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

November 22, 2010
April 24, 2014
February 2011
July 2012   (final data collection date for primary outcome measure)
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)
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 (waitinglist)
Complete list of historical versions of study NCT01245907 on ClinicalTrials.gov Archive Site
  • 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)
  • 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 (waiting list)
  • Severity of insomnia [ Time Frame: Baseline to 10 weeks of tratment/control group ] [ Designated as safety issue: No ]
    Insomnia meassured with Insomnia severity Index (ISI)at baseline and after 10 weeks. Comparison between treatment group and control group (waiting list)
  • 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 menopuase and treatment of menopausal related symptoms at 10 baseline and after 10 weeks. Comparison between the treatment group and the control group (waiting list)
  • 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 (waiting list)
Not Provided
Not Provided
 
Climacteric Therapy With Applied Relaxation Using InterNet
Climacteric Therapy With Applied Relaxation Using InterNet - CARIN Study

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.

See above

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hot Flashes
  • Menopause
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
  • 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
    Intervention: Behavioral: Applied relaxation
  • No Intervention: Waiting-list/control
    No intervention for 10 weeks but the same registrations and diaries and forms as the interventional group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
46
October 2012
July 2012   (final data collection date for primary outcome measure)

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
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01245907
20100528/CARIN
No
Mats Hammar, Ostergotland County Council
Mats Hammar
Linkoeping University
Principal Investigator: Mats L Hammar, MD Linkoeping University
Ostergotland County Council, Sweden
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP