Climacteric Therapy With Applied Relaxation Using InterNet (CARIN)

This study has been terminated.
(Unacceptable high drop-out rate.)
Sponsor:
Collaborator:
Linkoeping University
Information provided by (Responsible Party):
Mats Hammar, Ostergotland County Council
ClinicalTrials.gov Identifier:
NCT01245907
First received: November 22, 2010
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention
Hot Flashes
Menopause
Behavioral: Applied relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Climacteric Therapy With Applied Relaxation Using InterNet - CARIN Study

Resource links provided by NLM:


Further study details as provided by Ostergotland County Council, Sweden:

Primary Outcome Measures:
  • Change in numbers of hot flashes per 24 h [ Time Frame: Baseline to 10 weeks of treatment/control group ] [ Designated as safety issue: No ]
    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:
  • Health related Quality of life (HRQoL) [ Time Frame: Baseline to 10 weeks of treatment/control group ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Open ended questions about occurence of adverse events during the treatment period. Comparison between the treatment group and the control group (waitlist)


Enrollment: 46
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245907

Locations
Sweden
County Council of Östergötland, Kvinnokliniken
Linköping, Sweden, 581 85
Sponsors and Collaborators
Mats Hammar
Linkoeping University
Investigators
Principal Investigator: Mats L Hammar, MD Linkoeping University
  More Information

Publications:

Responsible Party: Mats Hammar, Professor, Ostergotland County Council
ClinicalTrials.gov Identifier: NCT01245907     History of Changes
Other Study ID Numbers: 20100528/CARIN
Study First Received: November 22, 2010
Last Updated: April 24, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Ostergotland County Council, Sweden:
Hot flashes
Menopause
HRQoL
Applied relaxation
Insomnia
Women's knowledge

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014