Climacteric Therapy With Applied Relaxation Using InterNet
NCT01245907 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2014-04-25
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Linkoeping University
collaborator OTHER_GOV -
Mats Hammar
lead OTHER
Principal Investigators
-
Mats L Hammar, MD · Linkoeping University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2012-07-31
- Completion
- 2012-10-31
Countries
- Sweden
Study Locations
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