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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR013959-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Wayne State University | OTHER |
| University of Michigan | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Education | Active Comparator | Weekly educational emails sent to participants with information about sleep science and tips for better sleep. |
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| Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral treatment (5 component) |
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| Sleep Restriction Therapy | Experimental | Brief sleep restriction therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral |
| ||
| Sleep Education |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Drake, PhD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32799029 | Derived | 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. | |
| 31992407 | Derived | Cheng 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep Education | Weekly educational emails sent to participants with information about sleep science and tips for better sleep. Sleep Education |
| FG001 | Cognitive Behavioral Therapy for Insomnia | Behavioral (sleep restriction and stimulus control) and cognitive (eg, cognitive restructuring) components, as well as relaxation strategies (eg, progressive muscle relaxation and autogenic training) and sleep hygiene education. |
| FG002 | Sleep Restriction Therapy | 2-week intervention. Specifically, the initial face-to-face session consisted of reviewing patient sleep history, education and rationale for sleep restriction practices, and behavioral homework. Then four follow-up sessions (three phone contacts, each 3-4 days apart, followed by a second face-to-face session) were delivered across the following 2 weeks and were used to titrate sleep schedules based on sleep diary data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep Education | Weekly educational emails sent to participants with information about sleep science and tips for better sleep. Sleep Education |
| BG001 | Cognitive Behavioral Therapy for Insomnia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Lost to follow-up at 6 months follow-up assessment | Posted | Mean | Standard Deviation | score on a scale | 8 months |
|
Through study completion, consisting of 8 months of study participation for each participant.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, doesn't differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleep Education | Weekly educational emails sent to participants with information about sleep science and tips for better sleep. Sleep Education |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Drake | Henry Ford Health | (248) 344-6672 | cdrake1@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2017 | Jan 25, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2017 | Dec 15, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral |
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| Sleep Restriction Therapy | Behavioral |
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| 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) |
| 8 months |
| 31383238 | Derived | Kalmbach 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. |
| 30785053 | Derived | Kalmbach 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. |
| 30481333 | Derived | Drake 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. |
Behavioral (sleep restriction and stimulus control) and cognitive (eg, cognitive restructuring) components, as well as relaxation strategies (eg, progressive muscle relaxation and autogenic training) and sleep hygiene education.
| BG002 | Sleep Restriction Therapy | 2-week intervention. Specifically, the initial face-to-face session consisted of reviewing patient sleep history, education and rationale for sleep restriction practices, and behavioral homework. Then four follow-up sessions (three phone contacts, each 3-4 days apart, followed by a second face-to-face session) were delivered across the following 2 weeks and were used to titrate sleep schedules based on sleep diary data. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Behavioral (sleep restriction and stimulus control) and cognitive (eg, cognitive restructuring) components, as well as relaxation strategies (eg, progressive muscle relaxation and autogenic training) and sleep hygiene education. |
| OG002 | Sleep Restriction Therapy | 2-week intervention. Specifically, the initial face-to-face session consisted of reviewing patient sleep history, education and rationale for sleep restriction practices, and behavioral homework. Then four follow-up sessions (three phone contacts, each 3-4 days apart, followed by a second face-to-face session) were delivered across the following 2 weeks and were used to titrate sleep schedules based on sleep diary data. |
|
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| Secondary | 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). | Lost to follow-up at 6 months follow-up assessment | Posted | Mean | Standard Deviation | score on a scale | 8 months |
|
|
|
| Secondary | 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) | Lost to follow-up at 6 months follow-up assessment | Posted | Mean | Standard Deviation | score on a scale | 8 months |
|
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|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Cognitive Behavioral Therapy for Insomnia | Behavioral (sleep restriction and stimulus control) and cognitive (eg, cognitive restructuring) components, as well as relaxation strategies (eg, progressive muscle relaxation and autogenic training) and sleep hygiene education. | 0 | 52 | 0 | 52 | 0 | 52 |
| EG002 | Sleep Restriction Therapy | 2-week intervention. Specifically, the initial face-to-face session consisted of reviewing patient sleep history, education and rationale for sleep restriction practices, and behavioral homework. Then four follow-up sessions (three phone contacts, each 3-4 days apart, followed by a second face-to-face session) were delivered across the following 2 weeks and were used to titrate sleep schedules based on sleep diary data. | 0 | 52 | 0 | 52 | 0 | 52 |
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| Post Treatment |
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| 6 months follow-up |
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| Post-Treatment |
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| 6 months follow-up |
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