Clinical trial NCT05154019: Managing Minds at Work: A Feasibility Pilot Trial
Official title: Managing Minds at Work: A Feasibility Pilot Cluster Randomised Control Trial for Online Interactive Training for Managers (Managing Minds at Work)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Stress
Occupational Neurosis
Mental Health Wellness 1
Absence
Sickness Behavior
Keywords: stress
mental health
line manager
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Institute of Mental Health Nottingham
name: University of Warwick
name: Loughborough University
First posted: 2021-12-10
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waiting list control. Control group receive the training 3 months after completing baseline
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Study Aim

The overall aim of this project is to develop, pilot and feasibility test a new online training course (Managing Minds at Work) for line managers which provides guidance on preventing work-related stress and promoting mental health at work. This study will aim to assess the feasibility of a full cluster Randomised Controlled Trial (RCT) to assess the effectiveness of the training on improving line managers' outcomes (confidence, knowledge, behaviour) and employee outcomes (well-being, perceptions of line manager behaviours, sickness absence). In order to assess the feasibility and the potential effectiveness of the intervention, the study will test:

Study Objectives

The specific objectives are to test:

1. The potential for uptake within small, medium and large organisations by identifying and monitoring the:

   1. Willingness of employers to register interest in participating in the trial and allow line managers to take part in the trial.
   2. Recruitment and retention rates of line managers in the trial.
   3. Recruitment and retention of managers' direct reports.
2. The perceived suitability and effectiveness of the MMW intervention for line manager training by determining the:

   1. Acceptability, usability, and utility of the training among line managers and stakeholders within the participating organisations.
   2. Potential for improving line managers' confidence (primary outcome), knowledge and behaviours (secondary outcomes) to inform the planning of a larger trial.
   3. Potential for improving direct report outcomes (well-being, absence, self-reported productivity) by assessing changes to inform the planning of a larger trial.
3. The data collection methods for primary and secondary outcome measures to:

   1. Inform key parameters for a larger trial relating to sample size and clustering.
   2. Explore barriers and facilitators to the intervention implementation and effectiveness.

      Outcome Measures:
      * line managers confidence to create a mentally healthy workplace (primary)
      * line manger mental health knowledge
      * line manager workplace mental health literacy
      * line manager self-rating of behaviour
      * employee well-being
      * employee rating of line manager behaviour
      * employee sickness absence (organisational records)
      * employee productivity (self-reported)

      Study Design

      Cluster RCT Design This feasibility pilot study is a multi-site, two-armed cluster randomised controlled trial taking place in work organisations of different sizes and sectors across the Midlands area. The organisations are the units of randomisation (the clusters), with data collected from individual line managers (the participants) and the employees who work under their managers (their direct reports) within those organisations. If large, multi-site organisations are recruited to the study, the investigators will consider the option of using an internal control group within that organisation if there is a low risk of contamination between the intervention arm and control arm within that large organisation. The data collection schedule for the study is summarised in Table 2 and 3 below.

      Data Collection in Intervention Arm In the intervention arm, line managers will be invited to complete the online training course over a maximum period of 6 weeks. A repeated measures design will be adopted, whereby participants in the intervention arm will complete online questionnaires to collect data at baseline, on completion of the training (6 weeks), at 3 months follow-up and at 6-months follow-up. Line managers' direct reports will also be invited to complete online questionnaires at baseline, 3-months follow-up and 6-months follow-up. Where available, data will also be collected from organisational records on the sickness absence levels of employees managed by the participating line managers. Details of the measures in the online surveys are in the Outcome Measure section.

