Plain English Summary
Background and study aims
Adopting the task-shifting approach where expert knowledge and skills are transferred to lay health workers, the Programme for Improving Mental Health Care (PRIME) trained health workers working at the community health facilities in Chitwan district of Nepal based on the WHO’s mental health Gap Action Programme (mhGAP) Intervention Guidelines. Studies have shown that the provision of services is not enough to minimize the treatment gap in mental health, hence there is a need for increasing demand of mental health services as well. Thus, to bridge this gap, at the community level community sensitization activities were conducted. Similarly, to help with detection and referral of mental health problems, a tool called Community Informant Detection Tool (CIDT) was developed. The CIDT is an instrument that can be used by anyone even with limited education. It consists of a case vignette of particular mental health problem where common symptoms are presented in local idioms accompanied with pictures. In Nepal, the tool is being used by the Female Community Health Volunteers (FCHVs). The CIDT has already been validated and has shown promising results. The aim of this study is to evaluate whether the CIDT is effective at improving help seeking and increasing uptake of mental health services in the health facilities.
Who can participate?
Female Community Health Volunteers (FCHV) working at one of the participating health facilities
What does the study involve?
The health facilities in the PRIME implementation area are randomly allocated to two groups to either use the CIDT or to not use the CIDT. Before the implementation 6 months of data about the total number of identified mental health cases is collected from both groups. The FCHVs associated with all selected health facilities receive a two-day training on home-based care and a general introduction on mental health problems (similar for both groups). Additionally, the FCHVs in the CIDT group are trained about using the CIDT, specifically its concept, process and use in the identification and referral of people with probable mental health problems. After the training, the FCHVs go out in their community and start identifying and referring probable cases of mental health problems to the health facilities. All the referrals made by the FCHVs are recorded in the Health Management Information System (HMIS). At the end of 6 months, HMIS data are collected on the total number of mental health cases identified and treated.
What are the possible benefits and risks of participating?
The possible benefit of participating in the study is increased access to mental health services for people with probable mental health problems. In both groups these benefits are likely to occur, with an increased likelihood of this benefit in the CIDT group. Increased access to services may subsequently lead to improvements in mental health after receiving treatment. Treatment in both groups may temporarily lead to increased levels of anxiety as part of the treatment process.
Where is the study run from?
Transcultural Psychosocial Organization (Nepal)
When is the study starting and how long is it expected to run for?
July 2016 to March 2017
Who is funding the study?
Department for International Development (UK)
Who is the main contact?
Dr Mark Jordans
mark.jordans@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Jordans
ORCID ID
Contact details
TPO Nepal
Baluwatar
Kathmandu
PB602
Nepal
0031619049149
mark.jordans@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1620
Study information
Scientific title
Assessing the effectiveness of the Community Informant Detection Tool (CIDT) in increasing help seeking behavior as measured by Health Management Information System (HMIS)
Acronym
Study hypothesis
CIDT implementing health facilities’ catchment areas (intervention group) have higher number of mental health case referral than health facilities’ catchment areas that do not implement CIDT.
Ethics approval
Nepal Health Research Council, 07/04/2016, protocol no. 1620
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Depression, psychosis, alcohol use disorder and epilepsy
Intervention
Female community health volunteers (FCHVs) from 40 health facilities were randomly assigned (1:1) to:
1. A two-day training on community outreach for mental health services (home based care and community sensitization) was provided to FCHVs covering the catchment area of 40 health facilities. This training dealt with basic concepts of psychosocial, mental health and orientation of 4 mental health problems.
2. The same training on community outreach combined with an additional two days training on detection and referral of four mental health problems using Community Information Detection Tool (CIDT), its concept, and process of use was provided to FCHVs from the intervention group. A monthly supervision was conducted to ensure the quality of work as well as to discuss challenges and possible ways to overcome it.
In both study arms community sensitization was done to make people aware about the availability of mental health services in the health facilities. We assessed the number of mental health cases in each of the study arms as the outcome. FCHVs were blind to condition.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Number of CIDT referral of probable mental health cases recorded in the HMIS over a period of 6 months (i.e. 6 months prior to FCHV training and 6 months following the FCHV training) at the health facilities
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/07/2016
Overall trial end date
30/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Female Community Health Volunteers (FCHV) working in one of the selected health facilities
Participant type
Health professional
Age group
Adult
Gender
Female
Target number of participants
Health facility was the unit of analysis for this study. This study was implemented in 40 health facilities (20 intervention, 20 control). Each health facility has nine FCHV mobilized in the community, hence the total number of participants was 360.
Participant exclusion criteria
FCHVs from health facilities that are not selected in the study
Recruitment start date
13/07/2016
Recruitment end date
16/11/2016
Locations
Countries of recruitment
Nepal
Trial participating centre
Transcultural Psychosocial Organization
Baluwatar
Kathmandu
PB602
Nepal
Funders
Funder type
Charity
Funder name
Department for International Development, UK Government
Alternative name(s)
Department for International Development, DFID
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The trialists are planning to publish the results of the study in a high-impact peer reviewed journal. At present they are aiming to publish their results by November 2018 (or at least submission to the journal) (as a short report) to World Psychiatry or Lancet Global Health. The study is the third on the development and evaluation of the tool, the first two were published in British Journal of Psychiatry and the Bulletin of the World Health Organization. The combination of the three articles will be offered to the World Health Organization for consideration for inclusion in further guidance on integrating mental health into primary health care in low and middle income countries. No additional documents (such as study protocol, statistical analysis plan) are available for this study.
IPD sharing statement
No participant level data will be made available. The dataset will not be made available as it concerns routine health information data from the health facilities where the study was implemented. This data is under the governance of the Nepal Ministry of Health and therefore cannot be made available. The anonymized data will be held by TPO Nepal and will be made available by the corresponding author upon request. Within 1 year after the publication, the dataset will be placed on a secure server that is presently being established.
Intention to publish date
01/09/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list