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Investigating the Impact of the Mental Health First-Aid Training Course in Danish Employees

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ClinicalTrials.gov Identifier: NCT02334020
Recruitment Status : Unknown
Verified April 2015 by Merete Nordentoft, Mental Health Services in the Capital Region, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : January 8, 2015
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Merete Nordentoft, Mental Health Services in the Capital Region, Denmark

Tracking Information
First Submitted Date  ICMJE December 8, 2014
First Posted Date  ICMJE January 8, 2015
Last Update Posted Date April 28, 2015
Study Start Date  ICMJE September 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Impact of the Mental Health First-Aid Training Course in Danish Employees
Official Title  ICMJE Effectiveness of Mental Health First-Aid Training in Denmark. A Randomized Controlled Trial With a Six-Month Follow-Up Supplemented With a Qualitative Study
Brief Summary The purpose of the study is evaluate the effect of the Mental Health First-aid training course on a Danish population of employees.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Mental Health Impairment
Intervention  ICMJE Other: 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
Study Arms  ICMJE
  • Experimental: Training course
    12 hour training course in Mental Health First-aid
    Intervention: Other: Mental Health First-aid
  • Waiting list
    Waiting list design, hence delayed offering of Mental Health First-aid
    Intervention: Other: Mental Health First-aid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 7, 2015)
538
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

people, who in their line of work are in contact with many different individuals

Exclusion Criteria:

none

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02334020
Other Study ID Numbers  ICMJE MHFA Evaluation
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merete Nordentoft, Mental Health Services in the Capital Region, Denmark
Study Sponsor  ICMJE Mental Health Services in the Capital Region, Denmark
Collaborators  ICMJE TrygFonden, Denmark
Investigators  ICMJE
Principal Investigator: Merete Nordentoft, Prof. Dr.med Mental Health Centre, in the capital region of Denmark
PRS Account Mental Health Services in the Capital Region, Denmark
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP