Clinical trial NCT05890222: IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
Official title: IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for depRESSion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Sangath
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Harvard Medical School (HMS and HSDM)
name: Centre for Addiction and Mental Health
First posted: 2023-06-06
Enrollment: 784
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: (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

Primary outcomes:
measure: Contact coverage
timeFrame: During recruitment
measure: Effectiveness coverage
timeFrame: Three months post recruitment
Secondary outcomes:
measure: Sustained effectiveness
timeFrame: Six months post recruitment
measure: Remission
timeFrame: Three months post recruitment
measure: Remission
timeFrame: Six months post recruitment
measure: Response to treatment
timeFrame: Three months post recruitment
measure: Response to treatment
timeFrame: Six months post recruitment
measure: Client Service Receipt Inventory
timeFrame: 3- and 6- months post recruitment
measure: WHO Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Baseline, 3- and 6- months post recruitment
measure: Survey form for collecting costs of receiving HAP intervention to patients
timeFrame: 3 months post recruitment
measure: Inventory form for collecting system-level economic costs of delivering interventions
timeFrame: Monthly, through study completion up to approximately 12 months
measure: Depression awareness
timeFrame: Baseline, 6, 12 and 18 months of implementation
measure: Perceived social support
timeFrame: 3- and 6- months post recruitment
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline, 3- and 6-months post-recruitment
measure: Treatment completion
timeFrame: Across 12 months of implementation
measure: Behavioral activation
timeFrame: Baseline, 3- and 6- months post recruitment.
Other outcomes:
Locations:
city: Goa
country: India
facility: Sangath
Study officials:
References: