Clinical trial NCT04157816: Digital Training for Non-Specialist Health Workers to Deliver a Brief Psychological Treatment for Depression
Official title: Digital Compared to Conventional Training for Non-Specialist Health Workers to Deliver a Brief Psychological Treatment for Depression in Primary Care in India: A Three-Arm Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Mental Disorder
Psychological
Keywords: health worker training
non-specialist health worker
community health worker
task sharing
common mental disorders
low-resource setting
primary care
global mental health
digital technology
mobile health
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: Sangath
First posted: 2019-11-08
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Competency
timeFrame: Change from Baseline to up to 8 weeks.
Secondary outcomes:
measure: Change in Mental Health Knowledge, Attitude, and Behavior
timeFrame: Change from Baseline to up to 8 weeks.
Other outcomes:
measure: Costs Incurred During Participation in the Training Program
timeFrame: Up to 8 weeks.
measure: Satisfaction with the Training Program
timeFrame: Up to 8 weeks.
Locations:
city: Bhopal
country: India
facility: Sangath
state: Madhya Pradesh
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Vikram Patel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel V, Weobong B, Weiss HA, Anand A, Bhat B, Katti B, Dimidjian S, Araya R, Hollon SD, King M, Vijayakumar L, Park AL, McDaid D, Wilson T, Velleman R, Kirkwood BR, Fairburn CG. The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial. Lancet. 2017 Jan 14;389(10065):176-185. doi: 10.1016/S0140-6736(16)31589-6. Epub 2016 Dec 15.
citation: Muke SS, Shrivastava RD, Mitchell L, Khan A, Murhar V, Tugnawat D, Shidhaye R, Patel V, Naslund JA. Acceptability and feasibility of digital technology for training community health workers to deliver brief psychological treatment for depression in rural India. Asian J Psychiatr. 2019 Oct;45:99-106. doi: 10.1016/j.ajp.2019.09.006. Epub 2019 Sep 7.
citation: Muke SS, Tugnawat D, Joshi U, Anand A, Khan A, Shrivastava R, Singh A, Restivo JL, Bhan A, Patel V, Naslund JA. Digital Training for Non-Specialist Health Workers to Deliver a Brief Psychological Treatment for Depression in Primary Care in India: Findings from a Randomized Pilot Study. Int J Environ Res Public Health. 2020 Sep 1;17(17):6368. doi: 10.3390/ijerph17176368.
citation: Naslund JA, Tugnawat D, Anand A, Cooper Z, Dimidjian S, Fairburn CG, Hollon SD, Joshi U, Khan A, Lu C, Mitchell LM, Muke S, Nadkarni A, Ramaswamy R, Restivo JL, Shrivastava R, Singh A, Singla DR, Spiegelman D, Bhan A, Patel V. Digital training for non-specialist health workers to deliver a brief psychological treatment for depression in India: Protocol for a three-arm randomized controlled trial. Contemp Clin Trials. 2021 Mar;102:106267. doi: 10.1016/j.cct.2021.106267. Epub 2021 Jan 6.