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

Mental Health Impairment Clinical Trial

Official title:

Effectiveness of Mental Health First-Aid Training in Denmark. A Randomized Controlled Trial With a Six-Month Follow-Up Supplemented With a Qualitative Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02334020
• Other study ID #: MHFA Evaluation
• Status: Active, not recruiting
• Phase: N/A
• First received: December 8, 2014
• Last updated: April 25, 2015
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Mental Health Services in the Capital Region of Denmark
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is evaluate the effect of the Mental Health First-aid training course on a Danish population of employees.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 538
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Health Impairment

Intervention

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

Locations

Country	Name	City	State
Denmark	Mental Health Center Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased confidence in help-giving behaviour as measured by comparing the intervention group after having attended the training course with the control group. (questionnaire)	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	No