A Phase 3 interventional study of Healthy Activity Program (HAP) and Antidepressant medication (ADM) in Depression and Depressive Disorder, sponsored by Harvard Medical School (HMS and HSDM). Completed at 1 site in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Harvard Medical School (HMS and HSDM) · Phase 3, Interventional, and Treatment
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:
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.
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).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 76 is close to the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Harvard Medical School (HMS and HSDM) is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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)
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.
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.
Feasibility as measured by recruitment rate
The investigators will assess enrolment rate for eligible participants
Time frame: 3-months
Feasibility as measured by retention rate
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
Time frame: 3-months
Feasibility of study assessments
The investigators will examine adherence rates to study procedures and the barriers to study participation reported by participants over the course of the study.
Time frame: 3-months
Acceptability of interventions by participants
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.
Time frame: 3-months
Change from Baseline in Depressive Symptoms
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.
Time frame: 3-months
Plan to share: Yes — Individual participant data will be shared through the National Institute of Mental Health (NIMH) Data Archive. To ensure participant privacy and data security, all shared data will be de-identified according to established protocols and guidelines. The data sharing plan will be periodically reviewed and updated, as necessary, to align with evolving best practices, policies, and guidelines for data sharing.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Harvard Medical School (HMS and HSDM)