Climacteric Therapy With Applied Relaxation Using InterNet - Full Text View

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:

MedlinePlus related topics: Menopause

U.S. FDA Resources

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:

Nedstrand E, Wyon Y, Hammar M, Wijma K. Psychological well-being improves in women with breast cancer after treatment with applied relaxation or electro-acupuncture for vasomotor symptom. J Psychosom Obstet Gynaecol. 2006 Dec;27(4):193-9.

Nedstrand E, Wijma K, Wyon Y, Hammar M. Applied relaxation and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Maturitas. 2005 Jun 16;51(2):154-62.

Ost LG. Applied relaxation: description of a coping technique and review of controlled studies. Behav Res Ther. 1987;25(5):397-409. Review.

Carlbring P, Ekselius L, Andersson G. Treatment of panic disorder via the Internet: a randomized trial of CBT vs. applied relaxation. J Behav Ther Exp Psychiatry. 2003 Jun;34(2):129-40.

Furmark T, Carlbring P, Hedman E, Sonnenstein A, Clevberger P, Bohman B, Eriksson A, Hållén A, Frykman M, Holmström A, Sparthan E, Tillfors M, Ihrfelt EN, Spak M, Eriksson A, Ekselius L, Andersson G. Guided and unguided self-help for social anxiety disorder: randomised controlled trial. Br J Psychiatry. 2009 Nov;195(5):440-7. doi: 10.1192/bjp.bp.108.060996.

Lindh-Astrand L, Brynhildsen J, Hoffmann M, Kjellgren KI, Hammar M. Knowledge of reproductive physiology and hormone therapy in 53- to 54-year-old Swedish women: a population-based study. Menopause. 2007 Nov-Dec;14(6):1039-46.

Wiklund I, Karlberg J, Lindgren R, Sandin K, Mattsson LA. A Swedish version of the Women's Health Questionnaire. A measure of postmenopausal complaints. Acta Obstet Gynecol Scand. 1993 Nov;72(8):648-55.

Lisspers J, Nygren A, Söderman E. Hospital Anxiety and Depression Scale (HAD): some psychometric data for a Swedish sample. Acta Psychiatr Scand. 1997 Oct;96(4):281-6.

Karling P, Hammar M, Varenhorst E. Prevalence and duration of hot flushes after surgical or medical castration in men with prostatic carcinoma. J Urol. 1994 Oct;152(4):1170-3.

Holmberg L, Iversen OE, Rudenstam CM, Hammar M, Kumpulainen E, Jaskiewicz J, Jassem J, Dobaczewska D, Fjosne HE, Peralta O, Arriagada R, Holmqvist M, Maenpaa J; HABITS Study Group. Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Cancer Inst. 2008 Apr 2;100(7):475-82. doi: 10.1093/jnci/djn058. Epub 2008 Mar 25. Erratum in: J Natl Cancer Inst. 2008 May 7;100(9):685. Maenpa, Johanna [corrected to Maenpaa, Johanna].

Berg G, Gottwall T, Hammar M, Lindgren R. Climacteric symptoms among women aged 60-62 in Linköping, Sweden, in 1986. Maturitas. 1988 Oct;10(3):193-9. Erratum in: Maturitas 1988 Dec;10(4):363. Gottgall T [corrected to Gottwall T].

Hoffmann M, Hammar M, Kjellgren KI, Lindh-Astrand L, Brynhildsen J. Changes in women's attitudes towards and use of hormone therapy after HERS and WHI. Maturitas. 2005 Sep 16;52(1):11-7.


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

ClinicalTrials.gov processed this record on February 27, 2015

Climacteric Therapy With Applied Relaxation Using InterNet (CARIN)