Impact Study of Workplace Mental Health Education on Early Intervention for Healthcare Workers With Mental Health Issues

March 15, 2016 updated by: McMaster University

Beyond Silence: Comparing the Impact of Contact-based Education With Mental Health Literacy Training on Early Intervention for Healthcare Workers With Mental Health Issues

The purpose of this study is to compare the impact of a new workplace-based mental health peer education program with standardized mental health literacy training on early intervention and support for healthcare employees with mental health issues. Participants are healthcare workers who volunteer to participate in one of the two twelve-hour group education programs. It is hypothesized that the customized "Beyond Silence" peer education program led by trained staff members with personal experience of mental ill-health will be more effective in reducing the stigma associated with help-seeking and help-outreach regarding mental ill-health in the workplace. The comparison group is a standardized mental health literacy training program that has been widely implemented in both Canada and around the world. Change in help-seeking/help-outreach behavior, mental health knowledge and beliefs of participants will be assessed at three-month intervals; before, after and three months following the educational intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The target sample of 200 employee participants will be recruited from two healthcare organizations. The Beyond Silence program is based on principles of contact-based education, and will include six 1.5-2 hour in-person sessions conducted every other week, interspersed with five online resource sessions. The Mental Health First Aid training is a standardized, 12-hour evidence-based mental health literacy training program that has been implemented in a range of national and international settings. This program is typically offered over two full days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences
      • Hamilton, Ontario, Canada
        • St. Joseph's Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Employee (full-time, part-time or contract) in the participating healthcare organization
  • Willing and able to participate in 12 hours of training outside of paid work hours
  • Able to understand and speak English

Exclusion Criteria:

  • Prior training in either of the two educational approaches

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Contact-based mental health education
The "Beyond Silence' program is 12 hours in length: six 1.5-2 hour in-person group sessions every other week, plus five online sessions between each of the in-person sessions.
Behavioral: Beyond Silence
Pilot data from initial phases of the project and best practice principles in contact based education and adult learning theory informed curriculum design. The six in-person sessions use workplace-based vignettes to prompt reflection and discussion, build mental health literacy, reduce stigma, and promote communication and coping skill development. The virtual sessions use a secure online discussion board for participants to explore relevant online resources. All sessions will be co-led by trained peer educators; employees who have personally experienced mental ill health and recovery and are viewed as credible leaders within the organization. They will be recruited and trained to effectively teach the content, share personal experiences, and facilitate discussion.
Other Names:
  • Contact-based mental health education
Active Comparator: Mental health literacy training
"Mental Health First Aid" training consists of twelve hours of standardized, module-based mental health literacy training offered in a group format. It will be offered as 2 full-day training sessions (or four half-day sessions).
Behavioral: Mental Health First Aid (MHFA)
MHFA is a standardized, twelve-hour educational program designed to teach participants how to recognize the early warning signs of mental illness, how to provide initial help to someone in a mental health crisis, and how to support people who are developing mental health problems. It is an evidence-based approach that originated in Australia, but is being implemented across Canada, under the leadership of the Mental Health Commission of Canada. Leadership of the MHFA will be provided by an employee in each organization who has been trained through the 5-day national MHFA instructor training program. The instructor does not share any personal experiences regarding mental health issues.
Other Names:
  • Mental health literacy training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in help-seeking behavior
Time Frame: Baseline, post-intervention, 3 month follow-up
Participants will be asked to report whether they accessed any services from a list of 10 health, workplace and community service options. Questions regarding service utilization are adapted from the 2012/2012 Canadian Community Health survey, in order to provide a population reference, plus several work-related services (eg. EAP, union) are added as an option. Participants may endorse more than one of the behaviors, and a summative score of the number of behaviors will be used to measure change in help-seeking.
Baseline, post-intervention, 3 month follow-up
Change from baseline in help-outreach behavior
Time Frame: Baseline, post-intervention, 3 month follow-up
Self-report of personal contact with a co-worker about mental health problems (yes/no), and any contact over the past 6 months (yes/no). If contact did occur, participants will be asked whether they provided help to the co-worker, and if so, to identify the type of help from a list of 10 possible options. The list of "outreach" behaviors was based on Mental Health First Aid program evaluation (e.g. 'spent time listening to problem', 'recommend professional help'), with an adaptation to include a several work-specific options (e.g., 'recommend EAP', 'offered assistance with job duties'). Participants are invited to check all behaviors that apply (with an open-ended option), and scoring is based on one point per action, with a summative score used to track change. In addition to the behavior list, participants will be asked to rate their confidence in providing help on a 7 point Likert scale.
Baseline, post-intervention, 3 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in degree of stigma towards co-workers with a mental illness
Time Frame: Baseline, post-intervention, 3 month follow-up
The Mental Health Commission of Canada Opening Minds Scale for Healthcare Providers will be used; a 20-item questionnaire designed to evaluate the attitudes of healthcare providers towards people with mental illness. The tool has good internal consistency (α=.82), and satisfactory test-retest reliability (ICC=.66), with limited impact of social desirability.
Baseline, post-intervention, 3 month follow-up
Change from baseline in mental health literacy
Time Frame: Baseline, post-intervention, 3 month follow-up
Four vignettes of employees with workplace mental health issues will be used to assess awareness of issues and when/how to respond to these issues in the workplace. The vignettes are adapted for a healthcare workplace based on a review of vignettes reported in the literature, as well as analysis of key issues reported in the pilot phase of the study. Vignettes will incorporate differences in gender, nature and severity of illness, and a 7 point Likert scale from novice to expert will be used to track key dimensions of literacy, including perceived knowledge about the condition, what to say/do and what resources to access.
Baseline, post-intervention, 3 month follow-up
Change from baseline in attitudes toward professional help-seeking for mental health issues
Time Frame: Baseline, post-intervention, 3 month follow-up
The Attitudes Toward Seeking Professional Psychological Help Scale-short form (ATSPPHS), a 10 question survey using a four point Likert-type scale response will be used to track beliefs and intent to seek professional help. It is a widely used scale with good internal consistency (α=.78), and criterion validity supported by links between scale scores and mental healthcare use.
Baseline, post-intervention, 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hamilton Health Sciences Corporation
Ontario Mental Health Foundation
St. Joseph's Health Care London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandra E Moll, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MBSi14-385

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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