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Completed

NCT Number: NCT05890222

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sangath

Mormugao, Goa, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

(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

Treatment and study plan

Community Intervention

Behavioral

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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)

  9. 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

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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.

Sponsors and collaborators

Lead sponsor

Sangath

Other

Collaborators

  • Centre for Addiction and Mental Health
  • Harvard Medical School (HMS and HSDM)
  • London School of Hygiene and Tropical Medicine

Registry information

Acronym: IMPRESS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 6, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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