How 2 Deal With PCOS: a Randomized Online Intervention for Women With PCOS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
Primary Objective:
-To study if an online individual brief CBT (group A) intervention is effective for psychological distress (anxiety and depression) compared to a CAU group in patients with PCOS at 3 and 6 months relative to baseline.
Secondary Objective(s):
- To study if an online group based brief CBT (group B) is more effective for anxiety and depression compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- To determine if an online individual brief CBT (group A) is effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- To determine if an group based brief CBT (group B) is more effective for improvements in QoL, coping strategies, body image and sleep quality compared to CAU in patients with PCOS at 3 and 6 months relative to baseline.
- If A and B are effective compared to CAU, we will compare online individual brief CBT (group A) to online group based brief CBT (group B) for anxiety and depression, QoL, coping strategies, body image and sleep quality compared to in patients with PCOS at 3 and 6 months relative to baseline.
详细描述
The online brief CBT intervention is designed to address three problems that have often been reported in women with PCOS. Therefore, the program contains three themes: Psychoeducation about PCOS; traditional CBT and problem-solving therapy.
Participants are randomized into one of three groups:
- individual treatment (A)
- group treatment (B)
- care as usual (CAU)
Treatment A and B include 5 sessions divided over a period of 3 months:
Week 1: Session 1 +homework assignments Week 3: Session 2 +homework assignments Week 5: Session 3 +homework assignments Week 8: Session 4 +homework assignments Week 12: Session 5 +homework assignments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with a confirmed diagnosis of PCOS based on the Rotterdam criteria
- •body Mass Index (BMI) ≥18.5 kg/m2
- •aged 18-55 years.
- •mild depressive symptoms or anxiety scores based on the Hospital Anxiety and Depression Scale (HADS) and/or a negative body image based on the Body Cathexis Scale (BCS).
排除标准
- •pregnancy
- •current treatment for clinical depression, anxiety disorders or eating disorders
- •suicidality (indicated by a score >2 on the Beck Depression Inventory II suicide item)
- •having an endocrine disease (diabetes mellitus, thyroid function disorders, Cushing's disease, adrenal tumors, and congenital adrenal hyperplasia)
- •inability to speak, read or write Dutch.
结局指标
主要结局
Depression
时间窗: at start, after 3 and 6 months
Changes in depression scores as assessed by the Hospital anxiety and depression scale (HADS). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. A higher score indicates higher distress.
Anxiety
时间窗: at start, after 3 and 6 months
Changes in anxiety scores as assessed by the Hospital anxiety and depression scale (HADS). HADS is a 14-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression. A higher score indicates higher distress.
次要结局
- QoL(at start, after 3 and 6 months)
- Coping(at start, after 3 and 6 months)
研究者
Geranne Jiskoot
Principal investigator
Erasmus Medical Center