The purpose of this 3-arm randomized controlled trial 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 study will evaluate a low-intensity digital training program (DGT) compared with traditional face-to-face training (F2F) on change in competence outcomes and cost-effectiveness. This study will also evaluate a high-intensity digital training program with the addition of individualized coaching support (DGT+) compared with traditional F2F on change in competence outcomes and cost-effectiveness.

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.

Inclusion Criteria:

• Adult (age ≥18 years)
• Non-specialist health worker
• Minimum education level 8th Standard
• Willingness to complete training to deliver HAP
• Willingness to stay in the study area during the trial period

Exclusion Criteria:

• Significant speech, sight, or hearing impairment
• Illiterate/ who cannot read and write
• Prior participation in the formative research and pilot testing (during the development of the training programs)

Individual participant data (IPD) from this trial will be shared with the scientific community according to the National Institute of Mental Health (NIMH) Data Archive Data Sharing terms and conditions. Data will have all direct or indirect identifiable information removed before being submitted to the NIMH Data Archive (NDA). After the trial, the investigators will send de-identified information from participants to NDA. Researchers can access this de-identified data by submitting a request to NIMH. Data sharing with NDA offers no direct benefit to participants, though the information provided to NDA may help researchers around the world treat future mental health challenges so that they have better outcomes. Study participants can choose not to have their de-identified data shared with NDA. These details about data sharing with NDA are described in the participant consent form, and additional information is available at the NDA website.

De-identified individual participant data (IPD) will be submitted to the NIMH Data Archive within 12 months after completion of the trial according to the NDA submission schedule and policies.

There is no plan to restrict access to anonymized data for research purposes. However, access will be provided through the NDA Data Access Committee (DAC). Investigators and institutions seeking data from NDA will be expected to meet data security measures and will be asked to submit a Data Use Certification.

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.