CClinicalTrials.gg
Status unknownNCT02376062Updated Dec 6, 2017

Bundled Intervention Integrating Mental Health Services in Nepal

An interventional study of Bundled Intervention in Mental Health, sponsored by Possible. Status unknown at 2 sites in Nepal. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-06.

Sponsored by Possible · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Not applicable
Ages
15 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Mental Health

Keywords

  • Continuing Medical Education
  • Chronic Diseases
  • Nepal
  • Implementation Research
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In context

Lead sponsor

Possible is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • N/A
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
225 participants (estimated)

Study arms

  • 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

Interventions

  • OtherBundled 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

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What researchers measure

Primary outcomes

  1. Changes in knowledge, attitudes, practices, and self-efficacy of Primary Care Providers

    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.

    Time frame: 3 years

  2. Longitudinal clinical outcomes for patients with depression, post-traumatic stress disorder, and patient self-reported medication adherence

    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?".

    Time frame: 3 years

  3. Cost assessment of bundled intervention

    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.

    Time frame: 3 years

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Study locations

2 sites
  • Bayalpata Hospital
    Sanfebagar, Achham, Nepal
  • Charikot Primary Health Center
    Bhimeshwor, Dolakha, Nepal
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02376062
Lead sponsor
Possible
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
Responsible party
Sponsor
First posted
Mar 3, 2015
Start date
Feb 6, 2016
Primary completion
Jul 30, 2019 (estimated)
Completion
Jul 30, 2019 (estimated)
Last update
Dec 6, 2017

Study contacts

David Citrin, PhD, MPH
study director · Possible

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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