Condition category
Mental and Behavioural Disorders
Date applied
05/01/2017
Date assigned
09/01/2017
Last edited
06/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Since the end of conflict in 2009, Northern Sri Lanka has an increased need to rebuild the health system. Currently, there is a lack of human resources, as the amount of new healthcare professionals being trained is below that of the growing need in the region. The relative political, social and economic stability in the region is favorable to training new healthcare workers and increasing the capacity of existing health work force. The proposed project, already applied in small pilot study in the Northern Province, aims to improve the skills of existing primary care health work force by adding mental health care into primary care services (first port of call) across all districts of the province.

Who can participate?
Primary Care Practitioners (doctors), Public Health Professionals (such as nurses and health service assistants) working at participating centres for at least six months, community representatives, and adult patients attending participating centres who are from areas of conflict.

What does the study involve?
25 primary care facilities are randomly selected across all 5 districts of Northern Province. All selected facilities are monitored for a period of one month. Each facility receives training over the course of one week and then monitoring for a month, which they receive staggered one week apart. The order that facilities receive this is randomly selected. Primary care practitioners and public health professionals in primary care facilities across the Northern Province are invited to attend a three-day training, which involves role-plays, videos and seminars using material developed by the World Health Organization. Once trained, they are asked to use their training to diagnose, treat and refer patients with possible mental health problems. Patients of trained primary care practitioners are asked to answer some questions about their mental health problems and visit a psychiatrist to confirm their diagnosis and received treatment as required. Public health professionals are asked to engage activities such as stigma (negative associations) reduction, enabling referrals and follow-up and supporting community representative-led community engagement activities. Community representatives from the areas near each primary care facility will be invited to a one-day training course and afterwards are asked to help raise awareness, find local resources and organise mental health promotional activities, such as play and group activities in their communities. There are two refresher courses for primary care practitioners, public health professionals and community representatives 3 and 6 months after the first training course.

What are the possible benefits and risks of participating?
The long-term benefits of this project will be an increase of the mental wellbeing of the population, enabling people to live happier, healthier lives and to increase knowledge, skills and education levels of the public health workforce in the Northern Province. Community awareness programmes are also part of the project, to increase mental health knowledge among the general public, students and other professionals in the region, and help to reduce stigma (negative views) around mental illnesses. There are no foreseeable risks for any participants taking part in this study.

Where is the study run from?
The study is run from the THEME Institute and takes place in 25 primary care facilities located across 5 districts of the Northern Province of Sri Lanka (Sri Lanka)

When is the study starting and how long is it expected to run for?
September 2016 to August 2018

Who is funding the study?
Centers for Disease Control and Prevention (USA)

Who is the main contact?
1. Dr Chesmal Siriwardhana (scientific)
chesmal.siriwardhana@lshtm.ac.uk
2. Ms Shannon Doherty (public)
shannon.doherty@anglia.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chesmal Siriwardhana

ORCID ID

http://orcid.org/0000-0003-3614-9088

Contact details

Room 142B
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 20 7299 4671
chesmal.siriwardhana@lshtm.ac.uk

Type

Public

Additional contact

Ms Shannon Doherty

ORCID ID

http://orcid.org/0000-0002-6123-1238

Contact details

2nd Floor
PMI
Faculty of Medical Science
Anglia Ruskin University
Bishop Hall Lane
Chelmsford
CM1 1SQ
United Kingdom
+44 845 196 3154
shannon.doherty@anglia.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

COMGAP-S/Y2

Study information

Scientific title

Integrating mental health into primary care for COnflict-affected internal forced Migrants in Northern Sri Lanka using WHO mhGAP intervention (COMGAP-S)

Acronym

COMGAP-S

Study hypothesis

The aim of this study is to:
1. Integrate mental health into primary care by providing training to PCP and Public Health Personnel (PHP) serving conflict-affected populations in resource-poor, primary care settings in the Northern Province via a scaled-up training intervention based on World Health Organization mental health gap programme (WHO mhGAP 2.0)
2. Enhance community awareness, reduce stigma and to improve psychosocial well-being of local communities by including community representatives (CR) in the training intervention

Ethics approval

Not provided at time of registration

Study design

Multi-centre stepped wedge cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mental disorders

Intervention

Primary Care Practitioners (PCP) at randomly selected facilities will be monitored for 1 month prior to commencement of training. In two week intervals PCPs will then receive a 3-day training intervention based on the World Health Organization mhGAP 2.0 training module. Key modules informed by previous work on depression, stress related disorders, medically unexplained symptoms, alcohol/drug use disorder, and others will be used. All materials will be locally translated and adapted. Training will occur in selected primary care facilities located across the Northern Province. Once training is completed, PCPs will use the mhGAP guide to diagnose, treat and refer primary care patients with possible mental health problems. Those who haven’t yet received training will act as controls and will continue treatment as usual. Pre- and post-knowledge tests will be carried out at 3 and 6 months after initial training. After training is completed PCPs will be monitored for a period of 1 year. Standardized randomization techniques will be used to randomize facilities to the sequence of receiving training within the stepped wedge design.

