Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2023-08-01
2024-03-31
Brief Summary
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The pilot study has two primary objectives:
1. Evaluate the feasibility and acceptability of the study
2. Collect essential outcome data in preparation for the larger trial
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Detailed Description
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The primary objective of the OptimizeD study is to explore whether different patients respond differentially to a brief psychological treatment, known as the Healthy Activity Program, or a widely used generic Selective Serotonin Reuptake Inhibitor (fluoxetine). If such differences exist, this study aims to explore whether one can develop a machine learning-generated precision treatment rule to predict the most effective treatment based on individual baseline characteristics.
The pilot study has two primary objectives:
1. Evaluate the feasibility and acceptability of the study:
This pilot study will focus on assessing the feasibility and acceptability of the research protocol, including recruitment strategies, data collection methods, interventions, and risk management procedures. This evaluation will help refine and tailor the study procedures and play a critical role in setting the stage for the subsequent OptimizeD study.
2. Collect essential outcome data in preparation for the larger trial:
This study will test and refine the data instruments, gather initial data on efficacy, and refine the baseline assessment (which will serve as the cornerstone for the development of the precision treatment rule).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Healthy Activity Program (HAP)
HAP is a brief psychological treatment adapted from behavioral activation therapy, an empirically supported psychological treatment recommended by the World Health Organization.
Healthy Activity Program (HAP)
HAP, delivered over 6-8 sessions by non-specialist healthcare workers, has behavioural activation as the core psychological strategy along with other strategies such as problem-solving and activation of social networks.
Antidepressant medication (ADM)
Fluoxetine is a selective serotonin reuptake inhibitors (SSRIs) and one of the safest medications used to treat depression. It is a routinely used medication and part of the Essential Drug List (EDL) in India.
Antidepressant medication (ADM)
Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day which can be raised to 40 mg/day (the maximum mandated by treatment guidelines for primary care in India) at week 3 or 6 for patients who have yet to remit. Patients who cannot tolerate fluoxetine will be switched to escitalopram.
Interventions
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Healthy Activity Program (HAP)
HAP, delivered over 6-8 sessions by non-specialist healthcare workers, has behavioural activation as the core psychological strategy along with other strategies such as problem-solving and activation of social networks.
Antidepressant medication (ADM)
Patients assigned to antidepressant medication will start on fluoxetine 20 mg/day which can be raised to 40 mg/day (the maximum mandated by treatment guidelines for primary care in India) at week 3 or 6 for patients who have yet to remit. Patients who cannot tolerate fluoxetine will be switched to escitalopram.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a history of psychosis including schizophrenia spectrum disorders or bipolar disorder.
* Participants planning to move out of the study area during the follow-up period.
* Patients over 65 years of age with evidence of cognitive impairment - Patients who do not speak the study or local language (English or Hindi)
* Patients who are undergoing treatment for depression at the time of recruitment
18 Years
99 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Harvard School of Public Health (HSPH)
OTHER
Massachusetts General Hospital
OTHER
Centre for Addiction and Mental Health
OTHER
Brigham and Women's Hospital
OTHER
Vanderbilt University
OTHER
All India Institute of Medical Sciences, Bhopal
OTHER
Sangath
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
Responsible Party
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Vikram Patel
Paul Farmer Professor and Chair of the Department of Global Health and Social Medicine
Locations
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Sangath
Bhopal, Madhya Pradesh, India
Countries
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Related Links
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Study description
Other Identifiers
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IRB20-2144-pilot
Identifier Type: -
Identifier Source: org_study_id
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