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

Data Description

An anonymised dataset of 570 women (one row per woman) who gave informed consent to participate in a cluster randomised, parallel, superiority, controlled trial in Rawalpindi, Pakistan in 2014-2017. 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 and clusters, socio-demographic information, depression and related outcomes, and therapy adherence. Visits occurred at baseline, and 3 and 6 months post-natal.

Data Collection Methods

Ahmed Zaidi, Software Engineer with specialization in Project Management (Human Research Development (HDR) Foundation) oversaw the day-to-day data management of the project.

The questionnaires were designed by the research team with the help of trial manager and site PI. These questionnaires were developed by the Data Manager (Ahmed Zaidi) using Open Data Kit (ODK) with all the skips and logics according to the requirement. The electronic forms were added into the tablets which were given to the research assessment team. The assessors asked the questionnaires from the respondents (Trial Participants) and filled the forms on the tablets and after completing the questionnaire, sent the forms directly from the field to the database server with the help of the internet. The data was kept in the PostgreSQL database in which different queries were designed to help ensure the data completeness.

The data manager (Ahmed Zaidi) kept a check on the forms that came daily on to the server. He used to run different consistency and analytical checks on the data on weekly basis and also kept a record for all the missing forms with their status mentioned. The data reports were generated on weekly basis and feedback was given to the assessors on all the data related issues. These issues were addressed and the data manager made sure that the mistakes are not repeated again during the collection phase.

The follow up lists were generated using the Date of Births (DOBs) given by the Lady Heath Workers (LHWs) and these lists were accurately made with the help of different queries and were distributed to the field coordinators who arranged follow up interviews on timely basis. The whole procedure was supervised by the data manager who kept careful log of the dates of follow ups to make sure that the follow up interviews are conducted within the window period.

Qualitative data were collected using in-depth interviews among selected Trial Participants. These interviews were collected on paper manually by our intervention facilitators and were supervised by clinical coordinator (Ikhlaq Ahmad). These data are not included in the depository.

Data Analysis and Preparation

Data cleaning and preparation was done in three stages. At the first stage, the data manager ensured that the missing forms were handled and the reason of their missing was mentioned in the status section.

At second stage, the data was cleaned and every change in the database was added in the audit table. Proper cleaning exercise was conducted, all the outliers were handled properly, duplicate forms were discarded, any form with missing values were also handled.

At the final stage, the data was shared with the trial statistician by the data manager. 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

Rawalpindi, Pakistan.

Key dates

The first and last baseline interviews (among enrolled women) were on 15 October 2014 and 8 March 2017, 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 September 2017, 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:

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. In instances where it is necessary to keep these identifiers linked to the participant’s data, we have kept these securely in the local database server protected by the data manager and the hard copies are present at the site in the locked cupboard, only accessible to the data manager.

Ethics

Ethical approval was obtained from the Institutional Review Boards at LSHTM, the University of Liverpool, and the Human Development Research Foundation (the trial implementing institution in Pakistan).

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-Pakistan).

Funder/Sponsor

Supported by the National Institute for Mental Health.

Grant Number

U19MH095687-01

Additional Information

Registered on ClinicalTrials.gov, registry number NCT02111915.

Data Creators

File Description