Climacteric Therapy With Applied Relaxation Using InterNet - CARIN Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in numbers of hot flashes per 24 h
研究概览
简要总结
The aim is to evaluate effects of internet-based applied relaxation (a simplified version of cognitive behavioral therapy) for women with menopausal symptoms mainly vasomotoric symptom (VMS), i.e. hot flashes and sweating. Sixty postmenopausal women with VMS will be recruited and 30 randomized to applied relaxation (AR) via internet and 30 to a control group which is a non-treated waitlist group.
At baseline, after 10 weeks of therapy and six, 12 and 24 months after end of therapy women will be asked to fill in diaries about hot flashes and answer questionnaires on Quality of Life (Women's Health Questionnaire; WHQ, anxiety and depression measured with Hospital Anxiety and Depression Scale; HADS and one measuring sleep, Insomnia Severity Index; ISI as well as one about knowledge of the climacteric and hormone therapy).
The waiting list group will be offered internet based AR after 10 weeks with the same follow-up as the treatment group.
详细描述
See above
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A minimum of 7 moderate or severe hot flashes per 24 h or 50 hot flashes per week in average at least during one week before randomization (mild = hot flash without sweating as recognized by the woman but not disturbing the woman, moderate = hot flash and sweating as recognized by the woman but that does not lead to disruption of ongoing activity, severe = hot flash with sweating that leads to disruption of ongoing activity)
- •Natural menopause (at least 12 months without any menstrual bleedings at all)
- •At least 45 years of age during present year
- •Access to computer with Internet
- •Ability to read and speak Swedish
- •Freely informed concent for participation
排除标准
- •Induced menopause (e.g. hysterectomy, oophorectomy, chemotherapy, radiation therapy over abdominal- and/or pelvic region)
- •Early or premature menopause (before 45 years of age)
- •Breastcancer disease with ongoing therapy with antiestrogen or aromatase inhibitors
- •Ongoing usage or use during the last month of hormone therapy or other treatment aimed for hot flashes (e.g. natural remedies affecting hot flashes, acupuncture, dietary supplements aimed to treat hot flashes
- •Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or frequent use of benzodiazepines, drugs for insomnia(> 1 times/week)
- •Untreated or unstable endocrinological- or metabolic disease( e.g thyroid disease)
- •Undiagnosed vaginal bleeding after menopause
结局指标
主要结局
Change in numbers of hot flashes per 24 h
时间窗: Baseline to 10 weeks of treatment/control group
Numbers of hot flashes per 24 h daily recorded in hot flash diary from baseline throughout 10 weeks of treatment. Comparison between treatment group and control group (waitlist)
次要结局
- Health related Quality of life (HRQoL)(Baseline to 10 weeks of treatment/control group)
- Severity of insomnia(Baseline to 10 weeks of tratment/control group)
- Women's knowledge about menopause and treatment of menopausal related symptoms(Baseline to 10 weeks of treatment/control group)
- Change in numbers of hot flashes per 24 h, WHQ, ISI(Baseline to 6, 12 and 24 months after end treat treatment)
- Adverse Event(Baseline to 10 weeks of treatment/control group)
研究者
Mats Hammar
Professor
Ostergotland County Council, Sweden