- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02376062
Bundled Intervention Integrating Mental Health Services in Nepal
December 4, 2017 updated by: Possible
Bundled Intervention Integrating Mental Health Service Into Rural Primary Care in Nepal: Implementation Research Study
Globally, access to mental healthcare is often non-existent in rural, resource-deprived communities despite the pervasive need for services, particularly in post-conflict and post-disaster settings.
We are developing and piloting will develop and pilot a culturally appropriate training model for non-specialist providers (NSPs) to deliver high-quality mental health care over a period of 24 months in a primary care hospital in a rural district in Nepal.
We will employ a mixed methods framework to evaluate change in skills, knowledge, and attitude in NSP's, identify key mechanisms for continuum of mental healthcare delivery, and efficacy and cost-effectiveness in care delivery through a government hospital, clinics, and a network of community health workers.
This integrated approach will introduce a bundled intervention that includes: both an on-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu, weekly case conferences, and surveys of NSP's and clinical supervisors every six months during the study period.
To learn about the acceptability, feasibility and challenges in the program we will also conduct Focus Group Discussions among the PCPs.
In the last one year of the research in Achham District we have seen increase in knowledge efficacy and skills among the NSPs and also improved mental health care services at Bayalpata Hospital.
Our experience in Achham motivated us to develop a similar program for Charikot Primary Health Center in Dolakha District.
Outcomes of this study will focus on efficacy of this model to appropriately identify, counsel, and treat patients with depression, psychosis, and post-traumatic stress disorder (PTSD) through an integrated rural mental healthcare delivery intervention as a model for rural healthcare delivery.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
225
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Achham
-
Sanfebagar, Achham, Nepal
- Bayalpata Hospital
-
-
Dolakha
-
Bhimeshwor, Dolakha, Nepal
- Charikot Primary Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary Care Provider (MBBS-level physician or Health Assistant)
- Current staff at healthcare facility in Achham, Bajura, or Doti Districts.
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bundled Intervention
|
The authors have designed continuing medical education curriculum to improve clinical capacity and competency about mental health for Nepali Primary Care Providers. Specifically:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in knowledge, attitudes, practices, and self-efficacy of Primary Care Providers
Time Frame: 3 years
|
To measure retention of knowledge, and change in attitudes, practices, and self-efficacy among primary care providers who take part in the integrated mental health care delivery intervention.
The primary outcome will be reported as change in scores for all pre-and post-tests will be scored with a total score of 100 on each module.
Self-efficacy will be assessed on a Likert Scale.
Change in knowledge and self-efficacy before and after the intervention will be compared with wilcoxon rank sum tests, assuming lack of normal distribution and given the small sample size.
Trainee's rating of the module will be on a Likert scale from 1-5 and these will be presented as means with standard deviation.
|
3 years
|
Longitudinal clinical outcomes for patients with depression, post-traumatic stress disorder, and patient self-reported medication adherence
Time Frame: 3 years
|
To analyze the longitudinal clinical outcomes related to a decrease in acute symptoms as measured by PHQ-9 and PCL, regular adherence to medication and counseling as appropriate.
The primary outcome will be reported as the difference in means of the PHQ-9 scores (depression) or PCL scores (post-traumatic stress disorder) before and after the length of the intervention.
For patients who are lost of follow-up, the last observation will be carried forward.
For patient self-reported medication adherence, the primary outcome will be patient self reported rates of medication adherence, based on a "Yes" response to the question "Have you been able to take your medications as prescribed almost all the time?".
|
3 years
|
Cost assessment of bundled intervention
Time Frame: 3 years
|
To assess the costs and scalability of the bundled intervention through mixed quantitative and qualitative methods.
We will include the following expenses aggregated to per patient per year psychotropic medications, time effort for PCPs, psychosocial counselors, consultant psychiatrist and nurses, and laboratory and other diagnostic tools.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: David Citrin, PhD, MPH, Possible
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2016
Primary Completion (Anticipated)
July 30, 2019
Study Completion (Anticipated)
July 30, 2019
Study Registration Dates
First Submitted
December 31, 2014
First Submitted That Met QC Criteria
February 24, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Actual)
December 6, 2017
Last Update Submitted That Met QC Criteria
December 4, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- MHCMEnyaya
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health
-
Chinese University of Hong KongNot yet recruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
National Taiwan Normal UniversityCompletedMental Health | Physical HealthTaiwan
-
Virginia Commonwealth UniversityCompletedMental Health DisordersUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
University of WarwickKing's College London; KU Leuven; University Hospital, Montpellier; Erasmus Medical... and other collaboratorsUnknownMental Health Disorder | Mental Health ImpairmentIreland, United Kingdom, Netherlands, Germany, Belgium, Croatia, France, Italy
-
York UniversityCanadian Institutes of Health Research (CIHR); North York General HospitalCompletedMental Health DisordersCanada
Clinical Trials on Bundled Intervention
-
Duke UniversityKimberly-Clark CorporationCompleted
-
PossibleNyaya Health Nepal; Ministry of Health and Population, NepalWithdrawnHypertension | Diabetes Mellitus, Type 2 | Chronic Obstructive Pulmonary Disease | Noncommunicable DiseasesNepal
-
New York City Health and Hospitals CorporationCompletedHepatitis C | HIV/AIDS | Hiv | HCV Coinfection | HIV/AIDS and InfectionsUnited States
-
University of FloridaNational Cancer Institute (NCI)Active, not recruiting
-
Hartford HospitalVygon GmbH & Co. KGNot yet recruitingCatheter Complications
-
Amy FinkelsteinUniversity of Chicago; Dartmouth College; Harvard UniversityCompletedArthroplasty, Replacement
-
Columbia UniversityNational Institute on Drug Abuse (NIDA); New York University; Beth Israel Medical...CompletedSubstance-related DisordersUnited States
-
Seoul National University HospitalTerminatedOut-of-Hospital Cardiac ArrestKorea, Republic of
-
University of PittsburghNational Institute of Nursing Research (NINR)RecruitingMaternal Death | Severe Maternal MorbidityUnited States