Public Health Professionals (PHP) at randomly selected facilities will be monitored for 1 month prior to commencement of training. In two week intervals PCPs will then receive a 3-day training intervention based on the World Health Organization mhGAP 2.0 training module. Key modules informed by previous work on depression, stress related disorders, medically unexplained symptoms, alcohol/drug use disorder, and others will be used. All materials will be locally translated and adapted. Once training is completed, PHPs will engage in specific activities outlined during their training with the patient population attending their respective facilities. Those who haven’t yet received training will act as controls and will continue treatment as usual. Pre- and post-knowledge tests will be carried out at 3 and 6 months after initial training. After training is completed PHPs will be monitored for a period of 1 year. Standardized randomization techniques will be used to randomize facilities to the sequence of receiving training within the stepped wedge design.

Community Representatives (CR) will not be randomized. CR within the catchment area of each randomly selected primary care facility will be identified and approached for inclusion. CR will receive a 1-day training intervention based on the World Health Organization mhGAP 2.0 training module. Key modules informed by previous work on depression, stress related disorders, medically unexplained symptoms, alcohol/drug use disorder, and others will be used. All materials will be locally translated and adapted. Once training is completed, CRs will engage in specific activities outlined in their training within their respective communities such as creating awareness, finding local resources and organizing mental health promotional activities. Pre- and post-knowledge tests will be carried out at 3 and 6 months after initial training. After training is completed CRs will be monitored for a period of 1 year.

Patients attending primary care facilities who are identified by mhGAP trained primary care practitioners will be asked to answer a brief socio-demographic questionnaire at point of recruitment along with the Hopkins Symptoms Checklist and the Harvard Trauma Questionnaire at point of recruitment and at 3 and 6 months follow up. They will also be re-examined by a psychiatrist to confirm the primary care practitioner diagnosis.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Successful uptake of mhGAP 2.0 training is measured using minimum 40% concurrence increase of primary care practitioners who correctly diagnose patients with common mental disorders as verified by specialist psychiatrists at 1 year.

Secondary outcome measures

Successful integration of mental health services into primary care is measured by reaching a 40% rate of mhGAP 2.0 trained primary care practitioners in the Northern Province at 1 year.

Overall trial start date

01/09/2016

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Primary Care Practitioners (PCP)
1. Full registration with the Sri Lankan Medical Council
2. At least 6 months or more until their next transfer rotation (this applies only for PCP working in government facilities) or 6 months to retirement

Public Health Personnel (PHP)
1. Nurse, attendant or health service assistant within each facility
2. At least 6 months left on their transfer rotation (this applies only for PHP working in government facilities) or 6 months to retirement

Community Representatives (CR)
1. Located within the catchment area of each selected facility

Patients
1. Aged 18 years or older
2. Attend selected facilities
3. Belong to IDP or post-conflict populations

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

25 facilities (cluster): 25 PCPs total, 1 in each cluster; 75 PHPs total, 3 in each cluster; 50 CRs total, 2 in each cluster; 325 patients total, 13 in each facility

Participant exclusion criteria

Primary Care Practitioners (PCP)
Those who have secondary mental health training.

Public Health Personnel (PHP)
Those who have secondary mental health training.

Community Representatives (CR)
Those who have secondary mental health training.

Patients
1. Aged under 18 years
2. Diagnosed with serious mental disorders (e.g. schizophrenia, bipolar disorder)

Recruitment start date

01/04/2017

Recruitment end date

30/04/2017

Locations

Countries of recruitment

Sri Lanka

Trial participating centre

THEME Institute
No. 190, Galle Road
Colombo
04
Sri Lanka

Sponsor information

Organisation

Anglia Ruskin University

Sponsor details

Faculty of Medical Science
Anglia Ruskin University
Bishop Hall Lane
Chelmsford
CM1 1SQ
United Kingdom
+44 845 196 3154
shannon.doherty@anglia.ac.uk

Sponsor type

University/education

Website

http://www.anglia.ac.uk/medical-science

Funders

Funder type

Government

Funder name

Centers for Disease Control and Prevention

Alternative name(s)

CDC

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Protocols, results and other data from the proposed project will result in manuscripts that will be made publicly available on PubMed Central (PMC) and OpenAccess journals to ensure widespread dissemination of material. All epidemiological data including datasets and digitally recorded factual material will be shared and/or released as defined by the CDC Data Policy. Data can then be disseminated, subject to confidentiality, technology, data quality, resources and limits imposed by law. Files deemed public use may be deposited in appropriate repositories while restricted use files may only be released to appropriate secure data centers.
All data will be released and/or shared in such a way as to maximize public access without charge and to ensure data is readily available to qualified individuals in the scientific communities for research purposes. Data will also be disseminated through the research project team at international conferences and networking meetings as well as through preliminary results reports disseminated to participants at the conclusion of the study.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes