Climacteric Therapy With Applied Relaxation Using InterNet (CARIN)
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ClinicalTrials.gov Identifier: NCT01245907 |
Recruitment Status
:
Terminated
(Unacceptable high drop-out rate.)
First Posted
: November 23, 2010
Last Update Posted
: April 25, 2014
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hot Flashes Menopause | Behavioral: Applied relaxation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Climacteric Therapy With Applied Relaxation Using InterNet - CARIN Study |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 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
|
Behavioral: 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
|
No Intervention: Waiting-list/control
No intervention for 10 weeks but the same registrations and diaries and forms as the interventional group
|
- Change in numbers of hot flashes per 24 h [ Time Frame: 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)
- Health related Quality of life (HRQoL) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)

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Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245907
Sweden | |
County Council of Östergötland, Kvinnokliniken | |
Linköping, Sweden, 581 85 |
Principal Investigator: | Mats L Hammar, MD | Linkoeping University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Mats Hammar, Professor, Ostergotland County Council |
ClinicalTrials.gov Identifier: | NCT01245907 History of Changes |
Other Study ID Numbers: |
20100528/CARIN |
First Posted: | November 23, 2010 Key Record Dates |
Last Update Posted: | April 25, 2014 |
Last Verified: | April 2014 |
Keywords provided by Mats Hammar, Ostergotland County Council:
Hot flashes Menopause HRQoL |
Applied relaxation Insomnia Women's knowledge |
Additional relevant MeSH terms:
Hot Flashes Signs and Symptoms |