Mental HealthNCT02376062
Bundled Intervention Integrating Mental Health Services in Nepal
A study testing Bundled Intervention in people with Mental Health, run by Possible at 2 sites in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Bundled Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesNepal
- Study dates
- 6 Feb 2016to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary Care Provider (MBBS-level physician or Health Assistant)
- Current staff at healthcare facility in Achham, Bajura, or Doti Districts.
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
Nepal2 sites
Charikot Primary Health Center
Bhimeshwor, Dolakha
Bayalpata Hospital
Sanfebagar, Achham
About this study
Official title: 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.
- Conditions
- Mental Health
- Being tested
- Bundled Intervention
- Keywords
- Continuing Medical Education, Chronic Diseases, Nepal, Implementation Research
- Medical subject headings
- Psychological Well-Being, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundled InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Bundled Intervention | Experimental | * 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 Receives: Other: Bundled Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
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?".
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start6 Feb 2016
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Possible
- Sponsor type
- University, hospital or other
- 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
- Investigators
- David Citrin, PhD, MPH, Study director, Possible
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376062
- Sponsor's protocol ID
- MHCMEnyaya
- Status last verified
- Dec 2017
- First submitted
- 31 Dec 2014
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bundled Intervention Integrating Mental Health Service Into Rural Primary Care in Nepal: Implementation Research Study
- ClinicalTrials.gov ID
- NCT02376062
- Acronym / sponsor ID
- MHCMEnyaya
- Conditions
- Mental Health
- Keywords
- Continuing Medical Education, Chronic Diseases, Nepal, Implementation Research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- PossibleUniversity, hospital or other
- 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
- Study start
- 6 Feb 2016 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bundled Intervention | Experimental | Other: 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Primary Care Provider (MBBS-level physician or Health Assistant)
- Current staff at healthcare facility in Achham, Bajura, or Doti Districts.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bundled InterventionThe 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 | Other | Bundled Intervention |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- PossibleLink provided by the sponsor.
- Healthcare Systems Design GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Citrin, PhD, MPH study director
Possible
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundled Intervention in people with Mental Health, run by Possible at 2 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in knowledge, attitudes, practices, and self-efficacy of Primary Care Providers (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.