MenopauseNCT01488864
Applied Relaxation for Vasomotor Symptoms
A study testing Applied Relaxation (AR) in people with Menopause and Hot Flashes, run by Elizabeth Nedstrand at 1 site in Sweden.
Trial summary
The objectives of this study are to compare frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an untreated control-group (CG) and to investigate if Health Related Quality of Life improve in the AR-group compared to an untreated CG.To study… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menopause, Hot Flashes
- What is being tested?
- Applied Relaxation (AR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- postmenopausal women (at least 12 months since last menstrual bleeding occurred or in previously hysterectomised women a serum follicle-stimulating hormone (S-FSH) defined as postmenopausal level according to references at the local laboratory)
- More or equal to 7 moderate to severe hot flashes or more or equal at 50 hot flashes per week according to a two-week screening diary
- ability to understand and speak Swedish
- freely given informed consent
Who cannot join
- unstable thyroid or other metabolic disease
- treatment with hormone therapy (HT) or other complementary- or alternative treatments treatment for menopausal-related symptoms
- treatment with psychopharmacological drugs and/or sedatives d-un-treated psychiatric disease
- frequently exercising women (≥ 2h high-intensity activities/week)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University Hospital, Dept of Obstetrics and Gynecology
Linköping, 5851 85
About this study
Official title: Applied Relaxation for Vasomotor Symptoms in Postmenopausal Women - a Randomized, Controlled Trial
The objectives of this study are to compare frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an untreated control-group (CG) and to investigate if Health Related Quality of Life improve in the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change within the AR treated group compared with the control group.
Read the detailed description
Approximately 70% of women in Europe and North America experience hot flashes and night sweats during the climacteric period. Many women abstain from hormonal therapy because of side effects or contraindications such as breast cancer or thrombosis.
Different alternative therapies for alleviation of hot flashes are described in the literature. Both pharmacological treatments, different types of natural remedies, acupuncture, life-style changes and mind-body therapies are suggested as promising therapies. Applied relaxation (AR) is a technique influenced on cognitive behavioral therapy (CBT) using coping mechanism and conditioning. Previous study with healthy postmenopausal women showed promising results on hot flash frequency with an average decrease of more than 70 % with persisting effect three months after therapy and also HRQoL significantly increased probably due to better sleep and diminished vasomotor symptoms. But the method must be further investigated before strong evidence-based conclusion can be drawn.
Cortisol is a potent stress hormone regulated by the hypothalamic-pituitary axis. The factors underlying how alternative treatment works and the mechanism underlying improvements in symptoms are not fully understood.
- Conditions
- Menopause, Hot Flashes
- Being tested
- Applied Relaxation (AR)
- Keywords
- Hot flashes, Vasomotor symptoms, Menopause, Applied Relaxation, Health Related Quality of Life, Salivary cortisol
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Relaxation (AR)Behavioural
AR is a technique influenced on cognitive behavioral therapy using coping mechanism and conditioning. AR focuses on muscle relaxation, where breathing is used for the conditioning of the relaxation. AR implies participation in 10 group sessions during a period of 12 weeks. A therapist will see the women assigned to AR in a group consisted of 6-8 women. The weekly sessions will last for 60 minutes each and are based on a scheme from Öst. The women will be told to practice each component daily.
During the first session a lecture about menopause and about theories of the mechanisms behind hot flashes will be given.
The aim of applying AR in view of coping with vasomotor symptoms will be discussed. The group is given a rationale of applying AR as a coping technique for handling sudden unanticipated symptoms by quick calming down, and thus gaining control over the situation.
| Study group | Role | What they receive |
|---|---|---|
| Applied Relaxation (AR) | Experimental | Not described Receives: Behavioral: Applied Relaxation (AR) |
| Untreated Control Group (CG) | No intervention | The women assigned to CG will be told to act as an untreated control group i.e. not to use hormonal treatment, other alternative medication, natural remedies for hot flashes and even not acupuncture, mind-body therapies or intensive physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot flashes average number and severity
The average number and severity of hot flashes/24 hours in self-registered diaries during the 12th week
Measured: Baseline to 12 week after "start of treatment"
Secondary outcomes (5)
Hot flashes
The average number and severity of hot flashes per 24 hours after 3 months follow-up.
Measured: Baseline to 3 months after "end of treatment"
Hot flashes reduction of hot flashes
The reduction of hot flashes in women defined as responders. Responders are defined as women with ≥50% reduction of hot flashes.
Measured: Baseline to 3 months after "end of treatment"
Health Related Quality of Life
The total score in the Women Health Questionnaire measured at 12th week and after 3 months follow-up.
Measured: Baseline to 3 months "end of treatment"
Adverse Events
Adverse events documented by means of using open-ended questions at each contact.
