PREMIUM twelve-month follow-up trial: Clinical Outcomes and Cost-effectiveness dataset from the Healthy Activity Program (HAP) RCT

Patel, V, Weobong, B, Bhat, B, McDaid, D and Weiss, H. 2017. PREMIUM twelve-month follow-up trial: Clinical Outcomes and Cost-effectiveness dataset from the Healthy Activity Program (HAP) RCT. [Online]. London School of Hygiene & Tropical Medicine, London, United Kingdom. Available from: https://doi.org/10.17037/DATA.205.

Patel, V, Weobong, B, Bhat, B, McDaid, D and Weiss, H. PREMIUM twelve-month follow-up trial: Clinical Outcomes and Cost-effectiveness dataset from the Healthy Activity Program (HAP) RCT [Internet]. London School of Hygiene & Tropical Medicine; 2017. Available from: https://doi.org/10.17037/DATA.205.

Patel, V, Weobong, B, Bhat, B, McDaid, D and Weiss, H (2017). PREMIUM twelve-month follow-up trial: Clinical Outcomes and Cost-effectiveness dataset from the Healthy Activity Program (HAP) RCT. [Data Collection]. London School of Hygiene & Tropical Medicine, London, United Kingdom. https://doi.org/10.17037/DATA.205.

Description

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 HAP dataset is made available on request, in accordance with ethical constraints outlined in the participant consent agreement. To obtain access, interested parties must complete a data request form or email researchdatamanagement@lshtm.ac.uk outlining the purpose for which they intend to use the dataset and agree to sign a licence agreement confirming that they will protect participant confidentiality.

Methods

Description of data capture

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 capture method

Questionnaire: Fixed form

Data Collection Period

From	To
28 October 2013	30 September 2016

Date (Date submitted to LSHTM repository)

25 July 2017

Geographical area covered (offline during plugin upgrade)

North Latitude	East Longitude	South Latitude	West Longitude
15.634	74.3019	15.3535	74.0025

Language(s) of written materials

English

People & Groups

Data Creators	Patel, V, Weobong, B, Bhat, B, McDaid, D and Weiss, H
LSHTM Faculty/Department	Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Participating Institutions	Harvard Medical School, Boston, United States of America, London School of Hygiene & Tropical Medicine, London, United Kingdom, London School of Economics and Political Science, London, United Kingdom

Projects

Funders

Project	Funder	Grant Number	Funder URI
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	UNSPECIFIED

Additional Information

Date Deposited	26 Jul 2017 09:58
Last Modified	27 Apr 2022 18:20
Publisher	London School of Hygiene & Tropical Medicine

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Data / Code

PREMIUM_Dataset Request access

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Filename: PREMIUM_Dataset.zip

Description: This zip archive contains 3 datasets necessary for the cost-effectiveness,mediation and other analyses

Licence: Data Sharing Agreement

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Documentation

UserGuide_PDF Download

Filename: UserGuide_PDF.pdf

Description: User guide for dataset [PDF]

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File size: 586kB

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UserGuide_TXT Download

Filename: UserGuide_TXT.txt

Description: User guide for dataset [plain text]

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PREMIUM_HAP_InfoSheet_ConsentForm Download

Filename: PREMIUM_HAP_InfoSheet_ConsentForm.pdf

Description: Patient information sheet and consent form used by study - English language

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Content type: Textual content

File size: 373kB

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PREMIUM_Dataset_codebook Download

Filename: PREMIUM_Dataset_codebook.html

Description: Codebook for PREMIUM datasets

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File size: 40kB

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Study Instrument

Beck_Depression_Inventory Download

Filename: Beck_Depression_Inventory.pdf

Description: A 21-item questionnaire assessment of depressive symptoms assessed on a scale of 0 to 3. It measures depression severity based on symptom scores.

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Content type: Textual content

File size: 62kB

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Client_Service_Receipt_Inventory_PtA Download

Filename: Client_Service_Receipt_Inventory_PtA.pdf

Description: Questionnaire used to collect information about the utilisation and costs of health care and lost productivity (including that of care-givers).

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Content type: Textual content

File size: 495kB

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Client_Service_Receipt_Inventory_PtB Download

Filename: Client_Service_Receipt_Inventory_PtB.pdf

Description: Part B of the CSRI was designed for the purposes of the PREMIUM trials to collect data on costs of medication/investigations

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Content type: Textual content

File size: 72kB

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PREMIUM_Abbreviated_Activation_Scale Download

Filename: PREMIUM_Abbreviated_Activation_Scale.pdf

Description: PREMIUM abbreviated activation scale consists of 5 items that measure activation and reinforcement.

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Content type: Textual content

File size: 60kB

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PHQ9_Screening_Questionnaire Download

Filename: PHQ9_Screening_Questionnaire.pdf

Description: 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.

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Content type: Textual content

File size: 63kB

Mime-Type: application/pdf

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PREMIUM_Patient_Intake_Form Download

Filename: PREMIUM_Patient_Intake_Form.pdf

Description: A form designed to collect baseline data.

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Content type: Textual content

File size: 994kB

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PREMIUM_HAP_Therapy_Quality_form Download

Filename: PREMIUM_HAP_Therapy_Quality_form.pdf

Description: A measure designed to assess therapy quality.

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Content type: Textual content

File size: 404kB

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PREMIUM twelve-month follow-up trial: Clinical Outcomes and Cost-effectiveness dataset from the Healthy Activity Program (HAP) RCT

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