Adapting to Better Life with Endometriosis (ABLE): A study to improve quality of life of women with endometriosis and investigate economic burden of the disease.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Change in quality of life as measured by WHOQOL-BREF
研究概览
简要总结
The ABLE study (Adapting to Better Life with Endometriosis) aims to improve the quality of life and reduce depressive symptoms in women diagnosed with endometriosis through a structured psychological intervention based on Behavioral Activation Therapy for Depression (BATD). The study also seeks to assess the economic burden of endometriosis on affected women and their families. This individual randomized controlled trial will be conducted at two sites in India, enrolling 480 participants ( 240 each in the intervention and control arms). Women will be randomized to either an intervention group receiving eight group-based BATD sessions or a control group receiving treatment as usual.
Study Hypothesis: The behavioral activation-based psychological intervention will lead to a significant improvement in quality of life and reduction in depression scores among women with endometriosis compared to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women will be eligible to participate if they meet all of the following criteria:
- •Aged between 18 and 49 years.
- •Have a confirmed diagnosis of endometriosis, either surgically or via transvaginal ultrasound.
- •Reside within 20 km of the study hospital site.
- •Have a PHQ-9 score of 5 or above, indicating at least mild depressive symptoms.
- •Are willing to engage in homework (30–40 minutes weekly) involving mindfulness activities and worksheets.
排除标准
- •Participants will be excluded if they meet any of the following:
- •Have a severe psychiatric disorder that impairs their ability to provide consent or attend sessions.
- •Are currently pregnant or planning pregnancy during the study period.
- •Have associated malignancies.
结局指标
主要结局
Change in quality of life as measured by WHOQOL-BREF
时间窗: 6 and 12 months
次要结局
- 1. Change in depression score using PHQ-9 at 6 and 12 months(2. Incremental cost analysis from provider perspective)
研究者
Preety Rajbangshi
The George Institute of Global heaalth, India