Measured: Baseline to 3 months "end of treatment"
Salivary cortisol
Three samples of salivary cortisol (at awakening, 30 minutes after awakening, and at bedtime)were collected at baseline, after 12 weeks and 3 months after "end-of-treatment"
Measured: Baseline to 3 months after "end-of-treatment"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startMar 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Low drop-out rate and slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Nedstrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Nedstrand, Ostergotland County Council, Sweden
- Investigators
- Elizabeth Nedstrand, Md, PhD, Principal investigator, Ostergotland CC, University Hospital Dept. of Obstetrics and Gynecology, 582 85 Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488864
- Sponsor's protocol ID
- LiÖ/AR-2007
- Status last verified
- May 2012
- First submitted
- 6 Dec 2011
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Nedstrand E, Wijma K, Lindgren M, Hammar M. The relationship between stress-coping and vasomotor symptoms in postmenopausal women. Maturitas. 1998 Nov 30;31(1):29-34. doi: 10.1016/s0378-5122(98)00058-9.
PubMed 10091202Nedstrand 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.
PubMed 15917156Nedstrand E, Wijma K, Wyon Y, Hammar M. Vasomotor symptoms decrease in women with breast cancer randomized to treatment with applied relaxation or electro-acupuncture: a preliminary study. Climacteric. 2005 Sep;8(3):243-50. doi: 10.1080/13697130500118050.
PubMed 16390756Ost 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.
PubMed 3318800Hunter MS, Mann E. A cognitive model of menopausal hot flushes and night sweats. J Psychosom Res. 2010 Nov;69(5):491-501. doi: 10.1016/j.jpsychores.2010.04.005. Epub 2010 Jun 1.
PubMed 20955869Hunter MS, Coventry S, Hamed H, Fentiman I, Grunfeld EA. Evaluation of a group cognitive behavioural intervention for women suffering from menopausal symptoms following breast cancer treatment. Psychooncology. 2009 May;18(5):560-3. doi: 10.1002/pon.1414.
PubMed 18646246Innes KE, Selfe TK, Vishnu A. Mind-body therapies for menopausal symptoms: a systematic review. Maturitas. 2010 Jun;66(2):135-49. doi: 10.1016/j.maturitas.2010.01.016. Epub 2010 Feb 18.
PubMed 20167444Vegter S, Kolling P, Toben M, Visser ST, de Jong-van den Berg LT. Replacing hormone therapy--is the decline in prescribing sustained, and are nonhormonal drugs substituted? Menopause. 2009 Mar-Apr;16(2):329-35. doi: 10.1097/gme.0b013e31818c046b.
PubMed 19188855Hoffmann 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.
PubMed 16023804Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. doi: 10.1001/jama.295.17.2057.
PubMed 16670414Lethaby AE, Brown J, Marjoribanks J, Kronenberg F, Roberts H, Eden J. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001395. doi: 10.1002/14651858.CD001395.pub3.
PubMed 17943751Wyon Y, Wijma K, Nedstrand E, Hammar M. A comparison of acupuncture and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Climacteric. 2004 Jun;7(2):153-64. doi: 10.1080/13697130410001713814.
PubMed 15497904Lee MS, Shin BC, Ernst E. Acupuncture for treating menopausal hot flushes: a systematic review. Climacteric. 2009 Feb;12(1):16-25. doi: 10.1080/13697130802566980.
PubMed 19116803Speroff L, Gass M, Constantine G, Olivier S; Study 315 Investigators. Efficacy and tolerability of desvenlafaxine succinate treatment for menopausal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):77-87. doi: 10.1097/01.AOG.0000297371.89129.b3.
PubMed 18165395Wiklund 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.
PubMed 8259753
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Relaxation for Vasomotor Symptoms in Postmenopausal Women - a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01488864
- Acronym / sponsor ID
- LiÖ/AR-2007
- Conditions
- Menopause, Hot Flashes
- Keywords
- Hot flashes, Vasomotor symptoms, Menopause, Applied Relaxation, Health Related Quality of Life, Salivary cortisol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low drop-out rate and slow recruitment rate
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Elizabeth NedstrandUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to compare frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an untreated control-group (CG) and to investigate if Health Related Quality of Life improve in the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change within the AR treated group compared with the control group.
Detailed description
Approximately 70% of women in Europe and North America experience hot flashes and night sweats during the climacteric period. Many women abstain from hormonal therapy because of side effects or contraindications such as breast cancer or thrombosis.
Different alternative therapies for alleviation of hot flashes are described in the literature. Both pharmacological treatments, different types of natural remedies, acupuncture, life-style changes and mind-body therapies are suggested as promising therapies. Applied relaxation (AR) is a technique influenced on cognitive behavioral therapy (CBT) using coping mechanism and conditioning. Previous study with healthy postmenopausal women showed promising results on hot flash frequency with an average decrease of more than 70 % with persisting effect three months after therapy and also HRQoL significantly increased probably due to better sleep and diminished vasomotor symptoms. But the method must be further investigated before strong evidence-based conclusion can be drawn.
