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
|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|
Experimental: Bundled Intervention
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:
- 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.
- 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?".
- 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.
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
|Sanfebagar, Achham, Nepal|
|Charikot Primary Health Center|
|Bhimeshwor, Dolakha, Nepal|
|Study Director:||David Citrin, PhD, MPH||Possible|