IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for DepRESSion (IMPRESS)

Sangath

Status: Enrolling

Conditions: Depression

Treatments: Behavioral: Community Intervention; Behavioral: Healthy Activity Program (HAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05890222

SAN_IMPRESS_2023

Details and patient eligibility

About

The goal of this Hybrid Type 2 Implementation-Effectiveness Cluster Randomised Controlled Trial is to reduce the treatment gap for depression through the integrated implementation of interventions in facility and community platforms, in Goa, India. The primary question is to examine whether a community intervention ("Community Model") enhances the demand for, and improves the outcomes of, an evidence-based, brief psychological treatment for depression delivered by non-specialist health workers in primary health care facilities ("Facility Model"). Participants in the Facility Model arm will receive only a psychosocial intervention for depression (the Healthy Activity Program - HAP) while participants in the Community Model will receive both the HAP and the community intervention. We will compare the Facility Model and the Community Model to assess if the latter is superior in increasing the demand for depression treatment in primary care, increasing uptake of treatment by people with depression, increasing treatment completion rates, and reducing the severity of depression.

Enrollment: 784 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

(A) Contact Coverage Outcome

Inclusion Criteria

• Adults (>18 years)
• Residing in the clusters included in the trial
• Speak English or one of the local languages (Konkani, Marathi, Hindi)

Exclusion Criteria

• Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
• Patients who present to the health centre for emergency medical attention
• Patients with active psychotic symptoms

(B) Effectiveness Coverage Outcome

Inclusion Criteria

• Adults (>18 years);
• Residing in the clusters included in the trial
• Speak English or one of the local languages (Konkani, Marathi, Hindi).
• Screen positive for moderately severe or severe depression (total score >14) on the Patient Health Questionnaire-9 items (PHQ-9)

Exclusion Criteria

• Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
• Patients who present to the health centre for emergency medical attention
• Patients with active psychotic symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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784 participants in 2 patient groups

Community Model

Experimental group

Description:

In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.

Treatment:

Behavioral: Healthy Activity Program (HAP)

Behavioral: Community Intervention

Facility Model

Active Comparator group

Description:

The HAP, a manualized and evidence-based psychological treatment based on behavioural activation, will be delivered by existing healthcare workers (called counsellors from here onwards) within the health centres who will be trained to deliver the HAP.

Treatment:

Behavioral: Healthy Activity Program (HAP)