Cortisol is a potent stress hormone regulated by the hypothalamic-pituitary axis. The factors underlying how alternative treatment works and the mechanism underlying improvements in symptoms are not fully understood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Applied Relaxation (AR) | Experimental | Behavioral: Applied Relaxation (AR) |
| Untreated Control Group (CG) | No intervention | –The women assigned to CG will be told to act as an untreated control group i.e. not to use hormonal treatment, other alternative medication, natural remedies for hot flashes and even not acupuncture, mind-body therapies or intensive physical activity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- postmenopausal women (at least 12 months since last menstrual bleeding occurred or in previously hysterectomised women a serum follicle-stimulating hormone (S-FSH) defined as postmenopausal level according to references at the local laboratory)
- More or equal to 7 moderate to severe hot flashes or more or equal at 50 hot flashes per week according to a two-week screening diary
- ability to understand and speak Swedish
- freely given informed consent
Key exclusion criteria (4 listed)
- unstable thyroid or other metabolic disease
- treatment with hormone therapy (HT) or other complementary- or alternative treatments treatment for menopausal-related symptoms
- treatment with psychopharmacological drugs and/or sedatives d-un-treated psychiatric disease
- frequently exercising women (≥ 2h high-intensity activities/week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applied Relaxation (AR)AR is a technique influenced on cognitive behavioral therapy using coping mechanism and conditioning. AR focuses on muscle relaxation, where breathing is used for the conditioning of the relaxation. AR implies participation in 10 group sessions during a period of 12 weeks. A therapist will see the women assigned to AR in a group consisted of 6-8 women. The weekly sessions will last for 60 minutes each and are based on a scheme from Öst. The women will be told to practice each component daily. During the first session a lecture about menopause and about theories of the mechanisms behind hot flashes will be given. The aim of applying AR in view of coping with vasomotor symptoms will be discussed. The group is given a rationale of applying AR as a coping technique for handling sudden unanticipated symptoms by quick calming down, and thus gaining control over the situation. | Behavioural | Applied Relaxation (AR) |
Primary outcome
Hot flashes average number and severity
Time frame: Baseline to 12 week after "start of treatment"
The average number and severity of hot flashes/24 hours in self-registered diaries during the 12th week
5 secondary outcomes
Hot flashes
Time frame: Baseline to 3 months after "end of treatment"
Hot flashes reduction of hot flashes
Time frame: Baseline to 3 months after "end of treatment"
Health Related Quality of Life
Time frame: Baseline to 3 months "end of treatment"
Adverse Events
Time frame: Baseline to 3 months "end of treatment"
Salivary cortisol
Time frame: Baseline to 3 months after "end-of-treatment"
Results and safety
The study was stopped early (reason given: Low drop-out rate and slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
- Background: PubMed 10091202Nedstrand E, Wijma K, Lindgren M, Hammar M. The relationship between stress-coping and vasomotor symptoms in postmenopausal women. Maturitas. 1998 Nov 30;31(1):29-34. doi: 10.1016/s0378-5122(98)00058-9.
- Background: PubMed 15917156Nedstrand 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.
- Background: PubMed 16390756Nedstrand E, Wijma K, Wyon Y, Hammar M. Vasomotor symptoms decrease in women with breast cancer randomized to treatment with applied relaxation or electro-acupuncture: a preliminary study. Climacteric. 2005 Sep;8(3):243-50. doi: 10.1080/13697130500118050.
- Background: PubMed 3318800Ost 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.
- Background: PubMed 20955869Hunter MS, Mann E. A cognitive model of menopausal hot flushes and night sweats. J Psychosom Res. 2010 Nov;69(5):491-501. doi: 10.1016/j.jpsychores.2010.04.005. Epub 2010 Jun 1.
- Background: PubMed 18646246Hunter MS, Coventry S, Hamed H, Fentiman I, Grunfeld EA. Evaluation of a group cognitive behavioural intervention for women suffering from menopausal symptoms following breast cancer treatment. Psychooncology. 2009 May;18(5):560-3. doi: 10.1002/pon.1414.
- Background: PubMed 20167444Innes KE, Selfe TK, Vishnu A. Mind-body therapies for menopausal symptoms: a systematic review. Maturitas. 2010 Jun;66(2):135-49. doi: 10.1016/j.maturitas.2010.01.016. Epub 2010 Feb 18.
- Background: PubMed 19188855Vegter S, Kolling P, Toben M, Visser ST, de Jong-van den Berg LT. Replacing hormone therapy--is the decline in prescribing sustained, and are nonhormonal drugs substituted? Menopause. 2009 Mar-Apr;16(2):329-35. doi: 10.1097/gme.0b013e31818c046b.
- Background: PubMed 16023804Hoffmann 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.
- Background: PubMed 16670414Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. doi: 10.1001/jama.295.17.2057.
- Background: PubMed 17943751Lethaby AE, Brown J, Marjoribanks J, Kronenberg F, Roberts H, Eden J. Phytoestrogens for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001395. doi: 10.1002/14651858.CD001395.pub3.
- Background: PubMed 15497904Wyon Y, Wijma K, Nedstrand E, Hammar M. A comparison of acupuncture and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Climacteric. 2004 Jun;7(2):153-64. doi: 10.1080/13697130410001713814.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Nedstrand, Md, PhD principal investigator
Ostergotland CC, University Hospital Dept. of Obstetrics and Gynecology, 582 85 Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied Relaxation (AR) in people with Menopause and Hot Flashes, run by Elizabeth Nedstrand at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low drop-out rate and slow recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot flashes average number and severity (time frame: Baseline to 12 week after "start of treatment"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01488864, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2012.