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

NCT04157816 | Completed DMC

• 1 other identifier: U19MH113211-03
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Competency

  26-item multiple choice exam to assess the competency of the non-specialist health workers in delivering the Healthy Activity Program (HAP) after training. The measure consists of clinical vignettes followed by multiple-choice questions focused predominantly on assessing applied knowledge. Scores on the measure range from 0 to 26, with higher scores indicating higher levels of competency for delivering HAP. There are three different equivalent versions of this 26-item measure, and each participant will be assessed randomly with one of these at each of the two time points, ensuring that the same test is not used twice.To assess change in competency between two time points, this measure will be collected at baseline and at up to 8 weeks.

  Change from Baseline to up to 8 weeks.

Secondary Outcomes (1)

• Change in Mental Health Knowledge, Attitude, and Behavior

  Change from Baseline to up to 8 weeks.

Other Outcomes (2)

• Costs Incurred During Participation in the Training Program

  Up to 8 weeks.

• Satisfaction with the Training Program

  Up to 8 weeks.

Study Arms (3)

Digital Training (DGT)

EXPERIMENTAL

Participants allocated to this arm receive a low-intensity digital program accessible by smart phone app for training 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.

Other: Digital Training

Digital Training with Coaching Support (DGT+)

EXPERIMENTAL

Participants allocated to this arm receive a high-intensity digital program accessible by smart phone app augmented with weekly telephone coaching support for training 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.

Other: Digital Training; Other: Coaching Support

Face-to-Face Training

ACTIVE COMPARATOR

Participants allocated to this arm receive a traditional classroom-based (face-to-face) program hosted in community settings for training 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.

Other: Face-to-Face Training

Interventions

Face-to-Face Training OTHER

This intervention is a traditional classroom-based (face-to-face) training program for non-specialist health workers offering instruction for the delivery of the Healthy Activity Program (HAP) in primary care settings. HAP is an evidence-based brief psychological treatment for depression. The classroom instruction follows the HAP manuals and is facilitated by an experienced counselor with certification as a Master Trainer, meaning that they have significant experience delivering HAP to patients with depression in clinical settings and also training other health workers in the delivery HAP. The total duration of classroom instruction is 6 days.

Face-to-Face Training

Digital Training OTHER

This 4-week digital training program for non-specialist health workers is accessed through a smart phone app and offers instruction in the delivery of the Healthy Activity Program (HAP) in primary care settings. HAP is an evidence-based brief psychological treatment for depression. The digital training covers the same content as the Face-to-Face training. The course includes 16 modules with video lectures, role-play videos, graphics, slide presentations, quizzes, and assessment questions. Participants also receive low-intensity support to enhance their learning experience and sustain engagement, including: 1) access to an automated 'Help Line' that participants can call any time with questions about the program; 2) weekly automated messages sent through the mobile app to encourage participants; and 3) automated messages and phone calls to participants who show prolonged periods of inactivity in the mobile app to offer technical support and help them complete the training program.

Digital Training (DGT); Digital Training with Coaching Support (DGT+)

Coaching Support OTHER

Individualized remote coaching is a form of high-intensity support that will be used to help sustain participant engagement in the digital training program and promote success in progressing through the course. Each week, a Coach will phone participants and offer encouragement and support related to the course. The phone call will last no more than 60 minutes. The Coach will be someone who has successfully completed the course, and therefore can offer first hand knowledge of the content. During the coaching session, the coach will review the participants' progress through the course, offer praise and encouragement, discuss any challenges or questions related to the course content, and review the participants' goals and plans for the upcoming week. Each participant will receive a maximum of 4 remote coaching sessions (1 per week over the 4-week training program).

Digital Training with Coaching Support (DGT+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• Sangath: collaborator

Study Sites (1)

Sangath

Bhopal, Madhya Pradesh, 462016, India

Location

Related Publications (5)

• 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.

  PMID: 27988143 BACKGROUND

• 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.

  PMID: 31557716 BACKGROUND

• 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.

  PMID: 32883018 BACKGROUND

• 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.

  PMID: 33421650 BACKGROUND

• Joshi U, Haney JR, Sequeira M, Singla DR, Patel V, Bhan A, Cooper Z, Naslund JA. Adaptation and translation of a scalable measure for assessing health worker competence to deliver a brief psychological intervention: A case study from central India of its comparison to a performance-based measure. Psychiatr Q. 2023 Mar;94(1):33-47. doi: 10.1007/s11126-022-10007-6. Epub 2022 Dec 20.

  PMID: 36536268 DERIVED

MeSH Terms

Conditions

Depression; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Vikram Patel, MD, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Global Health and Social Medicine

Model Details: 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).

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 8, 2019
• Study Start: November 20, 2019
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 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.
• Access Criteria: 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.

Locations

IN (1)