Hot FlashesMsFLASH-04NCT01936441
MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance
A study testing Cognitive Behavioral Therapy-Insomnia (CBT-I) in people with Hot Flashes and Menopause, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
Self-reported sleep complaints are common in peri- and postmenopausal women and have been identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep Disturbance, is a randomized, single-blind… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Menopause, Vasomotor Disturbance
- What is being tested?
- Cognitive Behavioral Therapy-Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2015
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female aged 40-65 years old
- Postmenopausal or perimenopausal, including:
- Women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval >=60 days in the past 12 months
- Women without a uterus or who have had a bi-lateral oophorectomy
- Experiencing hot flashes
- Experiencing insomnia (trouble sleeping) that is related to menopause
- Written informed consent signed
Who cannot join
- Pregnancy, intending pregnancy, or breastfeeding
- Current use of alcohol that is greater than 3 drinks per day
- Ever diagnosed for sleep apnea, restless legs syndrome, periodic leg movement disorder, random eye movement (REM) behavior disorder, or narcolepsy by a health care provider
- A job in the past month or planning to have a job in the next 3 months that requires shift work more than 3 times a week that involves working at night or on a rotating shift schedule
- Significant current major illness interfering with sleep or intervention participation (such as active cancer)
- Use of any prescription sleep medications more than 3 times a week or prescription medications that may affect sleep
Show all 9Show fewer
- Use of over-the-counter medications more than three times a week that are specifically for sleep, such as Tylenol PM, Nytol, Sominex, Tranquil Nighttime Sleep Aid, Unisom, ZzzQuil, benedryl, melatonin, valerian root, alcohol
- Current participation in another intervention study
- Inability or unwillingness to complete study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Menopausal Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) 04: A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women With Menopause-related Sleep Disturbance
Self-reported sleep complaints are common in peri- and postmenopausal women and have been identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The target population will include women in general good health, aged 40-65 years, who report symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the women will be randomly assigned to receive the behavioral intervention and half to receive the behavioral control.
The intervention arm participants will receive 6 sessions of a telephone-based, cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I). The control arm participants will receive telephone-based Menopause Education Control (MEC) that includes elements of sleep hygiene. Assessments for both groups will be collected at baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization.
Read more
The inclusion/exclusion criteria are designed to target broadly those midlife women who have menopause-related sleep disturbance and also report being bothered by vasomotor symptoms. This target population defines the clinical population seeking treatment for relief of menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to exclude women with significant medical problems likely to account for their sleep problems (instead of menopause), or likely to interfere with their ability to participate in the intervention. We include women taking hormone therapy or other medication who meet these criteria because they are part of the population seeking clinical care for relief of sleep disturbances.
Our primary objective is to develop an intervention that is generalizable to the greatest number of women and maximally translatable into real-world primary care practice.
- Conditions
- Hot Flashes, Menopause, Vasomotor Disturbance, Sleep
- Being tested
- Cognitive Behavioral Therapy-Insomnia (CBT-I), Menopause Education Control (MEC)
- Keywords
- Menopause, Vasomotor, Symptoms, Sleep, Cognitive Behavioral Therapy
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy-Insomnia (CBT-I)Behavioural
See Experimental Arm Description
Menopause Education Control (MEC)Behavioural
See Experimental Arm Description
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy-Insomnia (CBT-I) | Experimental | Participants will have contact with a menopause counselor 6 times over 8 weeks. The first session will be in-person at a private research office. All other contacts will be by telephone. Women unable to attend the in-person session will receive a phone call. All in-person and telephone consultations will be 20-30 minutes.
