NCT02777112

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,133

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

May 11, 2016

Last Update Submit

May 15, 2019

Conditions

Keywords

high-riskearly preventionproductivityreturn on investmentworkplacee-mental health programjob coach

Outcome Measures

Primary Outcomes (1)

  • Risk proportion of major depressive episode (MDE) over 12 months

    MDE occurred over the 12-month follow-up period will be measured by the Composite International Diagnostic Interview

    12-month follow-up assessment

Secondary Outcomes (5)

  • Change in depression score

    6- and 12-month follow-up assessment

  • Change in presenteeism

    baseline, 6- and 12-month follow-up assessment

  • Change in absenteeism

    baseline, 6- and 12-month follow-up assessment

  • Return on investment

    baseline, 6- and 12-month follow-up assessment

  • Change in anxiety score

    baseline, 6- and 12-month follow-up assessment

Other Outcomes (2)

  • Change in sleep disturbance

    baseline, 6- and 12-month follow-up assessment

  • Change in anger

    baseline, 6- and 12-month follow-up assessment

Study Arms (3)

Control

PLACEBO COMPARATOR

This group will receive generic information about depression and serve as control

Other: No intervention

e-mental health program

EXPERIMENTAL

This group will receive the developed e-mental health program

Other: e-mental health program

e-mental health program and job coaching

EXPERIMENTAL

This group will receive the developed e-mental health program plus interactive job coaching through telephone.

Other: e-mental health program and job coaching

Interventions

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.

e-mental health program

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.

e-mental health program and job coaching

Receiving generic information about men's depression from the Movember Foundation website: https://ca.movember.com/programs/mental-health

Also known as: control group
Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mathison Centre for Mental Health Research and Education

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (1)

  • Wang J, Patten SB, Lam RW, Attridge M, Ho K, Schmitz N, Marchand A, Lashewicz BM. The Effects of an E-Mental Health Program and Job Coaching on the Risk of Major Depression and Productivity in Canadian Male Workers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Nov 15;5(4):e218. doi: 10.2196/resprot.6350.

MeSH Terms

Conditions

DepressionMultiple Endocrine Neoplasia Type 1

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • JianLi Wang

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 19, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

May 17, 2019

Record last verified: 2019-05

Locations