Climacteric Therapy With Applied Relaxation Using InterNet

Not Applicable

Terminated

• Conditions: Hot Flashes; Menopause
• Interventions: Behavioral: Applied relaxation

• Registration Number: NCT01245907
• Lead Sponsor: Mats Hammar

Brief Summary

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.

Detailed Description

See above

Study Timeline

• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Study Start: 2011-02
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Applied relaxation	Applied relaxation	Applied relaxation given by Internet during 10 weeks as a number of text-documents, audio-files and e-mail mediated support from therapists

Primary Outcome Measures

Name	Time	Method
Change in numbers of hot flashes per 24 h	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)

Secondary Outcome Measures

Name	Time	Method
Health related Quality of life (HRQoL)	Baseline to 10 weeks of treatment/control group	HRQoL measured with WHQ at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)
Severity of insomnia	Baseline to 10 weeks of tratment/control group	Insomnia measured with Insomnia severity Index (ISI)at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)
Women's knowledge about menopause and treatment of menopausal related symptoms	Baseline to 10 weeks of treatment/control group	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)
Change in numbers of hot flashes per 24 h, WHQ, ISI	Baseline to 6, 12 and 24 months after end treat treatment	Assessment if changes from baseline to 10 weeks persist after 6, 12 and 24 months after end of treatment in the treatment group.
Adverse Event	Baseline to 10 weeks of treatment/control group	Open ended questions about occurence of adverse events during the treatment period. Comparison between the treatment group and the control group (waitlist)

Trial Locations

Locations (1)

County Council of Östergötland, Kvinnokliniken; 🇸🇪 Linköping, Sweden