Data for Thinking Healthy Programme India trial (THPP-India)

Data Description

An anonymised dataset of 280 women (one row per woman) who gave informed consent to participate in an individually-randomised, parallel, superiority, controlled trial in Goa, India in 2014-2016. The intervention was an adapted version of the Thinking Healthy Programme, delivered by peers; the control was enhanced usual care. Further details are available in the published protocol and paper. The dataset contains records of variables on stratified randomisation, socio-demographic information, depression and related outcomes, and therapy adherence. Visits occurred at baseline, and 3 and 6 months post-natal.

Data Collection Methods

Ethel D’Souza (Sangath) oversaw the day-to-day data management of the project.

Two modes of data collection were used in the trial:

1. Paper based data capture using paper case report forms (pCRF).
2. Electronic data capture using electronic case report forms (eCRF) on tablets.

Baseline data were collected using eCRFs which had pre-programmed check rules; the only exception to this data collection method was the record of intake form which used to collect address details of the patient (pCRF).

Intervention process indicator data were collected on paper.

Outcome evaluation data were collected using eCRFs which had pre-programmed check rules; the only exception was part B of the CSRI which was in paper form.

Therapy Quality data were collected using the therapy quality paper forms.

Data Analysis and Preparation

Data received from the field site were checked by the data team member responsible for data checks to identify any transfer problems. Computerised and manual checks were performed at data acquisition, entry or management stage. Complete documentation of errors was maintained in an error log file (MS Excel file) and reported to the appropriate person for resolution. Self-evident corrections were made by the data team and recorded in the audit log. Irresolvable queries were raised with the data collectors (ERA, PV, IF) via telephone or in a weekly meeting and appropriate responses recorded in the log. The error log file was closely monitored to identify the type and pattern of errors and was used for re-training the data collectors if necessary.

The final checks were carried out by Fiona Vanobberghen and Helen Weiss (statisticians, LSHTM), who were responsible for the data analysis, following the statistical analysis plan which was finalised on 23 August 2017. Statistical analyses were conducted in Stata version 14 (StataCorp, TX, USA).

Geographic regions

North Goa, India.

Key dates

The first and last baseline interviews (among enrolled women) were on 24 October 2014 and 22 June 2016, respectively. The blinded results were presented to the trial steering committee in October 2017, followed by unblinding. The final version of the data from site was produced in February 2018, and from the statistician (after cleaning, processing, etc) in June 2018.

Quality Controls

Range and consistency checks were performed. Queries identified were resolved promptly by the study team, and the database updated.

Species:

Human population.

Pregnant women aged ≥18 years with moderate-severe depression (score ≥10 on the Patient Health Questionnaire 9, PHQ-9).

Privacy:

All data containing personal identifiers of participants have been delinked. All data will be archived for as long as specified by regulations, funding body and/or sponsor. Personal data (such as patient addresses) collected on the patient intake form at baseline are safely stored in a locked cupboard at the trial office. All electronic data are stored on the Sangath Server with controlled access for authorised staff only.

Ethics

Ethical approval was obtained from the Institutional Review Boards at the London School of Hygiene & Tropical Medicine, Sangath (the implementing institution in India), and the Indian Council of Medical Research.

Keywords

Perinatal depression; cognitive behavioural therapy; Thinking Healthy Programme.

Language of written material

English.

Project title

South Asian Hub for Advocacy, Research and Education in mental health (SHARE) Thinking Healthy Programme –  Peer-delivered (THPP-India).

Funder/Sponsor

National Institute for Mental Health.

Grant Number

U19MH095687-01.

Additional Information

Registered on ClinicalTrials.gov, registry number NCT02104232.

Data Creators

File Description