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Evaluation of Mental Health First Aid From the Perspective of Workplace End Users (EMPOWER)

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ClinicalTrials.gov Identifier: NCT04311203
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Mental Health First Aid England
Information provided by (Responsible Party):
London South Bank University

Brief Summary:
This trial will evaluate the effectiveness of Mental Health First Aid in the workplace. Half of the organisations will receive Mental Health First Aid training and half will receive treatment as usual (a brief consultation from Mental health First Aid England on mental health and well-being in the workplace).

Condition or disease Intervention/treatment Phase
Help-Seeking Behavior Behavioral: Mental Health First Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a multi-centred, two-arm clustered randomised controlled trial. Organisations will be randomly allocated to the control or intervention. The intervention is the standard MHFA intervention provided by Mental Health First Aid England (MHFAE). The control condition will be organisations having a brief consultation from MHFAE on promoting mental health and well-being in the workplace.
Masking: None (Open Label)
Masking Description: Participants and researchers will not be blinded to treatment allocation due to the nature of the study.
Primary Purpose: Other
Official Title: Evaluation of Mental Health First Aid From the Perspective of Workplace End Users - EMPOWER: Protocol of Trial Phase
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : June 20, 2021
Estimated Study Completion Date : January 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mental Health First Aid Intervention
Two-day MHFA training provided by MHFA England. Organisations will raise awareness of the presence of MHFA in the workplace, with delivery of MHFA by trained members to participants in the workplace.
Behavioral: Mental Health First Aid
The intervention has 3 parts:1.Two-day MHFA training provided by MHFA England. A manualised programme designed to provide individuals with: an in-depth understanding of mental health and the factors that can affect wellbeing, practical skills to spot triggers and signs of mental health issues, confidence to step in, reassure and support a person in distress, enhanced interpersonal skills such as non-judgemental listening, knowledge to help someone recover their health by guiding them to further support - whether that's self-help resources, through their employer, the NHS, or a mix. 2.Raising awareness of the presence of MHFA in the organisation. 3.The application of MHFA to participants in the workplace using the manualised five-stage approach, ALGEE: Approach the person, assess and assist with any crisis; Listen and communicate non-judgementally; Give support and information; Encourage the person to get appropriate professional help and Encourage them to seek other forms of support.

No Intervention: Control
A brief consultation from MHFAE on the promotion of mental health and well-being in the workplace.



Primary Outcome Measures :
  1. Change in Employees' help-seeking behaviour [ Time Frame: 6, 12 and 24 months. ]
    Measured by the Actual Help-Seeking Questionnaire [AHSQ] (Rickwood et al., 2005).The AHSQ measures help-seeking behaviour in the two-weeks preceding the assessment. Help-seeking behaviour is determined by listing the number of help sources and whether these have been sought in the time period and the issue for which they have been approached.


Secondary Outcome Measures :
  1. Demographics [ Time Frame: Baseline ]
    Age, gender, level of education, ethnicity, nature and frequency of any MHFA interventions directly experienced)

  2. Change in Employees Help Seeking Intentions [ Time Frame: Baseline, 6, 12 and 24 months. ]
    Employees Help seeking intentions measured by the General Help-Seeking Questionnaire [GHSQ] (Wilson et al, 2005). The GHSQ assesses future help-seeking intentions and recent and past help-seeking experiences. Intentions are measured by listing a number of potential help sources and asking employees to indicate how likely it is that they would seek help from that source for a specified problem on a 7-point scale ranging from (1) extremely unlikely to seek help to (7) extremely likely to seek help.

  3. Change in Employees' Mental Health and Well-being [ Time Frame: Baseline, 6, 12 and 24 months. ]
    Measured using the Warwick-Edinburgh Mental Health and Well-being Scale [WEMHWBS] (Tennant et al., 2007). The WEMWBS is a 14- item scale measuring mental well-being in general populations with 5 response categories: 1: none of the time to 5: all of the time in response to items such as I've been feeling optimistic about the future. Responses are summed to provide a single score ranging from 14-70. Higher scores indicate greater levels of Mental health and Wellbeing.

  4. Change in Mental Health First-Aiders' Mental Health Literacy [ Time Frame: Baseline, 1, 6, 12 and 24 months. ]
    Measured by the Mental Health Literacy Scale [MHLS], (O'Connor & Casey, 2015). The MHLS is a 35-item measure of mental health literacy - people's knowledge and beliefs of the recognition, management and prevention of mental disorders. Each item seeks a correct answer to each question with higher scores indicating higher levels of literacy.

  5. Change in Employees' Quality of Life [ Time Frame: Baseline, 6, 12 and 24 months. ]
    Measured using using the EQ-5D (Byford, 2013). The EQ-5D is a standardised measure of health-related quality of life (HRQoL) that provides a simple, generic measure of health for clinical and economic appraisal. The EQ-5D comprises five questions on mobility, self-care, pain, usual activities, and psychological status. For each question, there are 5 possible responses, ranging from best to worse. Possible scores for the EQ-5D-5 L range from 1 to - 0.594. On this scale it is considered equal to full health and 0 is equal to death. The scoring system allows for some health states to be considered 'worse than death'.

  6. Change in Employees' Self-Efficacy for Seeking Mental Health Care [ Time Frame: Baseline, 6, 12 and 24 months. ]
    Measured using the Employees' Self-Efficacy for Seeking Mental Health Care Scale [SE-SMHC] (Moore et al, 2015 adapted by Umubeyi et al, 2016).The SE-SMHC is a nine-item measure of recipients' confidence in seeking mental health care and comprises two sub-scales scales: one measuring confidence in knowing how to access mental health care and how to communicate with health care staff (SE-Knowledge), and successfully coping with the social and interpersonal consequences of seeking care (SE-Coping). The SE-SMHC is scored by asking employees to rank items from 1-10 and summed to determine low (1-3), medium (4-6) or high (7-10) confidence.

  7. Change in Employees Social well-being [ Time Frame: Baseline, 6, 12 and 24 months. ]
    Measured using the Social Well-being Scale [SWBS] (Keyes, 1998). The SWBS is a 15-item scale measuring five dimensions of social well-being, namely Social Coherence, Social Integration, Social Contribution, Social Actualisation and Social Acceptance. Participants respond to items such as "People do not care about other people's problems using a seven-point scale from strongly agree to strongly disagree which are summed for each dimension with a higher score representing greater social wellbeing.

  8. Change in Employees' use of standard mental health and other services [ Time Frame: Baseline, 6, 12 and 24 months. ]
    An adapted version of the Client Services Receipt Inventory [CSRI] (Beecham & Knapp, 2001). The CSRI gathers information on service utilisation, income, accommodation and other cost-related variables. It also captures resource use patterns and support costs to be estimated using an appropriate unit cost.

  9. Change in Employees' Quality of Life [ Time Frame: Baseline, 6, 12 and 24 months. ]
    Measured using the Short Form-12 Health Survey, [SF-12] (Ware et al, 1996). The SF-12 is 12 item standardised measure that assesses limitations in role functioning as a result of physical and mental health. A shorter form of the SF-36, the SF-12 has been used with a variety of clinical and non-clinical populations and captures eight domains of physical and mental health. Each item is scored from 1 (all of the time) to 5 (none of the time) in response to statements such as In the past four weeks, how much of the time has your physical or emotional problems interfered with your social activities? The key scores for the SF-12 are a physical health composite score (PCS-12) and a mental health score (MCS-12). Higher scores indicate higher levels of health.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: organisations expressing an interest (directly to MHFAE) in undertaking MHFA training, who have not undertaken this training previously; organisations who agree to participate and are able to provide data on sickness absenteeism, presenteeism and other productivity data

Exclusion Criteria: organisations who have already introduced MHFA across all sites and departments; those who decline to participate in adopting MHFA training; organisations and employees who participated in the pilot study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311203


Contacts
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Contact: Kerry Wood, PhD 020 7815 5467 woodk6@lsbu.ac.uk
Contact: Patrick Callaghan, PhD 020 7815 7603 callagp3@lsbu.ac.uk

Locations
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United Kingdom
London South Bank University Recruiting
London, United Kingdom
Contact: Wood Kerry, PhD       Woodk6@lsbu.ac.uk   
Sponsors and Collaborators
London South Bank University
Mental Health First Aid England
Investigators
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Principal Investigator: Patrick Callaghan, PhD London South Bank University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London South Bank University
ClinicalTrials.gov Identifier: NCT04311203    
Other Study ID Numbers: Evaluation of MHFA
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London South Bank University:
Mental health first aid
Help-seeking behaviours
Workplace
Process evaluation
Economic evaluation