Clinical trial NCT01245907: Climacteric Therapy With Applied Relaxation Using InterNet
Official title: Climacteric Therapy With Applied Relaxation Using InterNet - CARIN Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hot Flashes
Menopause
Keywords: Hot flashes
Menopause
HRQoL
Applied relaxation
Insomnia
Women's knowledge
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2010-11-23
Enrollment: 46
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: See above

Eligibility 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

Primary outcomes:
measure: Change in numbers of hot flashes per 24 h
timeFrame: Baseline to 10 weeks of treatment/control group
Secondary outcomes:
measure: Health related Quality of life (HRQoL)
timeFrame: Baseline to 10 weeks of treatment/control group
measure: Severity of insomnia
timeFrame: Baseline to 10 weeks of tratment/control group
measure: Women's knowledge about menopause and treatment of menopausal related symptoms
timeFrame: Baseline to 10 weeks of treatment/control group
measure: Change in numbers of hot flashes per 24 h, WHQ, ISI
timeFrame: Baseline to 6, 12 and 24 months after end treat treatment
measure: Adverse Event
timeFrame: Baseline to 10 weeks of treatment/control group
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: County Council of Östergötland, Kvinnokliniken
Study officials:
affiliation: Linkoeping University
name: Mats L Hammar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/01674820600724797.
citation: 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. doi: 10.1016/j.maturitas.2004.05.017.
citation: Ost LG. Applied relaxation: description of a coping technique and review of controlled studies. Behav Res Ther. 1987;25(5):397-409. doi: 10.1016/0005-7967(87)90017-9. No abstract available.
citation: 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. doi: 10.1016/s0005-7916(03)00026-0.
citation: Furmark T, Carlbring P, Hedman E, Sonnenstein A, Clevberger P, Bohman B, Eriksson A, Hallen A, Frykman M, Holmstrom 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.
citation: 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. doi: 10.1097/gme.0b013e31803816ca.
citation: 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. doi: 10.3109/00016349309021159.
citation: Lisspers J, Nygren A, Soderman E. Hospital Anxiety and Depression Scale (HAD): some psychometric data for a Swedish sample. Acta Psychiatr Scand. 1997 Oct;96(4):281-6. doi: 10.1111/j.1600-0447.1997.tb10164.x.
citation: 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. doi: 10.1016/s0022-5347(17)32530-2.
citation: 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.
citation: Berg G, Gottwall T, Hammar M, Lindgren R. Climacteric symptoms among women aged 60-62 in Linkoping, Sweden, in 1986. Maturitas. 1988 Oct;10(3):193-9. doi: 10.1016/0378-5122(88)90022-9.
citation: 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. doi: 10.1016/j.maturitas.2005.06.003.
citation: Lindh-Astrand L, Holm AC, Sydsjo 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.