      Data Collection in Control Arm The study will employ a waitlist control, with line managers in the organisations within the control arm receiving the intervention after three months. Line managers in the control arm of the study will complete online questionnaires at baseline, just before the start of the training (3 months after baseline), immediately after completing the training (4.5 months after baseline). Line managers' direct reports will also be invited to complete online questionnaires at baseline and 3-months follow-up. Where available, data will also be collected from organisational records on the sickness absence levels of employees managed by the participating line managers. Details of the measures in the online surveys are in the Outcome Measure section

      Process Evaluation A qualitative process evaluation will run alongside the pilot trial to explore the experience of the intervention with line managers and other stakeholders within participating organisations, and assess the acceptability, usability and utility of the intervention and identify barriers and facilitators to implementation. Semi-structured interviews will be used to collect the data to inform the process evaluation. In addition, and module feedback forms will be completed by line managers after each of the modules in the training course to allow more specific feedback including any changes in their managerial practice that participants are planning to make as a result of completing the module.

      Randomization and Blinding Organisations (clusters) will be randomly assigned (1:1) to either the intervention or waiting list control group using an online random sequence generator (https://www.random.org/sequences/ ). This allocation will be stratified to ensure a spread of different size of organisations within the intervention and control arms. Where the organisation is sufficiently large to have distinct departments/divisions/units with minimal risk of contamination between them, the investigators will look to randomly assign two of these different departments/divisions/units to either intervention or the waiting list control using the same approach.

      The research team and participants will not be blinded to the outcome of randomisation due to practical reasons (i.e. sending reminder emails to participating managers).

      Selection and Withdrawal Of Participants Organisations The study setting will be any organisation with line managers and employees within the Midlands area. Participating organisations will be recruited through the communication channels (Twitter, Newsletters, Website). Organisations that register their interest will be receive a follow-up phone call from the lead researcher to provide further information about the study (Information Sheet for Organisation).

      Participants Managers within the participating organisations will be approached to participate in the study through a poster/flyer about the study, which will be shared with them by the gatekeeper within the organisation. Line managers who express interest in taking part will be given information about the study and asked to provide written consent prior to participating in the study (individual-level).

      Participating managers will be asked to share details of the study with their direct reports (people who they directly manage) to invite them to also participate in an online survey at baseline and 3 month follow-up.

      For the process evaluation interview study, participants will be invited to take part in interviews after the 6-month follow-up. Interviews will take place with:
      * Line managers in the intervention arm
      * Stakeholders (e.g. HR managers, Well-being co-ordinators etc) in both the intervention and control arms For line managers, on completing individual-level study consent all participants will have been asked to consent to being contacted by a qualitative researcher to take part in an interview. Those who have consented will be contacted and asked if they want to participate in a follow-up interview, and if so will be sent a PIS and consent form by email. Interviews will be conducted face-to-face, by video call or by telephone. Interviews will be arranged at a mutually convenient time and location.

      For stakeholders, the gatekeeper for each participating organisation (intervention and control arms) will be asked to email an invitation to participate in an interview to all relevant stakeholders within their organisation e.g. HR managers, well-being managers, learning and development managers, trade union representatives.

      Process Evaluation Interviews Semi-structured interviews will take place with line managers and direct reports from the intervention arm, and with stakeholders from both the intervention and control arm. These semi-structured interviews will be conducted with a random selection of participants following the completion of the training programme, to achieve a maximum variance sample based on size of organisation, sector, and participant demographics.

      Principles of data saturation will be used to guide the final sample size, but as a guideline the investigators would expect there to be interviews with approximately 20 line managers, 10 direct report, and 1 to 2 stakeholders per participating organisation. All of interviews and analysis will be conducted by member of the research team (CB, BV and KN). Interviews will be guided by the Interview Schedules and recorded using an encrypted digital recorder where consent is given. Digital audio files will be transferred to the transcription service Dict8 for transcription using secure FTP. Transcriptions will be anonymised. Audio files will be destroyed after transcripts have been checked. Anonymised transcriptions will be analysed and stored on the secure University of Nottingham server.

