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The Effects of E-mental Health Program and Job Coaching on the Risk of Major Depression in Canadian Working Men

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Calgary
Sponsor:
Collaborator:
Movember Foundation
Information provided by (Responsible Party):
JianLi Wang, University of Calgary
ClinicalTrials.gov Identifier:
NCT02777112
First received: May 11, 2016
Last updated: October 17, 2016
Last verified: October 2016
  Purpose
There is a pressing need for innovation in prevention of major depression in male workers. Major depression (MDE) affects workers' health and productivity. In the United States, workers with depression cost an estimated US $44.01 billion per year in lost productivity. One of the severe consequences of having MDE is potential suicide and Canadian national data showed that 76% of all suicides in 2009 were male. In the workplace, risk factors for having MDE differ for men and women. For instance, job strain, family to work conflict and job insecurity seem to be more prominent MDE risk factors in men than in women. Compounding men's risk, men are less likely than women to seek help and to disclose depressive symptoms and often delay help seeking until symptoms become severe. Men are socialized to be emotionally stoic and exemplify traditional masculine characteristics such as independence, self-reliance and dominance. Men are concerned over the perceived negative judgments from family and friends if they access treatment for depression. These gender specific experiences along with a limited knowledge base about effective interventions call for innovative solutions tailored for men. The proposed study was to evaluate the effectiveness of an e-mental health program on reducing the risk of major depression in Canadian working men.

Condition Intervention
Depression
Men
Other: e-mental health program
Other: e-mental health program and job coaching
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of E-mental Health Program and Job Coaching on the Risk of Major Depression and Productivity in Canadian Male Workers

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Risk proportion of major depressive episode (MDE) over 12 months [ Time Frame: 12-month follow-up assessment ]
    MDE occurred over the 12-month follow-up period will be measured by the Composite International Diagnostic Interview


Secondary Outcome Measures:
  • Change in depression score [ Time Frame: 6- and 12-month follow-up assessment ]
    Depression score will be measured by the Patient Health Questionnaire (PHQ-9)

  • Change in presenteeism [ Time Frame: baseline, 6- and 12-month follow-up assessment ]
    To be measured by the World Health Organization (WHO)'s Health and Work Performance Questionnaire

  • Change in absenteeism [ Time Frame: baseline, 6- and 12-month follow-up assessment ]
    To be measured by the WHO's Health and Work Performance Questionnaire

  • Return on investment [ Time Frame: baseline, 6- and 12-month follow-up assessment ]
    To be measured by the WHO's Health and Work Performance Questionnaire

  • Change in anxiety score [ Time Frame: baseline, 6- and 12-month follow-up assessment ]
    Anxiety score will be measured by the Generalized Anxiety Disorder - 7 (GAD-7)


Other Outcome Measures:
  • Change in sleep disturbance [ Time Frame: baseline, 6- and 12-month follow-up assessment ]
    To be measured by the scale of the PROMIS

  • Change in anger [ Time Frame: baseline, 6- and 12-month follow-up assessment ]
    To be measured by the scale of the PROMIS


Estimated Enrollment: 1200
Study Start Date: September 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
This group will receive generic information about depression and serve as control
Other: No intervention
Receiving generic information about men's depression from the Movember Foundation website: https://ca.movember.com/programs/mental-health
Other Name: control group
Experimental: e-mental health program
This group will receive the developed e-mental health program
Other: e-mental health program
This program is delivered over the Internet, which includes modules of Information (about depression, workplace factors and alcohol use), Practical Tips (Cognitive Behavioral Therapy, Mindfulness relaxation, workplace strategies), Tools (for monitoring and predicting depression and occupational functioning), and Goal Setting and Tracking.
Experimental: e-mental health program and job coaching
This group will receive the developed e-mental health program plus interactive job coaching through telephone.
Other: e-mental health program and job coaching
This combines the e-mental health program and interactive job coaching delivered through telephone. The e-mental health program is delivered over the Internet, which includes modules of Information (about depression, workplace factors and alcohol use), Practical Tips (Cognitive Behavioral Therapy, Mindfulness relaxation, workplace strategies), Tools (for monitoring and predicting depression and occupational functioning), and Goal Setting and Tracking. The job coaching can be accessed by appointment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At the time of recruitment, working for pay
  • At the time of recruitment and baseline assessment, have a high risk of having major depressive episode (MDE) based on our prediction algorithm. For the proposed study, 6.51+% will be defined as high risk for men
  • May have MDE in the past 12 months, but in remission for at least 2 months prior to the study
  • Have no language barriers to English or French
  • Have access to the internet
  • Provide email and mailing address

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02777112

Contacts
Contact: JianLi Wang, PhD (403)210-8653 jlwang@ucalgary.ca
Contact: Erin Jones, BSc. (403) 210-6839 emjones@ucalgary.ca

Locations
Canada, Alberta
Mathison Centre for Mental Health Research and Education Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: JianLi Wang, PhD    403-210-8653    jlwang@ucalgary.ca   
Contact: Erin Jones    403-210-6839    emjones@ucalgary.ca   
Sub-Investigator: Scott B Patten, MD, PhD         
Sub-Investigator: Raymond W Lam, MD         
Sub-Investigator: Bonnie Lashewicz, PhD         
Sub-Investigator: David Hodgins, PhD         
Sub-Investigator: Kendall Ho, MD         
Sub-Investigator: Erin Michalak, PhD         
Sub-Investigator: Mark Attridge, PhD         
Sub-Investigator: Zul Merali, PhD         
Sub-Investigator: Norbert Schmitz, PhD         
Sub-Investigator: Alice Aiken, PhD         
Sub-Investigator: Alain Marchand, PhD         
Sponsors and Collaborators
University of Calgary
Movember Foundation
Investigators
Principal Investigator: JianLi Wang University of Calgary
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JianLi Wang, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02777112     History of Changes
Other Study ID Numbers: #UCAL_01
Study First Received: May 11, 2016
Last Updated: October 17, 2016
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Need to discuss with the ethics review board regarding the format of data sharing.

Keywords provided by University of Calgary:
high-risk
early prevention
productivity
return on investment
workplace
e-mental health program
job coach

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 24, 2017