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Clinical Trial Summary

This pilot study aims to explore and refine the trial procedures that will be implemented in a larger-scale clinical trial scheduled to commence in March 2024 (NCT05944926). As part of this study, 60 patients with moderate to severe depression will be randomized to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication. 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


Clinical Trial Description

This pilot study will play a pivotal role in preparation for the forthcoming larger clinical trial, named the OptimizeD study, scheduled for launch in March 2024 (NCT05944926). 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06153004
Study type Interventional
Source Harvard Medical School (HMS and HSDM)
Contact
Status Completed
Phase Phase 3
Start date August 1, 2023
Completion date March 31, 2024

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