Condition category
Mental and Behavioural Disorders
Date applied
18/05/2018
Date assigned
23/05/2018
Last edited
23/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

TPO Nepal

Sponsor details

Baluwatar
Kathmandu
PB602
Nepal

Sponsor type

Research organisation

Website

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

01/11/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes