RecruitingNot ApplicableNCT05890222

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

Sponsor

Sangath

Enrollment

784 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Depression

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

(A) Contact Coverage Outcome
Adults (\>18 years)
Residing in the clusters included in the trial
Speak English or one of the local languages (Konkani, Marathi, Hindi)
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 Criteria7

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
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

BEHAVIORALCommunity Intervention

Community intervention strategies will be delivered by community volunteers (called Sangathis - which means companion in Konkani, one of the local languages) to i) enhance demand for the HAP treatment and ii) promote engagement with, and completion of, the HAP treatment. The community intervention is co-produced with local community members and includes strategies such as activities to increase awareness about depression (community meetings, street plays and health camps), and dissemination of psycho-educational materials (i.e., leaflets and posters), identify people with possible depression in the community, and facilitate access to HAP in the health centres. Additionally, the Sangathis will coordinate continuing care of people receiving HAP, through home visits to encourage behavioural activation, homework completion and following up with the counsellor, and engaging family members to support the patient in achieving treatment goals.

BEHAVIORALHealthy Activity Program (HAP)

HAP includes the following strategies: psychoeducation, behavioural assessment, activity monitoring, activity structuring and scheduling, activation of social networks, and problem-solving. HAP will be delivered in an individual format. It entails three phases of treatment, delivered over six to eight sessions, each lasting up to 40 minutes, with the sessions being at weekly intervals. Sessions will be delivered face-to-face, at the health centre where the counsellors already work.