Condition category
Mental and Behavioural Disorders
Date applied
05/10/2016
Date assigned
05/10/2016
Last edited
05/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The mental health of medical students is important due to the stress associated with training to become a doctor and students’ roles as the healthcare professionals of the future. Medical students face many barriers to seeking out professional help and treatment for their mental health, including stigma (negative association) relating to having a mental health issue, and students often rely on support and advice from fellow students and friends. However, one of the biggest challenges students have in supporting friends is knowing what to do and how they can help a friend experiencing a mental health problem. Mental Health First Aid (MHFA) is a structured course designed to educate trainees about mental health (e.g. signs, symptoms and treatment options) and different mental health problems (e.g. depression, anxiety, psychosis), and to improve their abilities to help themselves and to help someone developing a mental health problem or crisis (e.g. feeling suicidal, self-harming). Central to the MHFA course is an action plan (‘ALGEE’) of five steps applied to someone in need: approach the person, and assess and assist with any crisis; listen non-judgementally to them; give them support and information; encourage the person to seek appropriate professional help; and encourage other support strategies. MHFA is usually delivered face-to-face in groups by an instructor, but has now been adapted to be delivered through an online eLearning course. The online course has been tested in Australia and has been adapted to be suitable and relevant for medical students. This study will test the MHFA eLearning course with British medical students, as it has only previously been tested in Australia. The aim of this study is to find out how completing the course affected students’ potential to support a friend with a mental health problem and their stigma towards mental illness.

Who can participate?
Students (aged 18 and over, any gender) in their first, second or third year of studying undergraduate or graduate-entry medicine at the University of Nottingham.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the MHFA eLearning course. Participants assigned to this group are given log-in details to independently access and complete the course over a six week period. The course consists of six modules completed in order (introduction to mental health and Mental Health First Aid; depression; anxiety problems; eating disorders; psychosis; and substance use problems), and its content is presented through text, images, audio, videos and interactive activities. It is supplemented with a physical MHFA manual and takes approximately 6-to-8 hours to complete. Participants also receive two emails during the six week period reminding them to complete the course. Those in the second group continue as normal for the duration of the study. At the start of the study and then again after six weeks, participants in both groups complete a range of questionnaires.

What are the possible benefits and risks of participating?
This is the first study testing out the MHFA eLearning course in the UK. It has previously been tested in Australia, and through testing it in the UK we could see whether British students liked or disliked the course, and whether they considered it appropriate. The course can lead to new knowledge about mental health and in particular how to support a friend in need. During their degree, medical students learn about mental health but this will be in the context of how to help patients. The doctor-patient relationship is different from the relationships students have with their friends, and so this course can help educate them in how to help a friend in need. At the end of the study, participants are asked whether they experienced any side effects or negative consequences as a result of participation and/or in completing the MHFA eLearning course. Another risk was that those assigned to the second group receive nothing. To make up for this, at the end of the study, these participants are given detailed information about available mental health resources and services. Including details about the mental health first aid guidelines freely and publically available on the MHFA Australia website.

Where is the study run from?
University of Nottingham (UK)

When is study starting and how long is it expected to run for?
May 2015 to December 2015

Who is funding the study?
NIHR MindTech Healthcare Technology Co-operative (UK)

Who is the main contact?
Dr Bethan Davies
bethan.davies@nottingham.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr E Bethan Davies

ORCID ID

Contact details

NIHR MindTech Healthcare Technology Co-operative
Institute of Mental Health
University of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom
+44 115 748 4238
bethan.davies@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

T14072015

Study information

Scientific title

A pilot randomised controlled study of the mental health first aid eLearning course with UK undergraduate medical students

Acronym

Study hypothesis

Students who receive the mental health first aid (MHFA) eLearning course would report higher mental health first aid intentions scores, fewer stigmatising attitudes and more confidence in supporting a peer, compared to a no-access control group.

Ethics approval

University of Nottingham (UoN) Medical and Health Sciences research ethics committee, 24/07/2015, ref: T14072015

Study design

Single-centre two-arm randomised controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

See additional files

Condition

Mental illness

Intervention

Participants are randomised to one of two groups through stratified random allocation (in blocks of four) to ensure equivalent numbers of male and female participants in each group. The researcher responsible for outcome assessment and data analysis (EB) was blinded to allocation, but it was not possible to blind participants.

Intervention group: Participants take part in a Mental Health First Aid (MHFA) eLearning course, which comprises of six modules completed consecutively. Each module focuses on a different mental disorder and associated crises, and are taught the disorder-specific MHFA action plan (i.e. approach the person, assess and assist with any crisis; listen non-judgementally; give support and information; encourage the person to seek appropriate professional help; and encourage other support strategies). Content is delivered through text, images, audio, videos and interactive activities, and completed at the user’s own pace over approximately 6-8 hours. Participants are given six weeks' access to the MHFA eLearning course, and receive a reminder email two and four weeks after randomisation.