Participants will receive reading materials before each phone call relating to menopausal changes, menopausal changes in sleep and strategies for lessening menopause related sleep disturbances. A daily sleep diary will be completed each week during the 8-week intervention period. The day before each telephone session, the participant will email that week's completed diary to a secure email address accessible only by the counselor; women who are unable to use email will provide their data by telephone directly to the counselor. During the weekly telephone calls, the reading and materials will be discussed and the sleep diary will be reviewed. Receives: Behavioral: Cognitive Behavioral Therapy-Insomnia (CBT-I) |
| Menopause Education Control (MEC) | Placebo comparator | Participants will have contact with a menopause counselor 6 times over 8 weeks. The first session will be in-person at a private research office. All other contacts will be by telephone. Women who are unable to attend the in-person session will receive a phone call. All in-person and telephone consultations are designed to last 20-30 minutes. Participants will receive information about menopausal changes and ways to develop symptom management strategies. Women in the MEC will keep a daily sleep diary. The day before each telephone session, the participant will email that week's completed diary to a secure email address accessible only by the counselor; women who are unable to use email will provide their data by telephone directly to the counselor. During the weekly telephone calls, the reading material will be discussed and the sleep diary will be reviewed. Receives: Behavioral: Menopause Education Control (MEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Symptoms
The primary outcome is insomnia symptoms as assessed by the Insomnia Severity Index (ISI). The primary objective of this pilot trial is to determine the efficacy of Cognitive Behavioral Therapy-Insomnia (CBT-I) vs. Menopause Education Control (MEC) in improving insomnia symptoms among mid-life women with menopause-related sleep disturbance. 24-week follow-up will be additionally assessed.
Measured: 8 weeks
Secondary outcomes (1)
Sleep Quality
The secondary outcome is self-reported sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI). 24-week follow-up will be additionally assessed.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Katherine A Guthrie, PhD, Principal investigator, Fred Hutchinson Cancer CenterAndrea Z LaCroix, PhD, Principal investigator, University of California, San DiegoSusan M McCurry, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936441
- Sponsor's protocol ID
- MsFLASH-04
- Other IDs
- 1U01AG032699-01
- Acronym
- MsFLASH-04
- Status last verified
- Oct 2015
- First submitted
- 3 Sep 2013
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diem SJ, LaCroix AZ, Reed SD, Larson JC, Newton KM, Ensrud KE, Woods NF, Guthrie KA. Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: a pooled analysis of individual participant data from four MsFLASH trials. Menopause. 2020 Oct;27(10):1126-1136. doi: 10.1097/GME.0000000000001597.
PubMed 32701665Guthrie KA, Larson JC, Ensrud KE, Anderson GL, Carpenter JS, Freeman EW, Joffe H, LaCroix AZ, Manson JE, Morin CM, Newton KM, Otte J, Reed SD, McCurry SM. Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials. Sleep. 2018 Jan 1;41(1):zsx190. doi: 10.1093/sleep/zsx190.
PubMed 29165623McCurry SM, Guthrie KA, Morin CM, Woods NF, Landis CA, Ensrud KE, Larson JC, Joffe H, Cohen LS, Hunt JR, Newton KM, Otte JL, Reed SD, Sternfeld B, Tinker LF, LaCroix AZ. Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):913-20. doi: 10.1001/jamainternmed.2016.1795.
PubMed 27213646
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopausal Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) 04: A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women With Menopause-related Sleep Disturbance
- ClinicalTrials.gov ID
- NCT01936441
- Acronym / sponsor ID
- MsFLASH-04 / MsFLASH-04
- Conditions
- Hot Flashes, Menopause, Vasomotor Disturbance, Sleep
- Keywords
- Menopause, Vasomotor, Symptoms, Sleep, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Sep 2013 (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.
Self-reported sleep complaints are common in peri- and postmenopausal women and have been identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The target population will include women in general good health, aged 40-65 years, who report symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the women will be randomly assigned to receive the behavioral intervention and half to receive the behavioral control.
The intervention arm participants will receive 6 sessions of a telephone-based, cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I). The control arm participants will receive telephone-based Menopause Education Control (MEC) that includes elements of sleep hygiene. Assessments for both groups will be collected at baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization.
The inclusion/exclusion criteria are designed to target broadly those midlife women who have menopause-related sleep disturbance and also report being bothered by vasomotor symptoms. This target population defines the clinical population seeking treatment for relief of menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to exclude women with significant medical problems likely to account for their sleep problems (instead of menopause), or likely to interfere with their ability to participate in the intervention. We include women taking hormone therapy or other medication who meet these criteria because they are part of the population seeking clinical care for relief of sleep disturbances.
Our primary objective is to develop an intervention that is generalizable to the greatest number of women and maximally translatable into real-world primary care practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy-Insomnia (CBT-I) | Experimental | Behavioral: Cognitive Behavioral Therapy-Insomnia (CBT-I)Participants will have contact with a menopause counselor 6 times over 8 weeks. The first session will be in-person at a private research office. All other contacts will be by telephone. Women unable to attend the in-person session will receive a phone call. All in-person and telephone consultations will be 20-30 minutes. Participants will receive reading materials before each phone call relating to menopausal changes, menopausal changes in sleep and strategies for lessening menopause related sleep disturbances. A daily sleep diary will be completed each week during the 8-week intervention period. The day before each telephone session, the participant will email that week's completed diary to a secure email address accessible only by the counselor; women who are unable to use email will provide their data by telephone directly to the counselor. During the weekly telephone calls, the reading and materials will be discussed and the sleep diary will be reviewed. |
| Menopause Education Control (MEC) | Placebo comparator | Behavioral: Menopause Education Control (MEC)Participants will have contact with a menopause counselor 6 times over 8 weeks. The first session will be in-person at a private research office. All other contacts will be by telephone. Women who are unable to attend the in-person session will receive a phone call. All in-person and telephone consultations are designed to last 20-30 minutes. Participants will receive information about menopausal changes and ways to develop symptom management strategies. Women in the MEC will keep a daily sleep diary. The day before each telephone session, the participant will email that week's completed diary to a secure email address accessible only by the counselor; women who are unable to use email will provide their data by telephone directly to the counselor. During the weekly telephone calls, the reading material will be discussed and the sleep diary will be reviewed. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female aged 40-65 years old
- Postmenopausal or perimenopausal, including:
- Experiencing hot flashes
- Experiencing insomnia (trouble sleeping) that is related to menopause
- Written informed consent signed
Key exclusion criteria (9 listed)
- Pregnancy, intending pregnancy, or breastfeeding
- Current use of alcohol that is greater than 3 drinks per day
- Ever diagnosed for sleep apnea, restless legs syndrome, periodic leg movement disorder, random eye movement (REM) behavior disorder, or narcolepsy by a health care provider
- A job in the past month or planning to have a job in the next 3 months that requires shift work more than 3 times a week that involves working at night or on a rotating shift schedule
- Significant current major illness interfering with sleep or intervention participation (such as active cancer)
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 |
|---|---|---|
| Cognitive Behavioral Therapy-Insomnia (CBT-I)See Experimental Arm Description | Behavioural | Cognitive Behavioral Therapy-Insomnia (CBT-I) |
| Menopause Education Control (MEC)See Experimental Arm Description | Behavioural | Menopause Education Control (MEC) |
Primary outcome
Insomnia Symptoms
Time frame: 8 weeks
The primary outcome is insomnia symptoms as assessed by the Insomnia Severity Index (ISI). The primary objective of this pilot trial is to determine the efficacy of Cognitive Behavioral Therapy-Insomnia (CBT-I) vs. Menopause Education Control (MEC) in improving insomnia symptoms among mid-life women with menopause-related sleep disturbance. 24-week follow-up will be additionally assessed.
1 secondary outcome
Sleep Quality
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Derived from this study: PubMed 32701665Diem SJ, LaCroix AZ, Reed SD, Larson JC, Newton KM, Ensrud KE, Woods NF, Guthrie KA. Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: a pooled analysis of individual participant data from four MsFLASH trials. Menopause. 2020 Oct;27(10):1126-1136. doi: 10.1097/GME.0000000000001597.
- Derived from this study: PubMed 29165623Guthrie KA, Larson JC, Ensrud KE, Anderson GL, Carpenter JS, Freeman EW, Joffe H, LaCroix AZ, Manson JE, Morin CM, Newton KM, Otte J, Reed SD, McCurry SM. Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials. Sleep. 2018 Jan 1;41(1):zsx190. doi: 10.1093/sleep/zsx190.
- Derived from this study: PubMed 27213646McCurry SM, Guthrie KA, Morin CM, Woods NF, Landis CA, Ensrud KE, Larson JC, Joffe H, Cohen LS, Hunt JR, Newton KM, Otte JL, Reed SD, Sternfeld B, Tinker LF, LaCroix AZ. Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial. JAMA Intern Med. 2016 Jul 1;176(7):913-20. doi: 10.1001/jamainternmed.2016.1795.
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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.
Katherine A Guthrie, PhD principal investigator
Fred Hutchinson Cancer Center
Andrea Z LaCroix, PhD principal investigator
University of California, San Diego
Susan M McCurry, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy-Insomnia (CBT-I) in people with Hot Flashes and Menopause, run by Fred Hutchinson Cancer Center at 1 site in United States.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 22 Oct 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insomnia Symptoms (time frame: 8 weeks). 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 NCT01936441, which also lists 3 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 22 Oct 2015.