Climacteric Therapy With Applied Relaxation Using InterNet (CARIN)

Mats Hammar

Status

Terminated

Conditions

Menopause

Hot Flashes

Treatments

Behavioral: Applied relaxation

Study type

Interventional

Funder types

Other

Identifiers

NCT01245907

20100528/CARIN

Details and patient eligibility

About

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.

Full description

See above

Enrollment

46 patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

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