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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Mental Disorder; Psychological
• Intervention / Treatment: Other: Digital Training; Other: Coaching Support; Other: Face-to-Face Training

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.

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Madhya Pradesh
    • Bhopal, Madhya Pradesh, India, 462016
      • Sangath

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Training (DGT); 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; 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.
Experimental: Digital Training with Coaching Support (DGT+); 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; 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.; Other: Coaching Support; 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).
Active Comparator: Face-to-Face Training; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mental Health Knowledge, Attitude, and Behavior	13-item self-report questionnaire uses a 5-point Likert scale to ascertain non-specialist health workers' knowledge, attitudes, and behavior about different aspects of mental health. Scores range from 13 to 65, with higher scores indicating greater knowledge and better attitudes and behaviors towards persons living with a mental illness. Lower scores on this measure suggest lower levels of knowledge and greater stigma towards mental illness. This is important to measure because completion of the training program may contribute to improvements in knowledge, attitudes and behaviors about mental health. To assess change in mental health knowledge, attitudes, and behavior 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Costs Incurred During Participation in the Training Program	The direct and indirect costs incurred by participants while completing each of the training programs will be collected after completion of the training program at up to 8 weeks. Participants will complete an 8-item questionnaire about the time, travel, and any monetary costs incurred during their completion of the training program. This questionnaire is not scored on a scale; each item will be examined as it relates to specific details about costs related to participation in the training program.	Up to 8 weeks.
Satisfaction with the Training Program	This 26-item questionnaire assesses participants' satisfaction with the training programs (either of the two forms of digital training or the traditional Face-to-Face training). This satisfaction questionnaire will be collected after completion of the training program at up to 8 weeks. Each of the 26-items on the questionnaire is rated on a 6-point Likert scale. The items cover feasibility, acceptability, adoption, and appropriateness of the training program. Scores on this questionnaire range from 26 to 156, with higher scores indicating greater satisfaction with the training program. The purpose of the questionnaire is to identify strengths and weaknesses related to factors and program content that affect participants' motivation and engagement in the training program.	Up to 8 weeks.

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)
• Collaborators: Sangath
• Investigators: Principal Investigator: Vikram Patel, MD, PhD, Harvard Medical School (HMS and HSDM)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): June 20, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: digital technology; mobile health; primary care; community health worker; task sharing; low-resource setting; common mental disorders; global mental health; health worker training; non-specialist health worker
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: U19MH113211-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No