Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310474721238 Date of Approval: 06/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Development of a model intervention for stress prevention, management, and coping mechanism among police officers in Nigeria
Official scientific title Development of a model intervention for stress prevention, management, and coping mechanism among police officers in Nigeria
Brief summary describing the background and objectives of the trial Policing is a stressful occupation. Police officers are exposed to stressors that are inherent in the organization and operations of the police as a law enforcement institution. As it is common with their counterparts around the world, many Nigerian police officers are exposed to high levels of stress, making them vulnerable to stress-related mental health conditions including depression, anger disorder, mood swing, burn-out, Post-Traumatic Stress Disorders (PTSD), and suicidal ideation which are also risk factors for cardiovascular conditions such as hypertension and abdominal obesity. Despite these risks and their consequences to the health and safety of police officers and the larger society, interventions are currently not available to address this challenge in Nigeria. The current study is designed to address this gap in knowledge. The aim of the study is to assess the burden of stress and related mental health condition among a randomly selected national sample of police officers and implement a pilot intervention to mitigate the burden. The study has three phases: (1) a national survey to determine prevalence of stress and mental health burden among police officers in four randomly selected states namely Bauchi, Nasarawa, Akwa-Ibom, and Oyo, in the four geo-political zones (North East, North Central, South-south, and South west respectively) of the country (2) implementation of a package of intervention in Oyo state which will be informed by data from the national survey and (3) an evaluation to determine outcomes and lessons learnt. A mixed method approach, involving collection of quantitative and qualitative data from 1,240serving junior and senior police officers will be adopted. The study is significant for three reasons. First, unlike previous studies which have small sample sizes and localized, the design of our proposed study is robust in the sense that it is national in scope with both cross-sectional and intervention components. Findings from the current study will be used to inform policy review on how to prevent and manage stress among police officers and integrate mental health care into existing police medical services in the intervention site. This is feasible because the research includes a plan for a dissemination agenda using evidence-driven advocacy targeting the policy stakeholders in the Nigeria Police Force including the Police Service Commission and the National Assembly. Second, a participatory approach will be adopted in the process of developing appropriate, realistic stress prevention and management of the pilot interventions which can be scaled-up and ensure their sustainability. Finally, the successful implementation of a stress prevention and management strategy will enhance the policing role of officers, thus contributing to the safety of the communities they serve.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2023
Actual trial start date
Anticipated date of last follow up 01/10/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Peer led support group intervention We aim to have 8 modules that will be delivered in fortnightly sessions over a period of two months with each session lasting approximately 30 minutes. Two months General sensitization and Peer led support group intervention A general sensitization meeting will be held with the rank and file of police officers to inform them about the pilot intervention in the state. The sensitization will include a general discussion of cause of stress, prevention, and management. The sensitization meeting will be held during one of the monthly meetings convened by the Commissioner of Police where all police personnel in the state typically attend. To improve the chances of uptake and widespread dissemination of the intervention, we shall make use of evidence-based peer-led team-based format adapted from an earlier programme of safety and health improvement for law-enforcement officers (The SHIELD) study carried out in the US (Kuehl et al., 2014; 2016). A peer-led intervention is proposed because interventions delivered by peers are credible and can be sustained. The research team will develop a curriculum that is aimed at empowering trainees with knowledge and skills on stress prevention and management. We will aim to have no more than 8 modules that can be delivered in fortnightly sessions over a period of two months with each session lasting approximately 30 minutes. We will pilot test this intervention using a cluster randomized controlled trial (cRCT) design (See Figure 3). While the police formation will be the unit for randomization, outcome assessment will be conducted on individual participants (police officers). cRCT is justified based on the format for the delivery of the interventions to groups of police officers selected on the basis of the usual team/ office-based distribution of police officers (police formation). Eligible police formations (that is formations with a team of officers made up of a minimum of 10 men/women) will be stratified based on location (rural versus urban) to reflect the distribution of the State police com 100
Control Group General sensitization only Once One hour A general sensitization meeting will be held with the rank and file of police officers to inform them about the pilot intervention in the state. The sensitization will include a general discussion of cause of stress, prevention, and management. The sensitization meeting will be held during one of the monthly meetings convened by the Commissioner of Police where all police personnel in the state typically attend. 100 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Informed consent and willingness to participate in the study. 2. Serving as a full-time police officer in the division 3. Attachment to a defined police formation. 4. Schedule that involves direct interactions with the community members. 5. Availability throughout the period of the research work. 1) Police officers on medical admission 2) Police officers who have very irregular work schedule due to their assignment or postings 3) Police officers deployed to other states or regions outside their primary postings Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/04/2023 National Health Research Ethics Committee of Nigeria
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health, Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja P.M.B. 083, Garki-Abuja Abuja 22222221 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effectiveness of the intervention will be assessed using reduction in stress levels (measured on the Perceived Stress Scale (PSS) and the Maslach Burnout Inventory (MBI)), improved knowledge about stress management and mental disorders (based on pre and post test questions for each session of the training curriculum) and psychological distress (measured using the World Health Organization 20-item Self-Reporting Questionnaire (SRQ-20). 0 months, 2 months and 6 months
Secondary Outcome Feasibility and acceptability of the interventions 2 months and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Police divisions in Ibadan Eleyele Ibadan Nigeria
Police divisions oYO TOWN Afijio Oyo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
TERTIARY EDUCATION TRUST FUND NO 6 Zambezi Crescent, Off Aguiyi Ironsi Street, Maitama, Abuja, FCT Nigeria Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor TERTIARY EDUCATION TRUST FUND NO 6 Zambezi Crescent, Off Aguiyi Ironsi Street, Maitama, Abuja, FCT Nigeria Abuja Nigeria Government
COLLABORATORS
Name Street address City Postal code Country
Dr Musibau Titiloye Department of Health Promotion and Education, Faculty of Public Health, University of ibadan Ibadan Nigeria
Dr Bibilola Oladeji Department of Psychiatry, Faculty of Clinical Science, University of Ibadan Ibadan Nigeria
Dr Mojisola Oluwasanu Department of Health Promotion and Education, Faculty of Public Health, University of Ibadan Ibadan Nigeria
Dr Olayinka Adefolarin Department of Health Promotion and Education, Faculty of Public Health, University of Ibadan Ibadan Nigeria
Dr Mackson Unogu Police Hosptai, Police State Command, Eleyele Ibadan Nigeria
Dr Patrick Okafor Police Hosptai, Police State Command, Eleyele Ibadan Nigeria
Mr Tobi Hussain Department of Health Promotion and Education, Faculty of Public Health Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ademola Ajuwon ajajuwon@yahoo.com +2348034892561 Department of Health Promotion and Education, Faculty of Public Health, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Bibilola Oladeji bibideji@yahoo.com +2348023324989 Department of Psychiatry, Faculty of Clinical Sciences, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Musibau Titiloye titiloyemusibau@gmail.com +2348033775285 Department of Health Promotion adn Education, Faculty of Public Health, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Lecuter
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the articles published from the study will be available after deidentification. The study protocol will be published. The deidentified data will available beginning 12 months and ending 36 months following the publication of articles. These data will only be provided to investigators whose proposed use of the data has been approved by an independent review committee. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Proposals should be submitted to the Principal Investigator (ajajuwon@yahoo.com) Statistical Analysis Plan,Study Protocol Within 12 months of the study completion date Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact ajajuwon@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information