Internet- and Mobile-based Group Treatment of Menopausal and Psychological Health of Chinese Women: a Study Protocol for a Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Greene Climacteric Scale
研究概览
简要总结
Background: Menopause syndrome generally occurs with and is related to psychological problems. However, Internet- and mobile-based group treatment (imGT) may improve women's physiological and psychological conditions.
Objective: To investigate the efficacy of group treatment with or without Internet- and mobile-based treatment of menopause, mood swings and quality of life status.
Methods: This protocol is for a randomized controlled clinical trial with a sample of 144 menopausal women divided into 2 groups: imGT and face-to-face group treatment (ffGT). The primary outcome will be the menopausal symptom improvement of the two groups, as assessed by Greene Climacteric Scale. The secondary outcomes will be quality of life, assessed by the Short Form 36 Health Survey Questionnaire; insomnia, assessed by the Pittsburgh Sleep Quality Inventory; anxiety, assessed by the Hamilton Anxiety Rating Scale; and therapeutic alliance, assessed by the Working Alliance Inventory-Short Revised. imGT will be performed once a week for 1.5 hours for 10 weeks with a daily Punched-in on the WeChat App; ffGT will be performed once a week for 1.5 hours for 10 weeks. All outcomes will be assessed at baseline, at a post-intervention evaluation (week 10), and at a follow-up evaluation (week 22).
Discussion: This study will be the first clinical trial to examine the effects of imGT on menopausal women in China. If imGT is found to be equivalent to or superior to ffGT, it will facilitate easier access to menopausal health services, which may be feasible to offer to other medical institution.
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 40~60, in menopausal transition or post-menopause, according to the STRAW +10 definition
- •have Internet access
- •have mobile phone access
- •have sufficient knowledge of the Chinese language
- •have scored in the clinical range for menopause syndrome from the psychiatric interview
- •have signed a consent form that will be provided to eligible participants.
排除标准
- •not completing informed consent
- •presence of any of the following diseases: hyperthyroidism, coronary atherosclerotic heart disease, hypertension (BP≥140/90 mmHg), pheochromocytoma, neurasthenia, psychosis, or other diseases closely related to the main disease
- •troublesome drinking
- •drug use (hypnotics or hormone therapy) in the past 14 days, which might affect mood.
研究组 & 干预措施
Internet- and mobile-based group treatment
the therapy consists of 10 modules (15 hours in total) in groups of 8 participants each over a period of 10 weeks and one follow-up meeting (2 hours) 12 weeks after the 10th module (week 22). Each module is adapted from the previous literature on CBT rationale and will be conducted online on WeChat, a mobile social networking software with 1 billion users in 2018. First, we will establish a WeChat group containing the imGT group members and psychiatrists, in which everyone can talk instantly. The interactive treatments will be conducted every Friday evening for a duration of 1.5 hours via text, audio or video messaging.
干预措施: group behavioral cognitive therapy (Behavioral)
Face-to-face group treatment
10 modules will be conducted every weekend in the psychological counseling room of The Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University.
干预措施: group behavioral cognitive therapy (Behavioral)
结局指标
主要结局
Greene Climacteric Scale
时间窗: week 22
Menopause symptoms of one follow-up meeting
次要结局
- Pittsburgh Sleep Quality Index(week 22)
- Client Satisfaction Qestionnaire-8 (CSQ-8)(week 10)
- The Short Form 36 Health Survey Questionnaire(week 22)
- The Hamilton Anxiety Rating Scale(week 22)
- The Working Alliance Inventory-Short Revised(week 10)
研究者
Dan Li
Principal investigator
Southeast University, China