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Mental Health ImpairmentNCT02158871

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

A study testing Beyond Silence and Mental Health First Aid (MHFA) in people with Mental Health Impairment, run by McMaster University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Mental Health Impairment
What is being tested?
Beyond Silence and Mental Health First Aid (MHFA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
2 sitesCanada
Study dates
May 2014to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Prior training in either of the two educational approaches

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Hamilton Health Sciences

    Hamilton, Ontario

  • St. Joseph's Healthcare

    Hamilton, Ontario

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Beyond Silence, Mental Health First Aid (MHFA)
Keywords
Education, Early intervention, Workplace, Stigma, Mental Health Literacy
Medical subject headings
Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beyond SilenceBehavioural

    Also called Contact-based mental health education

    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.

  • Mental Health First Aid (MHFA)Behavioural

    Also called Mental health literacy training

    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.

Study groups in NCT02158871
Study groupRoleWhat they receive
Contact-based mental health educationExperimentalThe "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.
Receives: Behavioral: Beyond Silence
Mental health literacy trainingActive comparator"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).
Receives: Behavioral: Mental Health First Aid (MHFA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in help-seeking behavior

    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.

    Measured: Baseline, post-intervention, 3 month follow-up

  2. Change from baseline in help-outreach behavior

    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.

    Measured: Baseline, post-intervention, 3 month follow-up

Secondary outcomes (3)

  1. Change from baseline in degree of stigma towards co-workers with a mental illness

    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.

    Measured: Baseline, post-intervention, 3 month follow-up

  2. Change from baseline in mental health literacy

    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.

    Measured: Baseline, post-intervention, 3 month follow-up

  3. Change from baseline in attitudes toward professional help-seeking for mental health issues

    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.

    Measured: Baseline, post-intervention, 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02158871
Sponsor's protocol ID
MBSi14-385
Status last verified
Mar 2016
First submitted
29 May 2014
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Richardson R, Dale HE, Robertson L, Meader N, Wellby G, McMillan D, Churchill R. Mental Health First Aid as a tool for improving mental health and well-being. Cochrane Database Syst Rev. 2023 Aug 22;8(8):CD013127. doi: 10.1002/14651858.CD013127.pub2.

    PubMed 37606172

  • Moll S, Patten SB, Stuart H, Kirsh B, MacDermid JC. Beyond silence: protocol for a randomized parallel-group trial comparing two approaches to workplace mental health education for healthcare employees. BMC Med Educ. 2015 Apr 16;15:78. doi: 10.1186/s12909-015-0363-9.

    PubMed 25880303

Questions about this trial

What is this clinical trial studying?

A study testing Beyond Silence and Mental Health First Aid (MHFA) in people with Mental Health Impairment, run by McMaster University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in help-seeking behavior (time frame: Baseline, post-intervention, 3 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02158871, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.

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