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

June 29, 2026 updated by: Sangath
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
816

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Goa
      • Mormugao, Goa, India
        • Sangath

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

(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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Community Model
In addition to the facility model, village clusters in this arm will receive community intervention strategies delivered by community volunteers.
Behavioral: Community 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.
Behavioral: Healthy 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.
Active Comparator: Facility Model
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness coverage
Time Frame: Three months post recruitment
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
Contact coverage
Time Frame: During recruitment
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sustained effectiveness
Time Frame: Six months post recruitment
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.
Six months post recruitment
Remission
Time Frame: Three months post recruitment
Patient Health Questionnaire 9 items (PHQ-9 score) score <10. . The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Three months post recruitment
Remission
Time Frame: Six months post recruitment
Patient Health Questionnaire 9 items (PHQ-9 score) score <10. . The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Six months post recruitment
Response to treatment
Time Frame: Three months post recruitment
>50% reduction in Patient Health Questionnaire 9 items (PHQ-9 score) score. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Three months post recruitment
Response to treatment
Time Frame: Six months post recruitment
>50% reduction in Patient Health Questionnaire 9 items (PHQ-9 score) score. The minimum score is 0 and maximum score is 27; with higher scores indicating greater severity of depression.
Six months post recruitment
Treatment completion
Time Frame: Across 12 months of implementation
Met treatment goals or completed the maximum number of sessions or were referred to mental health specialists
Across 12 months of implementation
WHO Disability Assessment Schedule (WHODAS 2.0)
Time Frame: Baseline, 3- and 6- months post recruitment
Standardized disability scores used to estimate Quality Adjusted Life Years (QALYs). The 12-item WHODAS 2.0 score ranges from 12 to 60, where higher scores indicate higher disability or loss of function.
Baseline, 3- and 6- months post recruitment
Inventory form for collecting system-level economic costs of delivering interventions
Time Frame: Monthly, through study completion up to approximately 12 months
System-level costs: Economic costs in WHO six building blocks for delivering the interventions
Monthly, through study completion up to approximately 12 months
Perceived social support
Time Frame: 3- and 6- months post recruitment
Perception of social support received. This will be a bespoke tool developed for our trial and will have questions to assess perceived support related to support provided by community volunteers in our community intervention and higher scores will indicate greater support.
3- and 6- months post recruitment
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Baseline, 3- and 6-months post-recruitment
12 item short instrument designed to measure an individual's perception of support from 3 sources: family, friends and a significant other. Minimum score 12 and maximum 84
Baseline, 3- and 6-months post-recruitment
Behavioral activation
Time Frame: Baseline, 3- and 6- months post recruitment.
Level of behavioral activation measured using PREMIUM Abbreviated Activation Scale. This is a five-item scale, originally developed based on the Behavioural Activation for Depression Scale. It includes five self-reported indicators and the total score can range from 0 to 20. Higher scores indicate greater level of behavioural activation such as engagement with a variety of activities, and associated pleasure and mastery.
Baseline, 3- and 6- months post recruitment.
Client Service Receipt Inventory
Time Frame: 3- and 6- months post recruitment
Out-of-pocket costs for receiving care and the related non-medical costs
3- and 6- months post recruitment
Survey form for collecting costs of receiving HAP intervention to patients
Time Frame: 3 months post recruitment
Out-of-pocket costs for receiving HAP intervention (e.g. time loss, travel)
3 months post recruitment
Depression awareness
Time Frame: Baseline, 6, 12 and 18 months of implementation
Awareness about depression. This will be a bespoke tool developed for our trial and will have questions to assess awareness related to depression based on the information disseminated in our community intervention and higher scores will indicate greater awareness.
Baseline, 6, 12 and 18 months of implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sangath

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Harvard Medical School (HMS and HSDM)
London School of Hygiene and Tropical Medicine
Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAN_IMPRESS_2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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