Condition category
Mental and Behavioural Disorders
Date applied
21/10/2020
Date assigned
16/11/2020
Last edited
11/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Currently, student Health Care Professionals (SHCPs) face distinct and unique pressures on their mental health and are experiencing poorer mental health, such as heightened levels of anxiety and depression. Part of this is a result of the interactions that they are required to have with patients and families via remote means (e.g. by phone) due to social distancing and which is highly pressured and intense given the unforeseen impact of the COVID-19 pandemic. The researchers have undertaken many small research studies, which, when combined, have given them a new model to guide specialist practice and training, the Model of Emotions, Adaptation and Hope (MEAH). The MEAH allows the researchers to provide a single e-learning training session which includes: (a) mental health screening of SHCP by self-completing the MEAH questionnaire, (b) a brief mental health intervention involving a 20-minute e-based or telephone call around the screening and (c) teaching of a storytelling-based therapy (underpinned by the MEAH model to enhance interactions). They have named this e-learning training package the Screen, Intervene, and Train (SIT) approach to care. The aim of this study is to investigate the impact of a 2-hour MEAH e-learning training session on depression and anxiety of SHCPs.

Who can participate?
Students who are completing a UK health care course at a participating university

What does the study involve?
Students participate in one of three groups for a period of 2 hours. All active groups or interventions are delivered virtually. The SIT intervention will include a single screening interview taking 20 minutes with Dr A Soundy. Following this, the participant will be sent a pre-recorded e-based training session. The lecture takes 45 minutes. The indicative content considers examples of interactions, the science behind the MEAH, the use of screening and how to engage in a brief narrative-based intervention within practice. It has the same components as the pilot studies, although adapted into one training session. The final part of the training for SHCP will include an e-learning presentation. The presentation will provide an analysis of the screening calls. This will reveal the most common difficulties and stories expressed within screening and will summarise the difficulties that were challenging to adapt to, an illustration of how the MEAH is important for this understanding and the most common coping strategies identified (this was undertaken and achieved as part of the pilot research to consolidate learning). The principles are that sharing this information will provide direct access to others' experiences which has been associated with enhanced mental health outcomes. The benefit of this is SHCP can access effective coping strategies that promote mental health and psychological well-being outcomes. This entire process will take a maximum of 2 hours to complete at a pace and time that is convenient for the participant. The inactive waiting list control group will receive or be offered the SIT intervention at week 12. The active control group will receive an alternative e-intervention which includes a 45-minute pre-recorded lecture. Individuals in this group will receive or be offered the SIT intervention at week 12. The follow-up assessment for all groups will be at 3 months.

What are the possible benefits and risks of participating?
There may be mental health benefits for the student with improved communication skills and better psychological care for the patient.

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

When is the study starting and how long is it expected to run for?
September 2020 to September 2021

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr A Soundy
A.A.Soundy@bham.ac.uk

Trial website

https://www.meah.rocks

Contact information

Type

Scientific

Primary contact

Dr Andrew Soundy

ORCID ID

https://orcid.org/0000-0002-5118-5872

Contact details

School of Sport
Exercise and Rehabilitation Sciences
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4148385
A.A.Soundy@bham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Mental Health Screening, Intervening and Training (SIT) of student health care professionals; a multi-methods study

Acronym

SIT

Study hypothesis

Student health care professionals who are training using the model of emotions, adaptation and hope will obtain mental health and interactional benefits compared to motivational interviewing and a waiting list control condition.

Ethics approval

Approved 29/09/2019, Science, Technology, Engineering and Mathematics Ethical Review Committee (Research Support Group, C Block Dome, Aston Webb Building, University of Birmingham, Edgbaston, B15 2TT, UK; +44 (0)121 414 8825; s.l.cottam@bham.ac.uk), ref: ERN_18-1970D

Study design

Multi-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Other

Trial type

Other

Patient information sheet

https://www.meah.rocks/information-sheet-national-student-

Condition

Mental health of student health care professionals

Intervention

Group 1. Model of emotions, adaptation and hope
Group 2. Motivational interviewing
Group 3. Waiting list control

Intervention: The SIT intervention will include a single screening interview taking 20 minutes with Dr A Soundy. Following this, the participant will be sent a pre-recorded e-based training session. The lecture takes 45 minutes. The indicative content considers examples of interactions, the science behind the MEAH, the use of screening and how to engage in a brief narrative-based intervention within practice. It has the same components as the pilot studies, although adapted into one training session. The final part of the training for SHCP will include an e-learning presentation. The presentation will provide an analysis of the screening calls. This will reveal the most common difficulties and stories expressed within screening and will summarise the difficulties that were challenging to adapt to, an illustration of how the MEAH is important for this understanding and the most common coping strategies identified (this was undertaken and achieved as part of the pilot research to consolidate learning). The principles are that sharing this information will provide direct access to others' experiences which has been associated with enhanced mental health outcomes (Ooms et al., 2016; Soundy et al., 2019). The benefit of this is SHCP can access effective coping strategies that promote mental health and psychological well-being outcomes. This entire process will take a maximum of two hours to complete at a pace and time that is convenient for the participant.

Inactive control group 1: an inactive waiting list control group will be used. Individuals in this group will receive or be offered the SIT intervention at week 12.

Active control group 2: an alternative e-intervention will be used which includes a 45-minute pre-recorded lecture. Individuals in this group will receive or be offered the SIT intervention at week 12.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Depression and anxiety measured using The Hospital Anxiety and Depression Scale (HADS) pre, immediately post intervention, and at 12 weeks

Secondary outcome measures

Measured pre, immediately post intervention, and at 12 weeks:
1. Quality of life measured using the SF-12 quality of life questionnaire
2. Stigmatising attitudes and intentions of behaviour measured using the open minds scale for health care providers
3. Communication assessed using the Froehlich Communication Survey
4. Empathy measured using the interpersonal reactivity index
5. Hope measured using the Adult Hope Scale
6. Emotions, adaptation and hope measured using the MEAH version 3.3

Overall trial start date

01/09/2020

Overall trial end date

01/09/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Any student health care professional currently studying at one of the following Universities:
1. Southampton University
2. Birmingham City University
3. Oxford Brookes University
4. Coventry University
5. Nottingham University

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

280

Participant exclusion criteria

Participated in the pilot study

Recruitment start date

26/10/2020

Recruitment end date

07/06/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
School of Sport, Exercise and Rehabilitation Sciences
Brimingham
B15 2TT
United Kingdom

Trial participating centre

School of Health Sciences
University of Brighton Westlain House Falmer
Brighton
BN1 9PH
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

c/o Clarke Crawford
University of Birmingham Medical School
Birmingham
B15 2TT
United Kingdom
+44 (0)1214147678
C.J.Crawford@bham.ac.uk

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/index.aspx

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/03/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2020: Trial's existence confirmed by the Science, Technology, Engineering and Mathematics Ethical Review Committee.