CTRI/2024/01/061932招募中3 期
Improving outcomes in Depression in Primary Care in a Low resource setting
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Depressive symptoms: measured by the Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
The OptimizeD study aims to improve outcomes in depression in primary care in India. As part of this study, we will randomize 1500 patients with moderate to severe depression to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication (fluoxetine). The objective of OptimizeD is to generate a precision treatment rule (PTR) for predicting which patient will respond better to either of the two monotherapies in routine primary care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
Depressive symptoms: measured by the Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline (week 0), during acute treatment (week 1, 2, 3, 6), primary endpoint (week 12), & follow-up assessments (6-, 9-, 12-month)
次要结局
- Generalized Anxiety Disorder Assessment (GAD-7)
- World Health Organization Well-Being Index (WHO-5)
- WHO Disability Assessment Schedule II (WHODAS-II)(Baseline, 3 months, 6 months, 9 months, 12 months)
- Minimal Clinically Important Difference (MCID)(3 months)
- Client Sociodemographic & Service Receipt Inventory (CSSRI)(Baseline, 3 months, 6 months, 9 months, 12 months)
研究者
研究点 (1)
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