Improving Outcomes in Depression in Primary Care in a Low Resource Setting: Evidence From a Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Feasibility of study assessments
研究概览
简要总结
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
详细描述
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. 2. Collect essential outcome data in preparation for the larger trial:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masked (blinded) field-based assessors will conduct all outcome assessments
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Healthy Activity Program (HAP) (Behavioral)
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.
干预措施: Antidepressant medication (ADM) (Drug)
结局指标
主要结局
Feasibility of study assessments
时间窗: 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.
Acceptability of interventions by participants
时间窗: 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.
Feasibility as measured by retention rate
时间窗: 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
Feasibility as measured by recruitment rate
时间窗: 3-months
The investigators will assess enrolment rate for eligible participants
次要结局
- Change from Baseline in Depressive Symptoms(3-months)
研究者
Vikram Patel
Paul Farmer Professor and Chair of the Department of Global Health and Social Medicine
Harvard Medical School (HMS and HSDM)