MenopauseNCT01933295
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
A study testing Cognitive Behavioral Therapy for Insomnia, Sleep Education and Sleep Restriction Therapy in people with Menopause, run by Christopher Drake at 1 site in United States.
Trial summary
Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia, Sleep Education and Sleep Restriction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2014to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-menopausal insomnia
Who cannot join
- unstable medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.
Read the detailed description
Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.
Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.
Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).
Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.
- Conditions
- Menopause
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Sleep Education, Sleep Restriction Therapy
- Keywords
- treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Sleep EducationBehavioural
Sleep Restriction TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sleep Education | Active comparator | Weekly educational emails sent to participants with information about sleep science and tips for better sleep. Receives: Behavioral: Sleep Education |
| Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral treatment (5 component) Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Sleep Restriction Therapy | Experimental | Brief sleep restriction therapy. Receives: Behavioral: Sleep Restriction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diary Based Sleepiness
Diaries were based on the consensus sleep diaries but were modified to also measure patient sleepiness over the past 24 hours on a 0 "none" to 10 "highest" scale. Scores in this study represent the daily mean for sleepiness ratings for each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)
Measured: 8 months
Secondary outcomes (2)
Fatigue Severity Scale (FSS).
Scores range from 9 to 63, with higher scores indicating greater fatigue, and scores above 36 indicate severe fatigue.
Data collected at pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline).
Measured: 8 months
Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale
Domain scores range from 0 to 100 with higher scores indicating better quality of life.
Data collected at each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study start1 Mar 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Drake
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Wayne State University, University of Michigan
- Responsible party
- Sponsor-investigator, Christopher Drake, Henry Ford Health System
- Investigators
- Christopher Drake, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933295
- Sponsor's protocol ID
- NR013959
- Other IDs
- R01NR013959-01
- Status last verified
- Feb 2023
- First submitted
- 6 Sep 2012
- Last updated
- 22 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kalmbach DA, Cheng P, Roth T, Sagong C, Drake CL. Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women. Sleep Med. 2020 Sep;73:82-92. doi: 10.1016/j.sleep.2020.04.024. Epub 2020 May 7.
PubMed 32799029Cheng P, Kalmbach D, Fellman-Couture C, Arnedt JT, Cuamatzi-Castelan A, Drake CL. Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial. J Clin Sleep Med. 2020 Feb 15;16(2):193-198. doi: 10.5664/jcsm.8164. Epub 2020 Jan 13.
PubMed 31992407Kalmbach DA, Cheng P, Arnedt JT, Cuamatzi-Castelan A, Atkinson RL, Fellman-Couture C, Roehrs T, Drake CL. Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education. J Clin Sleep Med. 2019 Jul 15;15(7):999-1010. doi: 10.5664/jcsm.7882.
PubMed 31383238Kalmbach DA, Cheng P, Arnedt JT, Anderson JR, Roth T, Fellman-Couture C, Williams RA, Drake CL. Treating insomnia improves depression, maladaptive thinking, and hyperarousal in postmenopausal women: comparing cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy, and sleep hygiene education. Sleep Med. 2019 Mar;55:124-134. doi: 10.1016/j.sleep.2018.11.019. Epub 2018 Dec 28.
PubMed 30785053Drake CL, Kalmbach DA, Arnedt JT, Cheng P, Tonnu CV, Cuamatzi-Castelan A, Fellman-Couture C. Treating chronic insomnia in postmenopausal women: a randomized clinical trial comparing cognitive-behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education. Sleep. 2019 Feb 1;42(2):zsy217. doi: 10.1093/sleep/zsy217.
PubMed 30481333
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
- ClinicalTrials.gov ID
- NCT01933295
- Acronym / sponsor ID
- NR013959
- Conditions
- Menopause
- Keywords
- treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Christopher DrakeUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Wayne State University, University of Michigan
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Posted 22 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.
Detailed description
Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.
Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.
Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).
Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleep Education | Active comparator | Behavioral: Sleep EducationWeekly educational emails sent to participants with information about sleep science and tips for better sleep. |
| Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaBehavioral treatment (5 component) |
| Sleep Restriction Therapy | Experimental | Behavioral: Sleep Restriction TherapyBrief sleep restriction therapy. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post-menopausal insomnia
Key exclusion criteria (1 listed)
- unstable medical conditions
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 for Insomnia | Behavioural | Cognitive Behavioral Therapy for Insomnia |
| Sleep Education | Behavioural | Sleep Education |
| Sleep Restriction Therapy | Behavioural | Sleep Restriction Therapy |
Primary outcome
Diary Based Sleepiness
Time frame: 8 months
Diaries were based on the consensus sleep diaries but were modified to also measure patient sleepiness over the past 24 hours on a 0 "none" to 10 "highest" scale. Scores in this study represent the daily mean for sleepiness ratings for each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)
2 secondary outcomes
Fatigue Severity Scale (FSS).
Time frame: 8 months
Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale
Time frame: 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32799029Kalmbach DA, Cheng P, Roth T, Sagong C, Drake CL. Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women. Sleep Med. 2020 Sep;73:82-92. doi: 10.1016/j.sleep.2020.04.024. Epub 2020 May 7.
- Derived from this study: PubMed 31992407Cheng P, Kalmbach D, Fellman-Couture C, Arnedt JT, Cuamatzi-Castelan A, Drake CL. Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial. J Clin Sleep Med. 2020 Feb 15;16(2):193-198. doi: 10.5664/jcsm.8164. Epub 2020 Jan 13.
- Derived from this study: PubMed 31383238Kalmbach DA, Cheng P, Arnedt JT, Cuamatzi-Castelan A, Atkinson RL, Fellman-Couture C, Roehrs T, Drake CL. Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education. J Clin Sleep Med. 2019 Jul 15;15(7):999-1010. doi: 10.5664/jcsm.7882.
- Derived from this study: PubMed 30785053Kalmbach DA, Cheng P, Arnedt JT, Anderson JR, Roth T, Fellman-Couture C, Williams RA, Drake CL. Treating insomnia improves depression, maladaptive thinking, and hyperarousal in postmenopausal women: comparing cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy, and sleep hygiene education. Sleep Med. 2019 Mar;55:124-134. doi: 10.1016/j.sleep.2018.11.019. Epub 2018 Dec 28.
- Derived from this study: PubMed 30481333Drake CL, Kalmbach DA, Arnedt JT, Cheng P, Tonnu CV, Cuamatzi-Castelan A, Fellman-Couture C. Treating chronic insomnia in postmenopausal women: a randomized clinical trial comparing cognitive-behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education. Sleep. 2019 Feb 1;42(2):zsy217. doi: 10.1093/sleep/zsy217.
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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.
Christopher Drake, PhD principal investigator
Henry Ford Health System
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 for Insomnia, Sleep Education and Sleep Restriction Therapy in people with Menopause, run by Christopher Drake 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 1 inclusion and 1 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 Feb 2023. 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. 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?
Yes. Results are posted in the registry (first posted 22 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diary Based Sleepiness (time frame: 8 months). 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 NCT01933295, which also lists 5 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 Feb 2023.