Digital Training for Non-Specialist Health Workers to Deliver a Brief Psychological Treatment for Depression

Last updated on July 2021

Recruitment

Recruitment Status: Active, not recruiting
Estimated Enrollment: 336

Summary

Conditions

Depression
Mental Disorder
Psychological

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study employs a 3-arm parallel randomized controlled trial design. Participants are randomly allocated to one of three training interventions: 1) low-intensity digital training (DGT); 2) high-intensity digital training with additional coaching support (DGT+); and 3) traditional face-to-face training (F2F).Masking: Double (Investigator, Outcomes Assessor)Masking Description: In this trial, the Outcome Assessors administering study assessments at baseline and at endpoint will be masked to the intervention arm that participants are allocated to receive. The Study Investigators will also be masked to the intervention arm that participants are allocated to receive. Masking Outcome Assessors and Study Investigators will minimize potential bias due to knowledge of which arm the participant is allocated to, and can ensure unbiased ascertainment of study outcomes is possible. For allocation concealment, the intervention allocation for each participant will not be revealed to the participant until they have been enrolled into the trial, to avoid selection bias.Primary Purpose: Health Services Research

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

Few individuals living with depression in India have access to adequate treatment in primary care settings. Task-sharing, which involves building capacity of frontline non-specialist health workers to deliver evidence-based treatment for common mental disorders such as depression, is an effective approach for bridging these gaps in available care. This emphasizes the need for novel approaches to scale up training efforts and to support the development of a skilled and competent workforce capable of delivering high quality treatment for depression in primary care settings. Therefore, the purpose of this study is to compare two forms of digital training (i.e., low-intensity and high-intensity) with traditional face-to-face training of non-specialist health workers to deliver an evidence-based brief psychological treatment for depression called the Healthy Activity Program (HAP) in primary care settings in India. This trial uses a 3-arm randomized controlled design. This study will evaluate a low-intensity digital training (DGT) compared with traditional face-to-face training (F2F) on change in competence outcomes and cost-effectiveness; and evaluate a high-intensity digital training with the addition of individualized coaching support (DGT+) compared with traditional F2F on change in competence outcomes and cost-effectiveness. In this trial, a total of 336 non-specialist health workers will be recruited from community health centers in Sehore District of Madhya Pradesh, a large and predominantly rural state situated in central India. This trial will generate knowledge on the most effective and cost-effective approaches to address the critical knowledge gap regarding the training of non-specialist health workers to deliver an evidence-based brief psychological treatment for depression in a low-resource setting. The findings from this trial will inform broader efforts to develop a mental health workforce necessary for scaling up brief psychological therapies for common mental disorders.

Tracking Information

NCT #: NCT04157816
Collaborators: Sangath
Investigators: Principal Investigator: Vikram Patel, MD, PhD Harvard Medical School