Control group: Participants receive no intervention for the duration of the study.

Follow-up involves all participants being sent a second online questionnaire, which takes approximately 15-20 minutes to complete. This online questionnaire administered the same primary and secondary outcome measures as administered at baseline. Upon completing this questionnaire, all participants are directed to a debriefing webpage which informs them about the nature of the study, provided a list of mental health-related resources and services, and contact details of the research team. Participants, regardless of whether or not they complete the second online questionnaire, are also emailed a PDF version of this debriefing webpage.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Administered at baseline (pre-randomisation) and six-weeks post-randomisation/baseline:

1. Mental health first aid intentions: Participants are quasi-randomised (by month of birth) to read a text vignette describing a 21 year-old male university student (‘Mark’) experiencing symptoms of DSM-IV criteria for either depression or social anxiety/phobia. To assess mental health first aid intentions towards the vignette, participants answered an open-ended question: ‘Imagine Mark is someone you have known for a long time and care about. You want to help him. What would you do?". Participants’ qualitative responses are coded using a scoring scheme based on the MHFA action plan. Responses are coded for each ‘ALGEE’ component mentioned in the response (i.e. approach the person; assess and assist with any crisis; listen non-judgementally; give support and information; encourage appropriate professional help; and encourage other support). A score of ‘0’ indicates the component was not mentioned; ‘1’ is a helpful but superficial response; and ‘2’ is a good response with relevant specific detail. Scores from each component were summed to produce a total intentions score ranging from 0 to 12. Higher scores indicated better quality mental health first aid intentions.
2. Confidence to help a friend experiencing a mental health problem is assessed on a four-point Likert scale, ranging from “not confident at all” to “very confident”, or could select a “don’t know” option
3. Stigma towards mental illness is assessed using The personal stigma sub-scale of the Depression Stigma Scale (DSS), adapted for young people

Secondary outcome measures

1. Mental health: Participants’ current level of psychological distress is measured using the Depression Anxiety and Stress Scale, 21-item version (DASS-21) at baseline and six weeks
2. Recognition of a mental health problem: In response to viewing the vignette (see under 'Mental health first aid intentions' in Primary Outcome Measures), participants are asked to identify the main problem depicted in the vignette with an open-ended question: ‘What, if anything, would you say is Mark’s main problem?’ at baseline and six weeks
3. Actual mental health first aid actions taken: Participants self-reported how many times (“never”, “once”, “a few times”, “many times” they had spoken with a close other (e.g. friend, relative) about their mental health problem in the past six months (at baseline) and past six weeks (at follow-up). Participants are asked to indicate what actions they had taken through selecting from a list of nine actions presented on a checklist, which included a free-text box to enter additional actions.
4. Mental health knowledge is assessed using 20 true or false questions based on content within the MHFA eLearning course at baseline and six weeks
5. Feedback about participation and the MHFA eLearning course: Motivations for participating in the study are assessed using a multiple choice checklist of seven possible reasons for participation, alongside a free-text box for additional comments (intervention group participants also completed a series of rating scales and open-ended questions to gather their opinions about the MHFA eLearning course) at six weeks

Overall trial start date

01/05/2015

Overall trial end date

18/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Medical students (undergraduate or graduate entry medicine) studying at the University of Nottingham
2. Aged 18 years and over
3. In their first, second or third year of study
4. Have regular access to the internet and to a laptop/computer

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Students not studying medicine at the University of Nottingham
2. Aged 17 years or under
3. Medical students in their 4th, 5th or beyond 5th year of study
4. No access to internet and laptop/computer

Recruitment start date

01/10/2015

Recruitment end date

06/11/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Nottingham
Nottingham
NG7 2RD
United Kingdom

Sponsor information

Organisation

The University of Nottingham

Sponsor details

Division of Psychiatry & Applied Psychology
Institute of Mental Health
University of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom

Sponsor type

University/education

Website

https://www.nottingham.ac.uk/medicine/about/psychiatryandappliedpsychology/index.aspx

Funders

Funder type

Government

Funder name

NIHR MindTech Healthcare Technology Co-operative

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

All outcomes will be analysed and fully reported in a peer-reviewed publication between 12-18 months after the end of the trial.

IPD Sharing plan:
The dataset will not be made publically available because it is a small pilot trial which received no additional external funding. The data is held in password-protected file on the University of Nottingham file-server.

Intention to publish date

18/07/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes