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

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: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Community Intervention; Behavioral: Healthy Activity Program (HAP)

• Study Type: Interventional
• Enrollment (Estimated): 1680
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Goa, India
    • Recruiting
    • Sangath
    • Contact: Urvita Bhatia; Phone Number: +91-95525 30557; Email: urvita.bhatia@sangath.in
    • Contact: Yashi Gandhi; Email: yashi.gandhi@sangath.in
    • Principal Investigator: Abhijit Nadkarni

Participation Criteria

Eligibility Criteria

• 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 >15) on the Patient Health Questionnaire-9 items (PHQ-9)
• Intend to reside in the trial clusters for at least 3 months (to enhance the likelihood of completion of treatment)

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
• Patients who do not have access to a mobile phone as that will be needed for communicating with the counsellors and Sangathis, for example, to follow-up if the patient misses an appointment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Three months post 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained effectiveness	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	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	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	>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	>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
Client Service Receipt Inventory	Out-of-pocket costs for receiving care and the related non-medical costs	Baseline, 3- and 6- months post recruitment
Depression awareness	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 and 12 months of implementation
Treatment completion	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)	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
Survey form for collecting costs of receiving HAP intervention to patients	Out-of-pocket costs for receiving HAP intervention (e.g. time loss, travel)	Baseline, 3 months post recruitment
Inventory form for collecting system-level economic costs of delivering interventions	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	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)	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	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.

Collaborators and Investigators

• Sponsor: Sangath
• Collaborators: Harvard Medical School (HMS and HSDM); London School of Hygiene and Tropical Medicine; Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID 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