      Interviews with line managers

      The interview schedule will cover the following research questions and topics:
      * Acceptability, usability and utility of the intervention
      * Changes the line manager has introduced since undertaking the training
      * Barriers and facilitators to the intervention implementation and effectiveness
      * Suggested improvements to the intervention

      Interviews with stakeholders

      The interview schedule will cover the following research questions and topics:
      * Barriers and facilitators to taking part in the study
      * Acceptability of the wait-list control condition (control arm only)
      * Acceptability, usability and utility of the intervention
      * Barriers and facilitators to the intervention implementation and effectiveness

      Organisational Sickness Absence Records The investigators will collect information from the organisations regarding the sickness absence records of those the participating line managers directly manage. Pre-intervention data will cover the 6-months prior to the intervention. Post-intervention data will cover the 6-months post-intervention. All organisational absence records will be anonymised at source.

      Analyses

      Statistical Analysis and Sample size Statistical analysis will be produce summary statistics to assess the parameters for a full trial. Missing outcome data will be imputed using multiple imputation. SPSS will be used for statistical analysis.

      As this is a pilot trial, no emphasis will be put on the p values for any inferential statistical tests conducted. The pilot data will provide information on the parameters needed for a realistic sample size calculation (mean, standard deviation and treatment effects of the primary outcome for the two arms) for a future RCT. A minimum of 8 clusters (randomised into two groups of four) will be sought in order to inform a future trial.

      Process evaluation As part of the process evaluation additional qualitative data collection regarding the acceptability, usability, implementation, and effectiveness of the intervention will be collected through interviews with line managers, direct reports and stakeholders. The data collected analysed using thematic analysis within a framework approach.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: change in line managers confidence to create a mentally healthy workplace from baseline to 6 weeks
timeFrame: Baseline to 6 weeks follow-up
measure: change in line managers confidence to create a mentally healthy workplace from baseline to 3 months
timeFrame: Baseline to 3 months follow-up
measure: change in line managers confidence to create a mentally healthy workplace from baseline to 6 months
timeFrame: Baseline to 6 months follow-up
Secondary outcomes:
measure: change in line manger mental health knowledge from baseline to 6 weeks
timeFrame: Baseline to 6 weeks follow-up
measure: change in line manger mental health knowledge from baseline to 3 months
timeFrame: Baseline to 3 months follow-up
measure: change in line manger mental health knowledge from baseline to 6 months
timeFrame: Baseline to 6 months follow-up
measure: change in line manager workplace mental health literacy from baseline to 6 weeks
timeFrame: Baseline to 6 weeks follow-up
measure: change in line manager workplace mental health literacy from baseline to 3 months
timeFrame: Baseline to 3 months follow-up
measure: change in line manager workplace mental health literacy from baseline to 6 months
timeFrame: Baseline to 6 months follow-up
measure: change in line manager self-rating of behaviour from baseline to 6 weeks
timeFrame: Baseline to 6 weeks follow-up
measure: change in line manager self-rating of behaviour from baseline to 3 months
timeFrame: Baseline to 3 months follow-up
measure: change in line manager self-rating of behaviour from baseline to 6 months
timeFrame: Baseline to 6 months follow-up
measure: change in employee well-being from baseline to 3 months
timeFrame: Baseline and 3 months follow-up
measure: change in employee well-being from baseline to 6 months
timeFrame: Baseline and 6 months follow-up
measure: change in employee rating of line manager behaviour from baseline to 3 months
timeFrame: Baseline and 3 months follow-up
measure: change in employee rating of line manager behaviour from baseline to 6 months
timeFrame: Baseline and 6 months follow-up
measure: change employee sickness absence baseline to 6 months
timeFrame: Baseline and 6 months follow-up
measure: change in employee productivity from baseline to 3 months
timeFrame: Baseline and 3 months follow-up
measure: change in employee productivity from baseline to 6 months
timeFrame: Baseline and 6 months follow-up
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Louise Thomson, PhD
role: PRINCIPAL_INVESTIGATOR
References: