Home » Trials » SLCTR/2018/008
Conducting operational research to identify numbers and rates, determine needs, and integrate services to mitigate morbidity and mortality among internally displaced persons affected by emergencies
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SLCTR Registration Number
SLCTR/2018/008
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Conducting operational research to identify numbers and rates, determine needs, and integrate services to mitigate morbidity and mortality among internally displaced persons affected by emergencies
Public Title of Trial
Integrating mental health into primary care for post-conflict populations in Northern Sri Lanka (COMGAP-S)
Disease or Health Condition(s) Studied
Mental disorders
Scientific Acronym
COMGAP-S (COnflict-affected Migrants mhGAP Study)
Public Acronym
COMGAP-S (COnflict-affected Migrants mhGAP Study)
Brief title
None
Universal Trial Number
U1111-1196-4127
Any other number(s) assigned to the trial and issuing authority
ISRCTN62598070; UK:Faculty Research Ethics Panel Faculty of Medical Science Anglia Ruskin University, 19/1/2017, ref:SC/jc/FMSFREP/16/17076; Sri Lanka:Ethics Review Committee Faculty of Medicine University of Jaffna, 4/1/2018, Ref:J/ERC/17/81/NDR/0170
What is the research question being addressed?
What are the changes in knowledge and skills on identification, treatment/management and referrals of mental disorders among primary care practitioners who have been trained to use a locally adapted version of the WHO mhGAPprogramme compared to existing standard of care?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Other
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study settings: 25 primary care facilities across all 5 districts of the Northern Province, Sri Lanka
Method of allocation: Multi-centre stepped wedge cluster randomised trial
Intervention
Primary care practitioners: Primary Care Practitioners (PCP) at randomly selected facilities will be monitored for 1 month prior to commencement of training. They will receive 3 days training, 6 hours a day, 1-on-1 training using locally adapted WHO mhGAP intervention guide. Once training is completed, PCPs will use the mhGAP guide to diagnose, treat and refer primary care patients with possible mental health problems.
Public health professionals (PHPs): 2 days training in groups of 3, 6 hours a day using locally adapted educational material on mental health awareness and stigma reduction. Once training is completed, PHPs will engage in specific activities outlined during their training with the patient population attending their respective facilities.
Community representatives (CRs): 1 day training in groups of 2 or more, 6 hours total, using locally adapted educational material on mental health awareness and stigma reduction. 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. 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.
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 (for depression and anxiety) 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.
All training interventions will be 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 have been locally translated and adapted.
After training is completed PCPs, PCPs and CRs will be monitored for a period of 1 month.
Pre- and post-knowledge tests and refresher courses will be carried out at 3 and 6 months after initial training.
PCPs, PHPs, CRs who haven’t yet received training, and their patients will act as controls and will continue treatment as usual.
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
Exclusion criteria
Primary care practitioners, public health professionals and community representatives will be excluded if they have secondary mental health training. Patients will be excluded if they are under 18 years or diagnosed with mental disorders other than depression and/or anxiety.
Primary outcome(s)
1.
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. |
[ 1 month after completion of mhGAP 2.0 training ] |
Secondary outcome(s)
1.
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. |
[ 1 year after completion of mhGAP 2.0 training ] |
Target number/sample size
25 facilities (cluster): 25 PCPs total, 1 in each cluster; 75 PHPs total, 3 in each cluster; 50 CRs total, 2 in each cluster; 200 patients total, 8 in each facility
Countries of recruitment
Sri Lanka
Anticipated start date
2018-03-13
Anticipated end date
2019-10-31
Date of first enrollment
2018-03-16
Date of study completion
Recruitment status
Recruiting
Funding source
Centers for Disease Control and Prevention, United States of America (Cooperative Grant Number 1U01GH001654)
Regulatory approvals
Status
Approved
Date of Approval
2018-04-01
Approval number
J/ERC/17/81/NDR/0170
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Jaffna |
Institutional Address: | ERC Office, Faculty of Medicine, University of Jaffna, Adiyapatham Road, Kokuvil, Jaffna Sri Lanka |
Telephone: | +94-212222073 (Extension: 342) |
Email: | ercmedjfn@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Shannon Doherty
Principal Investigator
Bishop Hall Lane
Chelmsford, United Kingdom
CM1 1SQ
Tel: +448451963154
Mob: +447522128409
shannon.doherty@anglia.ac.uk
globalhme.org
Contact Person for Public Queries
Ms. Giselle Dass
Senior Research Associate
THEME Institute
81/7, Pagoda Road
Nugegoda
Colombo
Tel: +94 11 7446919
giss.dass@gmail.com
globalhme.org
Primary study sponsor/organization
Anglia Ruskin University
Primary study organization
Bishop Hall Lane
Chelmsford, United Kingdom
CM1 1SQ
http://www.anglia.ac.uk/medical-science
Secondary study sponsor (If any)
THEME Institute
Secondary study organization
49/c/3 Gemunu Mawatha
Athurugiriya, Sri Lanka
Tel: +94117446919
themeinstitute.sl@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results