Administrative information
Title {1} | Evaluation of Mental Health First Aid from the Perspective of Workplace End Users – EMPOWER : Protocol of trial phase. |
Trial registration {2a and 2b}. | Clinicaltrials.gov. NCT04311203 |
Protocol version {3} | Version 18. |
Funding {4} | Mental Health First Aid England, 21 Prescot St, Whitechapel, London, E1 8BB. England. |
Author details {5a} | Patrick Callaghan, Professor of Mental Health Science, Division of Psychology, School of Applied Sciences, London South Bank University, 02078157603, callaghanp@lsbu.ac.uk Paula Reavey, Professor of Psychology & Mental Health, Division of Psychology, School of Applied Sciences, London South Bank University, 02078156177, reaveyp@lsbu.ac.uk Steven D. Brown, Professor of Health and Organisations, Nottingham Business School, Nottingham Trent University, steven.brown@ntu.ac.uk Kerry V. Wood, Senior Research Fellow, Division of Psychology, School of Applied Sciences, London South Bank University, 02078155467, woodk6@lsbu.ac.uk. Dr Graham Durcan, Associate Director, Centre for Mental Health, Technopark, 90 London Road, SE1 6LN, 07957595593, Graham.Durcan@centreformentalhealth.org.uk Nick O’Shea – Chief Economist. Centre for Mental Health, Technopark, 90 London Road SE1 6LN, 07759 155177, nick.oshea@centreformentalhealth.org.uk Tim Carter, Assistant Professor in Mental Health, Room D25, Institute of Mental Health, School of Health Sciences , University of Nottingham, Triumph Road, Nottingham NG7 2TU, 0115 74 84318, timothy.carter@nottingham.ac.uk Eleni Vangeli, Senior Lecturer, Division of Psychology, School of Applied Sciences, London South Bank University, 02078155806, vangelie@lsbu.ac.uk. Opeyemi Atanda, PhD candidate, Division of Psychology, School of Applied Sciences, London South Bank University, atandao2@lsbu.ac.uk. Dr Sarah White, Statistician, Population Health Research Institute, St George’s University of London, London, UK. swhite@sgul.ac.uk |
Name and contact information for the trial sponsor {5b} | London South Bank University, 103 Borough Road, London, SE1 0AA. |
Role of sponsor {5c} | The design, conduct, data collection, analyses and interpretation of the trial are conducted by the researchers. Based on the findings, papers for publication will be prepared by the research team who will have ultimate authority over these activities. MHFAE CIC will assist with access to organisations prior to their recruitment into the study. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
Measure | Timing of measures | ||||
---|---|---|---|---|---|
Baseline | Post-intervention (up to 3 months) | 6 months | 12 months | 24 months | |
Demographics (age, gender, level of education, ethnicity, nature and frequency of and MHFA interventions directly experienced, etc.) | X | ||||
Employees help-seeking intentions (General Help-Seeking Questionnaire) [12] | X | X | X | X | X |
Employees’ mental health and wellbeing (Warwick-Edinburgh Mental health and Well-being Scale) [13] | X | X | X | X | X |
Mental health first aiders’ mental health literacy (Mental Health Literacy Scale) [14]a | X | X | X | X | X |
Mental health first aiders’ skills (ALGEE scoring system) [15]a | X | X | X | X | X |
Employees’ quality of life (EQ-5D-5L and Short Form-12 Health Survey SF-12) [16] | X | X | X | X | X |
X | X | X | X | X | |
Employees’ social well-being (Social Well-being Scale) [19] | X | X | X | X | X |
Employees’ use of standard mental health and other services (adapted version of the Client Services receipt Inventory) [20] | X | X | X | X | X |
Assessment of cost-effectiveness
-
Personal (employees’ quality of life)
-
State/government (use of health and social services)
-
Employers (staff productivity)