- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02158871
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
216
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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:
|
|
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).
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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.
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
May 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
May 29, 2014
First Submitted That Met QC Criteria
June 6, 2014
First Posted (Estimate)
June 9, 2014
Study Record Updates
Last Update Posted (Estimate)
March 17, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID 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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