NCT05890222

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
784

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 23, 2026

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

May 12, 2023

Last Update Submit

April 22, 2026

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • Contact coverage

    Patient Health Questionnaire 9 items (PHQ-9) score \>4. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.

    During recruitment

  • Effectiveness coverage

    Mean Patient Health Questionnaire 9 items (PHQ-9 score). The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.

    Three months post recruitment

Secondary Outcomes (14)

  • Sustained effectiveness

    Six months post recruitment

  • Remission

    Three months post recruitment

  • Remission

    Six months post recruitment

  • Response to treatment

    Three months post recruitment

  • Response to treatment

    Six months post recruitment

  • +9 more secondary outcomes

Study Arms (2)

Community Model

EXPERIMENTAL

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

Behavioral: Community InterventionBehavioral: Healthy Activity Program (HAP)

Facility Model

ACTIVE COMPARATOR

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.

Behavioral: Healthy Activity Program (HAP)

Interventions

Community InterventionBEHAVIORAL

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.

Community Model
Healthy Activity Program (HAP)BEHAVIORAL

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.

Community ModelFacility Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sangath

Mormugao, Goa, India

RECRUITING

Related Publications (1)

  • Nadkarni A, Gandhi Y, Fernandes L, Mirchandani K, Kamat S, Weiss HA, Singla DR, Velleman R, Lu C, Bhatia U, Biswal B, Sequeira M, D'souza E, Raikar K, Patel V. Effectiveness and cost-effectiveness of a community intervention in enhancing access to care and improving clinical outcomes for depression: a protocol for a cluster randomised controlled trial in India. Trials. 2024 Aug 28;25(1):569. doi: 10.1186/s13063-024-08236-0.

    PMID: 39198915DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2023

First Posted

June 6, 2023

Study Start

November 1, 2023

Primary Completion

November 18, 2025

Study Completion

April 30, 2026

Last Updated

April 23, 2026

Record last verified: 2025-05

Locations

IN(1)