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Bundled Intervention Integrating Mental Health Services in Nepal

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ClinicalTrials.gov Identifier: NCT02376062
Recruitment Status : Enrolling by invitation
First Posted : March 3, 2015
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
University of California, San Francisco
Harvard Medical School Center for Global Health Delivery-Dubai
National Institute of Mental Health (NIMH)
Brigham and Women's Hospital
Information provided by (Responsible Party):
Possible

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mental Health Other: Bundled Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bundled Intervention Integrating Mental Health Service Into Rural Primary Care in Nepal: Implementation Research Study
Actual Study Start Date : February 6, 2016
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Bundled Intervention
  • On-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu
  • Weekly case conferences
  • Surveys of clinicians and clinical supervisors in accordance with CME curriculum
Other: 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:

  • On-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu
  • Weekly case conferences
  • Surveys of clinicians and clinical supervisors in accordance with CME curriculum




Primary Outcome Measures :
  1. 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.

  2. 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. 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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary Care Provider (MBBS-level physician or Health Assistant)
  • Current staff at healthcare facility in Achham, Bajura, or Doti Districts.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376062


Locations
Nepal
Bayalpata Hospital
Sanfebagar, Achham, Nepal
Charikot Primary Health Center
Bhimeshwor, Dolakha, Nepal
Sponsors and Collaborators
Possible
University of California, San Francisco
Harvard Medical School Center for Global Health Delivery-Dubai
National Institute of Mental Health (NIMH)
Brigham and Women's Hospital
Investigators
Study Director: David Citrin, PhD, MPH Possible

Additional Information:
Responsible Party: Possible
ClinicalTrials.gov Identifier: NCT02376062     History of Changes
Other Study ID Numbers: MHCMEnyaya
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by Possible:
Continuing Medical Education
Chronic Diseases
Nepal
Implementation Research