Home » Trials » SLCTR/2019/005

Prevalence and associated factors of occupational stress and the effectiveness of an intervention to manage it among bus drivers of Sri Lanka Transport Board in Colombo district


SLCTR Registration Number


Date of Registration

01 Feb 2019

The date of last modification

Aug 24, 2019

Application Summary

Scientific Title of Trial

Prevalence and associated factors of occupational stress and the effectiveness of an intervention to manage it among bus drivers of Sri Lanka Transport Board in Colombo district

Public Title of Trial

Study on the usefulness of a stress management program to reduce occupation related stress among bus drivers working at the Sri Lanka Transport Board in Colombo district, Sri Lanka

Disease or Health Condition(s) Studied

Occupational health

Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

Approved by Ethics Review Committee, Faculty of Medicine, University of Colombo on 18th October 2018 (Ref. No:EC-18-098)

Trial Details

What is the research question being addressed?

Could an intervention addressing occupation stress reduce stress among bus drivers of the Sri Lanka Transport Board in the Colombo district?

Type of study


Study design


Randomized controlled trial


Single blinded







Study Phase

Not Applicable

Intervention(s) planned

Study setting – All the SLTB depots in Colombo district. Each depot will be considered as a cluster. 6 depots will receive the intervention while other 6 will remain as control. Depots (clusters) will be selected to each arm by simple randomization.

Intervention: Drivers in the intervention group will be divided into 2 groups. Both group 1 and 2 will consist of 36 drivers. The intervention consists of 6 modules. The first 4 modules are based on concepts of emotional intelligence namely self awareness, self management, community awareness and community management. (It covers the health promotion action area-empowerment and skill development.) Last two modules cover the action areas of health promotion namely supportive environment and sustainability. Each activity session lasts for 2-4 hours and will be conducted once per week for both groups during the 1st,2nd,3rd,5th and 6th month. The 4th month will be free of activities, which will enable them to practice what they learnt and put it into action. It allows them to verify doubts and share experience in the 5th and 6th months. In the last month, a talent show and reassessment of the primary and secondary outcomes will be measured by the respective questionnaires. Activities will be conducted by the principal investigator, a consultant psychiatrist, psychologist and a counselor, a sociologist, and a meditation practitioner from a Buddhist organization.

Bus drivers in the control group will be the active control. Only the participants will be blinded.

Inclusion criteria

  1. All the SLTB bus drivers who are working only as bus drivers on full time, permanent basis in buses commencing from their relevant depots in Colombo district
  2. Having scores above the cut off marks indicating occupational stress using the questionnaire – Effort-Reward Imbalance model. It has three subscales namely Effort, reward and overcommitmentThe cut off mark for occupational stress level will be calculated using following formula. Effort rewards Ratio = E/R XC. E=Sum of score of the effort scale.R= Sum of score of the reward scale. C=Is a correction factor=0.545. Values beyond 1.0 takes as occupational stress. Overcomittment considered separately as an association with this cutoff value.

Exclusion criteria

  1. Bus drivers who are engaged in temporary basis, emergency services and who are engaged in Luxury fleets.
  2. Bus drivers who have been diagnosed as suffering from mental illness.

Primary outcome(s)


the level of occupational stress, pre and post intervention. The level of stress will be measured using the tool ‘Effort-Reward Imbalance model’.


6 months after the commencement of the intervention


Secondary outcome(s)


Engaged in road rage perpetration activities more than monthly over the last 3 months would be considered positive for perpetration of road rage.

Road rage will be assessed using the road rage questionnaire.


6 months after the start of the intervention


Target number/sample size

72 participants for each study group and control group

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment


Date of study completion

Recruitment status


Funding source


Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Registrar in Community Medicine
Health Promotion Bureau, No2, Kynsey Road,Colombo 08
011-2692613 (Office)
www.healthedu.gov.lk (Office)

Contact Person for Public Queries

M.A.A.P Alagiyawanna
Consultant Community Physician
Health Promotion Bureau, No2, Kynsey Road, Colombo 08


Primary study sponsor/organization

Health Promotion Bureau

No2, Kynsey Road,Colombo 08
011-2692613 (Office)
www.healthedu.gov.lk (Office)

Secondary study sponsor (If any)


Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Individual participant data that underlie the results will be shared after the de-identification (tables,figures,appendices). This will be immediately following publication (no end date). Data sharing will be with investigators whose proposed use of the data has been approved by an independent review committee/ethical review committee identified for this purpose, to achieve the aims of the approved proposal. Proposals should be directed to dhananjachami@gmail.com and ajithalagie@yahoo.com

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results