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Recruiting Not applicable NCT05890222

IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion

No applicable phase (e.g. observational)
Conditions: Depression

Sponsor: Sangath

trial.available_in: БГ
Overview
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.
Who can participate
(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
Interventions
Community Intervention
BEHAVIORAL
Healthy Activity Program (HAP)
BEHAVIORAL
Locations 1
India (1)
Sangath
Mormugao , Goa
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.11.2023
Completion date
30.04.2026
Registry ID
NCT05890222
Source
clinicaltrials.gov
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