Home » Trials » SLCTR/2013/025
An intervention to improve mental health care for conflict-affected forced migrants in low-resource settings: A WHO MhGAP based pilot study in primary care setting in Sri Lanka
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SLCTR Registration Number
SLCTR/2013/025
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
An intervention to improve mental health care for conflict-affected forced migrants in low-resource settings: A WHO MhGAP based pilot study in primary care setting in Sri Lanka
Public Title of Trial
Improving primary mental health care for forced migrants through training primary care practitioners in Sri Lanka: a feasibility pilot study
Disease or Health Condition(s) Studied
Depression, Medically unexplained symptoms, Alcohol use disorders, Suicidal ideations
Scientific Acronym
COM-GAP
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
730/13 (Ethics review committee of Faculty of Medical Sciences, University of Sri Jayawardenepura)
What is the research question being addressed?
Will WHO mhGAP IG (mental health Gap Action Programme - Intervention Guide) based training for primary care practitioners (PCP) increase rates of correct identification, treatment and specialist referral of patients with common mental disorders (CMD) among conflict-affected forced migrants in low-resource settings?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Available
Intervention(s) planned
The study will be carried out in primary care settings in Puttalam and Mannar districts of Sri Lanka,
All PCPs recruited to the study will be randomized to intervention and control arms. All will be provided an initial training on ethics and informed consent process.
Both arms will be monitored for 90 days. During this period, all PCPs will be required to immediately inform the study coordinator upon diagnosing a primary care patient with CMD.
Training based on WHO mhGAP IG will then be provided to the intervention arm. Only relevant modules (depression, medically unexplained symptoms, alcohol abuse and suicide) will be used. Training will take place on a full day basis for five days.
Both arms will then be monitored for another 90 days. All PCPs will be required to immediately inform the study coordinator upon diagnosing a primary care patient with CMD. There will be no randomization of patients into the two arms of the study.
Patients will be approached individually and consenting patients will be directed to the study psychiatrist, who will re-assess them based on mhGAP-based criteria for concurrence with the initial PCP diagnosis.
For those patients categorised as referrals to specialist care, treatment and management will be provided by the study psychiatrist unless preferred otherwise by the patients.
The study psychiatrist will be blind/masked to the randomization status of PCP. In addition, patients will also be blind to the PCP randomization status.
At the end of the study, the training intervention will be provided to PCPs in the control arm.
Inclusion criteria
For PCPs. 1. At least 5 years’ service 2. Full registration with the Sri Lanka Medical Council 3. Provision of primary care to IDP populations at least four hours a day.
For the patients 1. Meet the definition of an IDP (specifically, Northern Muslims) 2. 18 years or older
Exclusion criteria
For PCPs 1. Psychiatrists, 2. Having secondary mental health training
For patients 1. Existing diagnosis of a serious mental disorders
Primary outcome(s)
|
1.
Referral rates |
[ Continuously until the end of the second 90 day observation period ] |
|
2.
Rates of study psychiatrist verified diagnosis |
[ At the time of each patient recruitment ] |
|
3.
Quality of adherence to mhGAP guidelines |
[ At the end of the first and second 90 day observation period ] |
|
4.
Change in knowledge levels (using mhGAP IG pre/post training tests) |
[ At PCP recruitment to study, at first day of training, at last day of training and at end of study. ] |
Secondary outcome(s)
|
1.
Attitudes, views and perceptions of PCP on integrating mental health in to primary health care (using qualitative methods) |
[ At the time of recruitment of PCPs ] |
|
2.
Economic evaluation (using Client Receipt Service Inventory) |
[ At recruitment and at the end of the second 90 day follow up period ] |
|
3.
Total cost of training PCP and service provision costs |
[ At the end of the second 90 day follow up period ] |
|
4.
CMD outcomes of patients |
[ At the end of the second 90 day follow up period ] |
Target number/sample size
43 PCP for each arm (total of 86) [feasibility study]
Countries of recruitment
Sri Lanka
Anticipated start date
2013-09-01
Anticipated end date
2014-08-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
SHARE consortium, supported by the NIMH grant number 1U19MH095687-01
Regulatory approvals
Status
Approved
Date of Approval
2013-05-27
Approval number
730/13
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Chesmal Siriwardhana
Research Fellow
Institute for Research & Development, 393/3, Lily Avenue, Off Robert Gunawardene Mw, Battaramulla, Sri Lanka
+94 112 863084
+94 112 863084
chesmal@gmail.com
Contact Person for Public Queries
Dr Athula Sumathipala
Senior Lecturer, Department of Health Service and Population Research, Kings College London and Director Institute for Research and Development, Sri Lanka
Institute for Research & Development, 393/3, Lily Avenue, Off Robert Gunawardene Mw, Battaramulla, Sri Lanka
+94 112 863084
+94 112 863084
athula.sumathipala.kcl.ac.uk
Primary study sponsor/organization
Institute for Research & Development
393/3, Lily Avenue, Off Robert Gunawardene Mw, Battaramulla, Sri Lanka
+94 112 863084
+94 112 863084
forum4research@gmail.com
www.ird.lk
Secondary study sponsor (If any)
South Asia Hub for Advocacy, Research and Education in Mental Health (SHARE) Consortium.
http://www.centreforglobalmentalhealth.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
