Climacteric Therapy With Applied Relaxation Using InterNet (CARIN)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hot Flashes; Menopause	Behavioral: Applied relaxation	Not Applicable

Detailed Description:

See above

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	46 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Climacteric Therapy With Applied Relaxation Using InterNet - CARIN Study
Study Start Date :	February 2011
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	October 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change in numbers of hot flashes per 24 h [ Time Frame: Baseline to 10 weeks of treatment/control group ]
   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 :

1. Health related Quality of life (HRQoL) [ Time Frame: Baseline to 10 weeks of treatment/control group ]
   HRQoL measured with WHQ at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)
2. Severity of insomnia [ Time Frame: Baseline to 10 weeks of tratment/control group ]
   Insomnia measured with Insomnia severity Index (ISI)at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)
3. Women's knowledge about menopause and treatment of menopausal related symptoms [ Time Frame: Baseline to 10 weeks of treatment/control group ]
   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)
4. Change in numbers of hot flashes per 24 h, WHQ, ISI [ Time Frame: Baseline to 6, 12 and 24 months after end treat treatment ]
   Assessment if changes from baseline to 10 weeks persist after 6, 12 and 24 months after end of treatment in the treatment group.
5. Adverse Event [ Time Frame: Baseline to 10 weeks of treatment/control group ]
   Open ended questions about occurence of adverse events during the treatment period. Comparison between the treatment group and the control group (waitlist)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	45 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lindh-Åstrand L, Holm AC, Sydsjö G, Andersson G, Carlbring P, Nedstrand E. Internet-delivered applied relaxation for vasomotor symptoms in postmenopausal women: lessons from a failed trial. Maturitas. 2015 Apr;80(4):432-4. doi: 10.1016/j.maturitas.2015.01.010. Epub 2015 Feb 2.

Responsible Party:	Mats Hammar, Professor, Ostergotland County Council
ClinicalTrials.gov Identifier:	NCT01245907 History of Changes
Other Study ID Numbers:	20100528/CARIN
First Posted:	November 23, 2010
Last Update Posted:	April 25, 2014
Last Verified:	April 2014

Keywords provided by Mats Hammar, Ostergotland County Council:

Hot flashes; Menopause; HRQoL	Applied relaxation; Insomnia; Women's knowledge

Additional relevant MeSH terms:

Hot Flashes; Signs and Symptoms