10.17037/DATA.205
The Program for Effective Mental Health Interventions in Under-Resourced Health Systems (PREMIUM) sought to develop and assess scalable psychological treatments that are culturally appropriate, affordable, and feasible for delivery by non-specialist health workers and apply these treatments to the two leading mental health disorders: moderately severe to severe depression (the Healthy Activity Program [HAP]) and harmful drinking (Counselling for Alcohol Problems [CAP]).
This data collection contains records of adult male/female Primary Health Centres (PHC) attenders (one patient per row) recruited in the trials site between October 28th 2013 and July 30th 2015, and followed-up for outcome assessments until September 30th 2016. It encompasses enrolment, treatment process (including therapy quality), cost-effectiveness, and clinical/other outcome data. Only variables relevant for the analysis of our twelve-month follow-up are presented.
The study collected three types of quantitative data - base-line, intervention process, and outcome assessments - at 3 and 12 months. Electronic tablets were used to capture the majority of this data, with the exception of part of the Client Service Receipt Inventory in the Outcome data. This data was uploaded as CSV (Comma Separated Values) files to the GCP-compliant STAR data collection platform (http://opspl.com) operated by the project. Some intervention process data e.g. therapy quality and clinical notes were collected on paper and manually entered into the STAR data collection platform or Microsoft Excel.
Data cleaning was performed in three stages in accordance with strict protocols:
First, range and consistency checks (including verifying participant IDs) were performed on each data source by the data manager at the trial site each week. Issues and queries associated with the dataset were promptly addressed by the trial management team, and an audit trail of performed actions recorded.
Second, the data set was shared with the on-site trials manager (whilst maintaining blinding) who ran their own range, consistency, and missing value checks, and provided feedback to the data manager.
Finally, the cleaned dataset from the trials site was shared with the off-site trials statistician who would run further data cleaning checks, merge values held in separate databases into a single master database, and generate/transform variables for analysis using a STATA .do file.
All analysis (blinded) were conducted based on an a priori TSC/DSMC approved and published analysis protocol. Access to pre-locked data was only granted the data manager and independent statistician.
The data presented here is limited to only key variables used for the twelve-month follow-up analysis.
Primary Health Centres in the north of Goa, a state on the west coast of India.
Range and consistency checks were performed separately for each data source at weekly intervals. Queries identified were resolved promptly by the trial management team, and the database updated to maintain the audit trail.
Human research participants aged between 18 and 65 years.
Ethics approval to conduct the trial was obtained from the Institutional Review Boards at the London School of Hygiene and Tropical Medicine, Sangath (the implementing institution in India), and the Indian Council of Medical Research.
Twelve-month follow-up, general adult depression, economic outcomes, counselling, lay counsellors, Goa, India, RCT.
English.
| Project title | Funder/sponsor | Funder grant ID |
| Sustained effectiveness and cost-effectiveness of the Healthy Activity Program, a brief psychological treatment for depression delivered by lay counsellors in primary care: twelve-month follow-up of a randomised controlled trial | Wellcome Trust | 091834 |
| Forename | Surname | Faculty / Dept | Institution | Role |
| Vikram | Patel | Department of Global Health and Social Medicine | Harvard Medical School, Boston, USA | Contact Person |
| Benedict | Weobong | Faculty of Epidemiology and Population Health | London School of Hygiene and Tropical Medicine | Data Creator/Project Manager |
| Bhargav | Bhat | Data | Sangath, India | Data Creator/Data Manager |
| David | McDaid | Personal Social Services Research Unit | London School of Economics and Political Science | Data Creator/Researcher |
| Helen | Weiss | Faculty of Epidemiology and Population Health. | London School of Hygiene and Tropical Medicine | Data Creator/Trials Statistician |
| Filename | Description | Access status | Licence |
| PREMIUM_HAP_Econ_dataset_3_and_12_months | Dataset containing key variables used for the main effectiveness analysis. This includes: baseline, 3-month outcome, 12-month clinical outcomes and other outcomes variables. This also includes variables used for our mediation analysis, treatment delivery, and serious adverse events. | Request access | Data Sharing Agreement |
| PREMIUM_Repeated_Measures_Mediation_Long | This ‘long’ format data set contains key variables used for the main repeated measures analysis, mediation analysis, and generation of line graphs. | Request access | Data Sharing Agreement |
| PREMIUM_HAP_Econ_dataset_3_and_12_months | Data set contains key variables used for the main cost-effectiveness analysis. This includes: 3 and 12 month intervention health service use costs, out of pocket costs and productivity losses, as well as clinical outcomes used including Quality Adjusted Life Years scores. | Request access | Data Sharing Agreement |
| Beck_Depression_Inventory | A 21-item questionnaire assessment of depressive symptoms assessed on a scale of 0 to 3. It measures depression severity based on symptom scores. | Open | Creative Commons Attribution (CC-BY) |
| Client_Service_Receipt_Inventory_PtA | Questionnaire used to collect information about the utilisation and costs of health care and lost productivity (including that of care-givers). | Open | Creative Commons Attribution (CC-BY) |
| Client_Service_Receipt_Inventory_PtB | Part B of the CSRI was designed for the purposes of the PREMIUM trials to collect data on costs of medication/investigations | Open | Creative Commons Attribution (CC-BY) |
| PHQ9_Screening_Questionnaire | A short 9-item depression assessment tool that is able to detect and provide probable diagnosis of depression as well as a symptom severity score. | Open | Creative Commons Attribution (CC-BY) |
| PREMIUM_Abbreviated_Activation_Scale | PREMIUM abbreviated activation scale consists of 5 items that measure activation and reinforcement. | Open | Creative Commons Attribution (CC-BY) |
| PREMIUM_Patient_Intake_Form | A form designed to collect baseline data. | Open | Creative Commons Attribution (CC-BY) |
| PREMIUM_HAP_Therapy_Quality_form | A measure designed to assess therapy quality. | Open | Creative Commons Attribution (CC-BY) |
| WHO_Disability_Assessment_Schedule | A 12-item questionnaire for measuring functional impairment over the previous 30 days. In addition, two items assess number of days the person was unable to work in the previous 30 days. | Open | Creative Commons Attribution (CC-BY) |
| PREMIUM_dataset_codebook | Twelve month follow-up data codebook organized under: variable name, variable description, value label for each variable, source of variable, and remarks/suggested variable transformation. | Open | CC-BY |
| PREMIUM_HAP_InfoSheet_ConsentForm | Patient information sheet (“What You Need To Know About The Study Of Counselling In Primary Care”) and consent form used by study – English language | Open | CC-BY |