Remote Coaching for Supporting the Implementation of Depression Care in Primary Care in Rural India

NCT05264792 | Completed

• 2 other identifiers: U19MH113211-ITU19MH113211
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This cluster-randomized hybrid type-II implementation superiority trial will include 14 rural primary care facilities in Madhya Pradesh, which will implement a collaborative depression care packaged based on the WHO mhGAP program. These 14 facilities will be randomized to receive either 'Enhanced Implementation Support' or the existing 'Routine Implementation Support' control condition to determine if Enhanced Implementation Support is superior to Routine Implementation Support for ensuring successful implementation of the depression care package. Enhanced Implementation Support consists of remote coaching support and technical assistance. The primary implementation outcome is the proportion of outpatients screened on the PHQ-2 by facility staff. Secondary implementation outcomes will also be collected, including the number of depression cases identified, number of patients with depression referred to the medical officer, number of patients referred to an accepted treatment intervention (i.e., either antidepressant medication or brief psychological intervention), and number of patients who successfully complete treatment at follow up. Secondary patient outcomes will also be collected from patients enrolled in each arm. Patient-level outcomes include the proportion of patients who achieve remission (defined as PHQ-9\<5) at 3-month follow up. Additional patient-level outcomes include symptoms of anxiety and functioning. This trial will develop and test an Enhanced Implementation Support strategy for integrating evidence-based mental health services into primary care facilities. Findings from the trial will inform the need to have external coaching for primary care facilities to meet their depression screening and treatment goals, or if they can achieve these goals via routine system support. This is crucial to inform policymakers, due to severe constraints on mental health budgets for programs in India. Findings can generate insights to inform the scale-up of depression care across other districts in Madhya Pradesh and in India.

Conditions

Depression; Depressive Disorder; Psychological; Noncommunicable Diseases

Keywords

primary care; depression; mental health; implementation; hybrid trial; implementation support strategy

Outcome Measures

Primary Outcomes (1)

• Comparison of proportions of persons screened for depression (using PHQ-2) between arms

  For the primary implementation outcome, the proportions of outpatients screened on the PHQ-2 by the ANM/nurse will be compared between the study arms. The 2-item Patient Health Questionnaire (PHQ-2) is a widely used brief tool for screening for depression in primary care settings. Scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). A score of 3 or greater is considered indicative of depressive symptoms. The screenings proportion will be estimated out of the total adult population attending the general outpatient clinics of primary health centers during the trial period. ANMs/nurses will use a Screening Record Register to document the number of patients screened within each facility.

  Baseline to 9-month follow-up

Secondary Outcomes (7)

• Comparison of number of persons who screen positive for depression on the PHQ-2 (i.e., score ≥3) between arms

  Baseline to 9-month follow-up

• Comparison of number of patients with depression (i.e., PHQ-2 score ≥3) who are referred to the Medical Officer (MO) between arms

  Baseline to 9-month follow-up

• Comparison of number of patients with depression who initiate evidence-based treatment between arms

  Baseline to 9-month follow-up

• Comparison of number of patients with depression who complete treatment between arms

  Baseline to 9-month follow-up

• Comparison of proportions of patients who achieve remission (PHQ-9<5)

  Baseline and 3-month follow-up

Study Arms (2)

Routine Implementation Support

ACTIVE COMPARATOR

All 14 health facilities will continue to receive existing routine implementation support. The facilities allocated to the control arm (n=7) will receive routine implementation support only.

Other: Routine Implementation Support

Enhanced Implementation Support

EXPERIMENTAL

In addition to routine support, Enhanced Implementation Support will be provided to 7 facilities allocated to the 'intervention arm'.

Other: Enhanced Implementation Support; Other: Routine Implementation Support

Interventions

Enhanced Implementation Support OTHER

This support package will include: 1. one-on-one remote (phone/web-based) technical assistance sessions (every two weeks) between the facility team and the study team Implementation Support Coaches. These sessions will involve a discussion on successes and challenges in integrating depression screening with routine care and developing strategies to improve screening, using the PDSA (Plan Do Study Act) cycle model. 2. remote peer learning community (peers include ANMs and Nurses who administer screening) through a cross-facility WhatsApp group moderated by the study team Coaching Support Team. 3. virtual peer learning network conferences (quarterly) moderated by the Coaching Support Team focused on lessons learned in improving depression screening. The 9-month intervention duration is informed by the Institute of Healthcare Improvement's Breakthrough Series guidelines.

Enhanced Implementation Support

Routine Implementation Support OTHER

This support package will include weekly meetings between District and facility teams, to review and discuss mental health performance indicators, such as depression screening rate, refusal rate for PHQ-2 screening, proportion of referrals of screened positive patients from auxiliary nurse midwife (ANM) to Medical Officer, and rates of diagnosis and initiation of treatment of depression. These indicators will be collated and reviewed by the district team as part of existing non-communicable disease (NCD) care indicators. Monthly performance data will be then emailed by the district team to the facilities, in addition to further data submission reminders. Note that these weekly interactions between the district and facility teams does not include the additional PDSA cycle-based coaching support.

Enhanced Implementation Support; Routine Implementation Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Facilities must be primary health centers in Sehore district, Madhya Pradesh, which have been upgraded to "Health and Wellness Center" status offering services for non-communicable disease care, and that have an Accredited Social Health Activist (ASHA) worker linked to the Health and Wellness Center to ensure access to the brief psychological treatment for depression
• Patients must be outpatients seen at these facilities, and must be adults of any gender age ≥18 years
• Patients must screen positive for depression by the ANM/nurse defined as having a PHQ-2 score ≥3.

You may not qualify if:

• Facilities that have not been upgraded to Health and Wellness Center and that do not have a linked ASHA worker
• Patients that have significant speech, hearing, language or cognitive impairment impacting their ability to provide informed consent and complete study assessments
• Patients in need of urgent medical or psychiatric attention (e.g., emergency treatment or in-patient admission)
• Patients who do not plan to stay in the study catchment area for at least three months at the time of consent
• Patients who do not understand Hindi

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• Sangath: collaborator
• Ministry of Health & Family Welfare, India: collaborator

Study Sites (1)

Sangath

Bhopal, Madhya Pradesh, 462016, India

Location

Related Publications (2)

• Bondre AP, Singh A, Tugnawat D, Chandke D, Khan A, Shrivastava R, Lu C, Ramaswamy R, Patel V, Bhan A, Naslund JA. Remote coaching for supporting the implementation of treatment for depression in primary care in Madhya Pradesh, India: protocol for a cluster randomized controlled trial. Front Health Serv. 2024 Sep 24;4:1477444. doi: 10.3389/frhs.2024.1477444. eCollection 2024.

  PMID: 39381591 BACKGROUND

• Tugnawat D, Singh A, Anand A, Bondre A, Chandke D, Dhurve P, Joshi U, Khan A, Muke S, Negi B, Nikhare K, Rathore D, Ramaswamy R, Haney JR, Sen Y, Sharma K, Shrivastava R, Verma N, Vishwakarma R, Vishwakarma D, Vorapanya V, Patel V, Bhan A, Naslund JA. ESSENCE: An Implementation Research Program to Scale Up Depression Care in Rural Communities. Psychiatr Serv. 2024 Feb 1;75(2):167-177. doi: 10.1176/appi.ps.202100223. Epub 2023 Oct 31.

  PMID: 37904491 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder; Noncommunicable Diseases; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Deepak Tugnawat

  Sangath

  STUDY DIRECTOR

• Anant Bhan, MD

  Sangath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is not possible to mask collection of implementation outcomes at the facility level or to blind the primary health center staff to arm allocation. For patient-level outcomes, outcome assessors and investigators will be masked. Patients who enroll in the study will not be informed about the allocation of their respective facility; therefore, it is unlikely that they would become aware of arm allocation. The study outcome assessors will be blinded to arm allocation of the participants' facilities, and the patient outcome assessments will be conducted at the patient's home or a mutually agreed location, other than the facility. The study team will also ensure separation between the Support Coaching Team delivering the Enhanced Implementation Support strategy and the outcome assessors to avoid any communication that could indicate the arm allocation of participants and facilities. The statistician who will analyze the final outcome data will also be blinded to arm allocation.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Global Health and Social Medicine

Model Details: This study employs a 2-arm parallel cluster-randomized controlled trial design, where the cluster is defined as the Primary Health Centre-Health and Wellness Centre (PHC-HWC). Clusters (14 PHCs-HWCs) are randomly allocated to one of the two implementation support strategies: 1) Routine (existing) implementation support as provided by District Program Management (DPM) team to the facilities (control condition); 2) Enhanced Implementation support consisting of remote coaching provided by the study team in addition to aforementioned Routine Support (intervention condition).

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: March 3, 2022
• Study Start: October 6, 2022
• Primary Completion: October 5, 2023
• Study Completion: December 31, 2023
• Last Updated: October 18, 2024

Record last verified: 2024-10

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)