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.
See above
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Applied relaxation given by Internet during 10 weeks as a number of text-documents, audio-files and e-mail mediated support from therapists
County Council of Östergötland, Kvinnokliniken
Linköping, Sweden
Change in numbers of hot flashes per 24 h
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)
Time frame: Baseline to 10 weeks of treatment/control group
Health related Quality of life (HRQoL)
HRQoL measured with WHQ at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)
Time frame: Baseline to 10 weeks of treatment/control group
Severity of insomnia
Insomnia measured with Insomnia severity Index (ISI)at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)
Time frame: Baseline to 10 weeks of tratment/control group
Women's knowledge about menopause and treatment of menopausal related symptoms
Knowledge measured with a questionnaire measuring women's knowledge about menopause and treatment of menopausal related symptoms at 10 baseline and after 10 weeks. Comparison between the treatment group and the control group (waitlist)
Time frame: Baseline to 10 weeks of treatment/control group
Change in numbers of hot flashes per 24 h, WHQ, ISI
Assessment if changes from baseline to 10 weeks persist after 6, 12 and 24 months after end of treatment in the treatment group.
Time frame: Baseline to 6, 12 and 24 months after end treat treatment
Adverse Event
Open ended questions about occurence of adverse events during the treatment period. Comparison between the treatment group and the control group (waitlist)
Time frame: Baseline to 10 weeks of treatment/control group
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