canada.

Lillian Harber (L)

Mood and Anxiety Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.

Tania Jain (T)

Mood and Anxiety Services, Centre for Addiction and Mental Health, Toronto, ON, Canada.

Joel Katz (J)

Department of Psychology, York University, Toronto, ON, Canada.

Classifications MeSH