Mental Health ImpairmentNCT02334020
Investigating the Impact of the Mental Health First-Aid Training Course in Danish Employees
A study testing Mental Health First-aid in people with Mental Health Impairment, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Impairment
- What is being tested?
- Mental Health First-aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Jun 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- people, who in their line of work are in contact with many different individuals
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of the study is evaluate the effect of the Mental Health First-aid training course on a Danish population of employees.
Read the 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.
- Conditions
- Mental Health Impairment
- Being tested
- Mental Health First-aid
- Keywords
- Mental illness, training, support, Mental Health
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health First-aidOther
2 days training course providing information on severe mental illness, in order to make people able to support in situations of crisis
| Study group | Role | What they receive |
|---|---|---|
| Training course | Experimental | 12 hour training course in Mental Health First-aid Receives: Other: Mental Health First-aid |
| Waiting list | Other | Waiting list design, hence delayed offering of Mental Health First-aid Receives: Other: Mental Health First-aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Merete Nordentoft, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Merete Nordentoft, Prof. Dr.med, Principal investigator, Mental Health Centre, in the capital region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334020
- Sponsor's protocol ID
- MHFA Evaluation
- Status last verified
- Apr 2015
- First submitted
- 8 Dec 2014
- Last updated
- 28 Apr 2015
- 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 37606172Jensen 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.
PubMed 26837214Jensen 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.
PubMed 25884517
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02334020
- Acronym / sponsor ID
- MHFA Evaluation
- Conditions
- Mental Health Impairment
- Keywords
- Mental illness, training, support, Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2015 (estimated)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training course | Experimental | Other: Mental Health First-aid12 hour training course in Mental Health First-aid |
| Waiting list | Other | Other: Mental Health First-aidWaiting list design, hence delayed offering of Mental Health First-aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- people, who in their line of work are in contact with many different individuals
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Health First-aid2 days training course providing information on severe mental illness, in order to make people able to support in situations of crisis | Other | Training course, Waiting list |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Derived from this study: PubMed 37606172Richardson 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.
- Derived from this study: PubMed 26837214Jensen 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.
- Derived from this study: PubMed 25884517Jensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nordentoft, Prof. Dr.med principal investigator
Mental Health Centre, in the capital region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health First-aid in people with Mental Health Impairment, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
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?
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). 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 NCT02334020, which also lists 3 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 28 Apr 2015.