NCT05154019

Brief Summary

This feasibility pilot cluster RCT aims to pilot and feasibility test an online training toolkit (Managing Minds at Work) for line managers to develop their knowledge and confidence in preventing work-related stress and promoting mental health at work. The setting is work organisations of different types and sectors across the Midlands region of the United Kingdom. Participants must have direct managerial or supervisor responsibilities for 3 or more staff members. The intervention consists of five modules of online learning: Looking after your own Mental Health; Designing and managing work to promote mental well-being; Management competencies to prevent work-related stress; Developing a psychologically safe work environment; Having conversations about mental health at work. Each module includes some descriptive content, interactive elements and opportunities for reflections, and take between 20-30 minutes to complete. Participating organisations will be allocated to either the intervention or control arm. A waiting list control will be used, with line managers in the control organisations starting the intervention 3-months after baseline. Data will be collected through online surveys with the intervention group at baseline, immediately post-intervention (around 6 weeks post baseline), 3-months follow-up and 6-months follow-up. Control group will complete the online surveys at baseline and 3-months (as they start the intervention) and immediately after completing the intervention. As a feasibility pilot study, analysis will be focused on acceptability of the intervention, feasibility of recruitment, retention and data collection, and estimating parameters for a larger trial. The primary outcome measure is line managers' confidence to create a mentally healthy workplace. The secondary outcomes line manger mental health knowledge, line manager workplace mental health literacy, line manager self-rating of behaviour. In addition, the direct reports of line managers will be invited to participate to assess the feasibility of collecting the outcome data related to: employee well-being, employee rating of line manager behaviour, employee sickness absence, employee productivity. A process evaluation will be conducted to assess intervention acceptability, usability, implementation and effectiveness. Qualitative data will be collected via module feedback forms and in-depth interviews with a sample of line managers from the intervention arm and stakeholders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

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

October 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

November 25, 2021

Last Update Submit

December 20, 2023

Conditions

Keywords

stressmental healthline manager

Outcome Measures

Primary Outcomes (3)

  • change in line managers confidence to create a mentally healthy workplace from baseline to 6 weeks

    Self-report scale assessing Confidence to Create Mentally Healthy Workplace (Gayed et al, 2109; Gayed et al, 2018). 6 items measured on 1 to 5 scale. Minimum value 5 (lowest confidence), maximum value 30 (highest confidence). Higher score means a better outcome.

    Baseline to 6 weeks follow-up

  • change in line managers confidence to create a mentally healthy workplace from baseline to 3 months

    Self-report scale assessing Confidence to Create Mentally Healthy Workplace (Gayed et al, 2109; Gayed et al, 2018). 6 items measured on 1 to 5 scale. Minimum value 5 (lowest confidence), maximum value 30 (highest confidence). Higher score means a better outcome

    Baseline to 3 months follow-up

  • change in line managers confidence to create a mentally healthy workplace from baseline to 6 months

    Self-report scale assessing Confidence to Create Mentally Healthy Workplace (Gayed et al, 2109; Gayed et al, 2018). 6 items measured on 1 to 5 scale. Minimum value 5 (lowest confidence), maximum value 30 (highest confidence). Higher score means a better outcome

    Baseline to 6 months follow-up

Secondary Outcomes (16)

  • change in line manger mental health knowledge from baseline to 6 weeks

    Baseline to 6 weeks follow-up

  • change in line manger mental health knowledge from baseline to 3 months

    Baseline to 3 months follow-up

  • change in line manger mental health knowledge from baseline to 6 months

    Baseline to 6 months follow-up

  • change in line manager workplace mental health literacy from baseline to 6 weeks

    Baseline to 6 weeks follow-up

  • change in line manager workplace mental health literacy from baseline to 3 months

    Baseline to 3 months follow-up

  • +11 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Line Managers from organisations in the intervention arm will complete a self-led online training course consisting of 5 modules, over a period of 5-6 weeks

Behavioral: Managing Minds at Work Online Training

Waitlist Control

NO INTERVENTION

Line Managers from organisations in the intervention arm will receive no training. They will be given access to the online intervention at the end of a 3-month period.

Interventions

The intervention will be an online, interactive training course which will include evidence-based material, guidance, and practical exercises. The training will cover the following topics, presented as a series of independent, stand-alone modules: Module one: Looking after your own mental health Module two: Designing and managing work to promote mental well-being Module three: Management Competencies that Prevent Work-related Stress Module four: Developing a Psychologically Safe Workplace Module five: Having conversations about mental health at work Each module will be designed to take between 20 and 30 minutes to complete. Participants will be permitted by their employer to complete the training within their work time. The training is self-led, so each participant can progress through each module at their own pace and at a time that suits them.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Employed
  • Direct managerial or supervision responsibility for three or more staff.
  • Has a work computer or mobile phone and email address with which to access the training and receive reminders
  • Ability to provide informed consent

You may not qualify if:

  • Not employed
  • Employed but due to retire or be made redundant in the next 6 months
  • Have undertaken work-based training on mental health at work within last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

Related Publications (2)

  • Hassard J, Blake H, Dulal-Arthur TM, Frost A, Bartle C, Yarker J, Munir F, Vaughan B, Daly G, Meyer C, Russell S, Thomson L. Web-Based Interactive Training for Managers (Managing Minds at Work) to Promote Mental Health at Work: Pilot Feasibility Cluster Randomized Controlled Trial. JMIR Ment Health. 2025 Sep 2;12:e76373. doi: 10.2196/76373.

  • Thomson L, Hassard J, Frost A, Bartle C, Yarker J, Munir F, Kneller R, Marwaha S, Daly G, Russell S, Meyer C, Vaughan B, Newman K, Blake H. Digital Training Program for Line Managers (Managing Minds at Work): Protocol for a Feasibility Pilot Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 24;12:e48758. doi: 10.2196/48758.

MeSH Terms

Conditions

Occupational StressIllness BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Louise Thomson, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Waiting list control. Control group receive the training 3 months after completing baseline
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 10, 2021

Study Start

October 20, 2021

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations