Clinical trial NCT05264792: Remote Coaching for Supporting the Implementation of Depression Care in Primary Care in Rural India
Official title: Remote Coaching for Supporting the Implementation of Treatment for Depression in Primary Care Facilities in Madhya Pradesh, India: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder
Psychological
Noncommunicable Diseases
Keywords: primary care
depression
mental health
implementation
hybrid trial
implementation support strategy
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: Sangath
name: Ministry of Health & Family Welfare, India
First posted: 2022-03-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SCREENING

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.

Detailed description: Evidence-based clinical interventions exist for depression; however, the gap between those who need treatment and those who receive it (i.e., the care gap) is alarming, with upwards of 90% of individuals not having access to care in India. Integrating evidence-based treatments into primary care is essential for ensuring access to mental health services, and ultimately, bridging the care gap. In India, many of these barriers to implementation have emerged from prior efforts to integrate evidence-based depression care into primary care, such as suboptimal organization and planning, and demands for training of staff on evidence-based interventions.

Implementation research seeks to improve the integration of evidence-based treatments into routine practice through the use of "Implementation Strategies". In a recent review by Wagenaar et al (2020) on implementation strategies for depression care in low- and middle-income countries, it was found that approximately half of these studies were focused on testing revised professional roles, or task-shifting, for depression intervention implementation. In this review, six studies from India examined the integration, acceptability, feasibility and cost of integrating depression care in routine primary care settings, but only one of these studies had a randomized controlled trial design. There is a need to conduct studies with pragmatic designs to examine the effectiveness and cost-effectiveness of integrating evidence-based depression interventions into routine primary care. Moreover, the reviewed studies have scarcely reported on 'adoption' and initial implementation of depression interventions.

This trial aims to address the treatment gap and the structural and contextual factors affecting the optimal implementation of a collaborative care package for depression in primary care settings in Madhya Pradesh, India. Specifically, this study will employ a cluster-randomized controlled design to evaluate whether a 'remote coaching implementation support strategy' compared to 'routine implementation support' can increase rates of screening for depression (i.e., primary implementation outcome). The trial will also assess the successful implementation of the collaborative depression care package via facility-level indicators, including the following secondary implementation outcomes: 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, including the proportion of patients who achieve remission (defined as PHQ-9\<5) at 3-month follow up, given that this reflects a clinically meaningful treatment target. Additional patient-level outcomes include symptoms of anxiety and functioning.

The trial will explore health facility 'readiness' and its relationship with the adoption of the depression care package. Importantly, this trial will employ the routine health facility cadres, such as the auxiliary nurse midwife (ANM) and nurses, primarily for depression screening, and the medical officer (MO) for diagnosis, treatment and referral of cases, and employ routine data collection and management systems. This trial builds on recent health system-level changes in India where screening and management of non-communicable disorders has already been integrated into primary care, creating a template for the integration of evidence-based depression care.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of proportions of persons screened for depression (using PHQ-2) between arms
timeFrame: Baseline to 9-month follow-up
Secondary outcomes:
measure: Comparison of number of persons who screen positive for depression on the PHQ-2 (i.e., score ≥3) between arms
timeFrame: Baseline to 9-month follow-up
measure: Comparison of number of patients with depression (i.e., PHQ-2 score ≥3) who are referred to the Medical Officer (MO) between arms
timeFrame: Baseline to 9-month follow-up
measure: Comparison of number of patients with depression who initiate evidence-based treatment between arms
timeFrame: Baseline to 9-month follow-up
measure: Comparison of number of patients with depression who complete treatment between arms
timeFrame: Baseline to 9-month follow-up
measure: Comparison of proportions of patients who achieve remission (PHQ-9<5)
timeFrame: Baseline and 3-month follow-up
measure: Patient Severity of Anxiety assessed with the GAD-7
timeFrame: Baseline and 3-month follow-up
measure: Patient Functional outcomes assessed with the WHODAS 2.0
timeFrame: Baseline and 3-month follow-up
Other outcomes:
Locations:
city: Bhopal
country: India
facility: Sangath
state: Madhya Pradesh
Study officials:
affiliation: Sangath
name: Deepak Tugnawat
role: STUDY_DIRECTOR
affiliation: Sangath
name: Anant Bhan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.