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Unacceptable high drop-out rate.
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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Waiting-list/control | No Intervention | No intervention for 10 weeks but the same registrations and diaries and forms as the interventional group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health related Quality of life (HRQoL) | HRQoL measured with WHQ at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist) | Baseline to 10 weeks of treatment/control group |
| Severity of insomnia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mats L Hammar, MD | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| County Council of Östergötland, Kvinnokliniken | Linköping | 581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17225620 | Background | 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. | |
| 15917156 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 6, 2023 | |
| Reset | May 2, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 6, 2023 | May 2, 2024 |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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Insomnia measured with Insomnia severity Index (ISI)at baseline and after 10 weeks. Comparison between treatment group and control group (waitlist)
| Baseline to 10 weeks of tratment/control group |
| Women's knowledge about menopause and treatment of menopausal related symptoms | 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) | Baseline to 10 weeks of treatment/control group |
| Change in numbers of hot flashes per 24 h, WHQ, ISI | Assessment if changes from baseline to 10 weeks persist after 6, 12 and 24 months after end of treatment in the treatment group. | Baseline to 6, 12 and 24 months after end treat treatment |
| Adverse Event | Open ended questions about occurence of adverse events during the treatment period. Comparison between the treatment group and the control group (waitlist) | Baseline to 10 weeks of treatment/control group |
| 3318800 | 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. |
| 12899896 | 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. |
| 19880935 | 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. |
| 17519805 | 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. |
| 8259753 | 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. |
| 9350957 | 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. |
| 8072086 | 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. |
| 18364505 | 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. |
| 3185293 | 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. |
| 16023804 | 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. |
| 25700856 | Derived | 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. |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |