OptimizeD Pilot Study
Study Details
Study Description
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:
-
Evaluate the feasibility and acceptability of the study
-
Collect essential outcome data in preparation for the larger trial
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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:
- 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: 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.
|
| Experimental: 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. |
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility as measured by recruitment rate [3-months]
We will assess enrolment rate for eligible participants
- Feasibility as measured by retention rate [3-months]
We will evaluate retention rates, which are calculated as the ratio of patients who complete the study to the total number of patients enrolled
- Feasibility of study assessments [3-months]
We will examine adherence rates to study procedures and the barriers to study participation reported by participants over the course of the study.
- Acceptability of interventions by participants [3-months]
We 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 Outcome Measures
- Change from Baseline in Depressive Symptoms [3-months]
We 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.
Eligibility Criteria
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:
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Women who are pregnant or are breastfeeding or lactating
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Patients with a history of psychosis including schizophrenia spectrum disorders or bipolar disorder.
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Participants planning to move out of the study area during the follow-up period.
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Patients over 65 years of age with evidence of cognitive impairment - Patients who do not speak the study or local language (English or Hindi)
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Patients who are undergoing treatment for depression at the time of recruitment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sangath | Bhopal | Madhya Pradesh | India | 462016 |
Sponsors and Collaborators
- Harvard Medical School (HMS and HSDM)
- National Institute of Mental Health (NIMH)
- Harvard School of Public Health (HSPH)
- Massachusetts General Hospital
- Centre for Addiction and Mental Health
- Brigham and Women's Hospital
- Vanderbilt University
- All India Institute of Medical Sciences, Bhopal
- Sangath
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IRB20-2144-pilot
- 1R01MH121632-01A1