NCT04311203

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

March 3, 2020

Last Update Submit

July 3, 2020

Conditions

Keywords

Mental health first aidHelp-seeking behavioursWorkplaceProcess evaluationEconomic evaluation

Outcome Measures

Primary Outcomes (1)

  • Change in Employees' help-seeking behaviour

    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.

    6, 12 and 24 months.

Secondary Outcomes (9)

  • Demographics

    Baseline

  • Change in Employees Help Seeking Intentions

    Baseline, 6, 12 and 24 months.

  • Change in Employees' Mental Health and Well-being

    Baseline, 6, 12 and 24 months.

  • Change in Mental Health First-Aiders' Mental Health Literacy

    Baseline, 1, 6, 12 and 24 months.

  • Change in Employees' Quality of Life

    Baseline, 6, 12 and 24 months.

  • +4 more secondary outcomes

Study Arms (2)

Mental Health First Aid Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

A brief consultation from MHFAE on the promotion of mental health and well-being in the workplace.

Interventions

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.

Mental Health First Aid Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London South Bank University

London, United Kingdom

RECRUITING

Related Publications (1)

  • Atanda O, Callaghan P, Carter T, Durcan G, O'Shea N, Brown SD, Reavey P, Vangeli E, White S, Wood KV. Evaluation of Mental Health First Aid from the Perspective Of Workplace End UseRs-EMPOWER: protocol of cluster randomised trial phase. Trials. 2020 Aug 14;21(1):715. doi: 10.1186/s13063-020-04636-0.

MeSH Terms

Conditions

Help-Seeking Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Patrick Callaghan, PhD

    London South Bank University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerry Wood, PhD

CONTACT

Patrick Callaghan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and researchers will not be blinded to treatment allocation due to the nature of the study.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 17, 2020

Study Start

January 20, 2020

Primary Completion

June 20, 2021

Study Completion

January 20, 2022

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations