Clinical trial NCT06153004: OptimizeD Pilot Study
Official title: Improving Outcomes in Depression in Primary Care in a Low Resource Setting: Evidence From a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Depressive Disorder
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Harvard School of Public Health (HSPH)
name: Massachusetts General Hospital
name: Centre for Addiction and Mental Health
name: Brigham and Women's Hospital
name: Vanderbilt University
name: All India Institute of Medical Sciences, Bhopal
name: Sangath
First posted: 2023-12-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fluoxetine versus a contextually adapted version of behavioral activation called the Healthy Activity Program (HAP) delivered by non-specialists for the treatment of depression
Primary purpose: TREATMENT

Brief 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

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* Participants will be adults aged 18 or over of any gender attending one of eight 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:

* Women who are pregnant or are breastfeeding or lactating
* 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

Primary outcomes:
measure: Feasibility as measured by recruitment rate
timeFrame: 3-months
measure: Feasibility as measured by retention rate
timeFrame: 3-months
measure: Feasibility of study assessments
timeFrame: 3-months
measure: Acceptability of interventions by participants
timeFrame: 3-months
Secondary outcomes:
measure: Change from Baseline in Depressive Symptoms
timeFrame: 3-months
Other outcomes:
Locations:
city: Bhopal
country: India
facility: Sangath
state: Madhya Pradesh
Study officials:
References: