NCT06056453已完成不适用
Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Center for Epidemiologic Studies-Depression Scale
研究概览
简要总结
The main purpose of this study is to find out whether taking part in a group-based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with PCOS duration > 3 months
- •12-17 years old
- •BMI > 75th percentile
- •CESD > 16
排除标准
- •Weekly or bi-weekly therapy with licensed behavioral health provider
- •Inability to speak, read, or write in English (teen)
- •Major medical conditions
- •HbA1c > 7.0%
- •Hormonal contraception < 3 months
- •Metformin < 3 months
- •Antidepressants/psychotropic medications < 4 weeks
结局指标
主要结局
Center for Epidemiologic Studies-Depression Scale
时间窗: 6-Month Follow-Up Assessment
Depression symptoms will be assessed by the Center for Epidemiologic Studies-Depression Scale. Scores range from 1 to 4. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
次要结局
- Emotional Eating Scale Adapted for Children(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)
- BMI(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)
- Insulin Resistance(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)
- Loss-of-Control Eating Disorder Questionnaire(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)
- Dysglycemia(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)
- Reward Based Eating Drive Scale(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)
- Dyslipidemia(Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment)
研究者
研究点 (2)
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