Climacteric Therapy With Applied Relaxation Using InterNet

NCT01245907 | Terminated

• 1 other identifier: 20100528/CARIN
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes; Menopause

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in numbers of hot flashes per 24 h

  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)

  Baseline to 10 weeks of treatment/control group

Secondary Outcomes (5)

• Health related Quality of life (HRQoL)

  Baseline to 10 weeks of treatment/control group

• Severity of insomnia

  Baseline to 10 weeks of tratment/control group

• Women's knowledge about menopause and treatment of menopausal related symptoms

  Baseline to 10 weeks of treatment/control group

• Change in numbers of hot flashes per 24 h, WHQ, ISI

  Baseline to 6, 12 and 24 months after end treat treatment

• Adverse Event

  Baseline to 10 weeks of treatment/control group

Study Arms (2)

Applied relaxation

EXPERIMENTAL

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

Waiting-list/control

NO INTERVENTION

No intervention for 10 weeks but the same registrations and diaries and forms as the interventional group

Interventions

Applied relaxation BEHAVIORAL

Applied relaxation given by Internet during 10 weeks as a number of text-documents, audio-files and e-mail mediated support from therapists

Applied relaxation

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mats Hammar: lead
• Linkoeping University: collaborator

Study Sites (1)

County Council of Östergötland, Kvinnokliniken

Linköping, 581 85, Sweden

Location

Related Publications (13)

• 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.

  PMID: 17225620 BACKGROUND

• 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.

  PMID: 15917156 BACKGROUND

• 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.

  PMID: 3318800 BACKGROUND

• 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.

  PMID: 12899896 BACKGROUND

• 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.

  PMID: 19880935 BACKGROUND

• 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.

  PMID: 17519805 BACKGROUND

• 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.

  PMID: 8259753 BACKGROUND

• 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.

  PMID: 9350957 BACKGROUND

• 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.

  PMID: 8072086 BACKGROUND

• 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.

  PMID: 18364505 BACKGROUND

• 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.

  PMID: 3185293 BACKGROUND

• 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.

  PMID: 16023804 BACKGROUND

• 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.

  PMID: 25700856 DERIVED

MeSH Terms

Conditions

Hot Flashes; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mats L Hammar, MD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

SE (1)