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Completed

NCT Number: NCT06153004

OptimizeD Pilot Study

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sangath

Bhopal, Madhya Pradesh, 462016, India

About this study

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:

  • 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.

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Activity Program (HAP)

Behavioral

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)

Drug

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.

Primary outcomes

  1. Feasibility as measured by recruitment rate

    Time frame: 3-months

    The investigators will assess enrolment rate for eligible participants

  2. Feasibility as measured by retention rate

    Time frame: 3-months

    The investigators will evaluate retention rates, which are calculated as the ratio of patients who complete the study to the total number of patients enrolled

  3. Feasibility of study assessments

    Time frame: 3-months

    The investigators will examine adherence rates to study procedures and the barriers to study participation reported by participants over the course of the study.

  4. Acceptability of interventions by participants

    Time frame: 3-months

    The investigators will assess treatment compliance. For the HAP arm, this will be defined as having completed at least six sessions. For the ADM arm, this will be defined as having completed more than 80% of the recommended 12-week course of antidepressant medication.

Secondary outcomes

  1. Change from Baseline in Depressive Symptoms

    Time frame: 3-months

    The investigators will measure depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report scale to screen for symptoms of depression. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27, where higher scores indicate more severe depressive symptoms.

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Collaborators

  • All India Institute of Medical Sciences, Bhopal
  • Brigham and Women's Hospital
  • Centre for Addiction and Mental Health
  • Harvard School of Public Health (HSPH)
  • Massachusetts General Hospital
  • National Institute of Mental Health (NIMH)
  • Sangath
  • Vanderbilt University

Registry information

Official study title

Improving Outcomes in Depression in Primary Care in a Low Resource Setting: Evidence From a Pilot Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2023
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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