Improving Outcomes in Depression in Primary Care in a Low Resource Setting

Launched by HARVARD MEDICAL SCHOOL (HMS AND HSDM) · Jul 2, 2023

Keywords

ClinConnect Summary

The OptimizeD study is a clinical trial designed to find better ways to treat depression in primary care settings in India. The trial will involve 1,500 adults who have moderate to severe depression. Participants will be randomly assigned to one of two treatment options: a type of therapy called the Healthy Activity Program (HAP), which focuses on increasing daily activities to improve mood, or an antidepressant medication called fluoxetine. The goal is to learn which treatment works best for different people and to identify those who may need more specialized care.

To be eligible for the study, participants need to be at least 18 years old and have a diagnosis of moderate to severe depression, as indicated by a specific questionnaire. However, individuals who are pregnant or breastfeeding, those with certain mental health conditions like psychosis, or those currently receiving treatment for depression cannot participate. Throughout the study, participants will be monitored and supported as researchers compare the effectiveness and costs of the two treatments. This research aims to improve depression care in low-resource settings and help doctors make more personalized treatment choices for their patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants will be adults aged 18 or over of any gender attending one of the selected Primary Health Care Centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the Patient Health Questionnaire-9 (PHQ-9).
• Exclusion Criteria:
• • 1. Women who are pregnant or are breastfeeding or lactating
• • 2. Patients with a history of psychosis, including schizophrenia spectrum disorders or bipolar disorder.
• • 3. Participants planning to permanently move out of the study area during the follow-up period.
• • 4. Patients with evidence of cognitive impairment.
• • 5. Patients who do not speak either English or Hindi.
• • 6. Patients who are undergoing treatment for depression at the time of recruitment or who completed treatment within one month prior to recruitment
• • 7. Patients at imminent risk for suicide
• • 8. Patients from households in which another member has been recruited into the study