- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02334020
Investigating the Impact of the Mental Health First-Aid Training Course in Danish Employees
Effectiveness of Mental Health First-Aid Training in Denmark. A Randomized Controlled Trial With a Six-Month Follow-Up Supplemented With a Qualitative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Studies show a high and growing prevalence of mental disorders in the population worldwide. 25 % of the general population in Europe will during their lifetime experience symptoms related to a mental disorder. The Mental Health First Aid concept (MHFA) was founded in 2000 in Australia by Kitchener and Jorm, in order to provide the population with mental health first aid skills.
Objective:
The aim of the concept is, through an educational intervention (course), to increase confidence in how to help people suffering from mental health problems. Further, secondary aims are to increase the mental health literacy of the public by increasing knowledge, reduce stigma and initiate more supportive actions leading towards professional help. An investigation of the effect of MHFA offered a Danish population is needed.
Design and Methods:
The design is a randomized controlled superiority trial, in which 500 participants will be allocated to either the intervention group or the control group. The control group will attend the course six months later, hence waiting list design. From fall 2013 to spring 2014 participants will be educated in Mental Health First-aid following a manualized, two days MHFA course. All the participants will answer a questionnaire at base-line and at 6 months follow-up. The questionnaire is a back-translation of the questionnaire used in Australian trials. The trial will be complemented by a qualitative study, in which focus groups will be carried out.
Outcome:
The primary outcome measure is increased confidence in help-giving behavior among the participants. Secondary outcome will be increased knowledge of and improved positive attitudes towards people suffering from a mental health problem.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2400
- Mental Health Center Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
people, who in their line of work are in contact with many different individuals
Exclusion Criteria:
none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training course
12 hour training course in Mental Health First-aid
|
2 days training course providing information on severe mental illness, in order to make people able to support in situations of crisis
|
|
Other: Waiting list
Waiting list design, hence delayed offering of Mental Health First-aid
|
2 days training course providing information on severe mental illness, in order to make people able to support in situations of crisis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increased confidence in help-giving behaviour as measured by comparing the intervention group after having attended the training course with the control group. (questionnaire)
Time Frame: 6 months
|
Continuous outcome measures will be analyzed using generalized linear models and dichotomous outcome measures will be analyzed using binary logistic regression.
Data will be analysed using IBM SPSS version 22.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Merete Nordentoft, Prof. Dr.med, Mental Health Centre, in the capital region of Denmark
Publications and helpful links
General Publications
- Jensen KB, Morthorst BR, Vendsborg PB, Hjorthoj C, Nordentoft M. Effectiveness of Mental Health First Aid training in Denmark: a randomized trial in waitlist design. Soc Psychiatry Psychiatr Epidemiol. 2016 Apr;51(4):597-606. doi: 10.1007/s00127-016-1176-9. Epub 2016 Feb 2.
- Jensen KB, Morthorst BR, Vendsborg PB, Hjorthoj CR, Nordentoft M. The effect of the mental health first-aid training course offered employees in Denmark: study protocol for a randomized waitlist-controlled superiority trial mixed with a qualitative study. BMC Psychiatry. 2015 Apr 14;15:80. doi: 10.1186/s12888-015-0466-1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MHFA Evaluation
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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