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The overarching goal is to utilize a randomized control design to examine efficacy of web-based cognitive behavior therapy (CBT-I) plus treatment as usual compared to treatment as usual alone for insomnia and depression outcomes among pregnant women with insomnia at high risk for depressive relapse/recurrence (n=208).
Depression in pregnancy ("antenatal depression") is common and associated with acute and long-lasting adverse consequences for women and offspring. Insomnia is a risk factor for depression in general populations, and poor sleep quality is linked to increased depression among antenatal women. There have been no randomized control trials investigating nonpharmacological insomnia treatment on antenatal insomnia and depression outcomes. Many pregnant women use the Internet to seek pregnancy-related information, and report a preference for mental health care within the home or obstetrics clinic. The overarching goal is to utilize a randomized control design to examine efficacy of web-based cognitive behavior therapy for insomnia and depression outcomes (CBT-I) compared to treatment as usual (TAU) among pregnant women at risk for depression (n=208). Participants will be recruited nationally to complete study questionnaires at five timepoints through pregnancy and 6 months postpartum. Participants randomized to CBT-I will receive access to 6 weekly CBT-I web-sessions and treatment as usual. Participants randomized to treatment as usual will receive usual care and will be given access to Sleepio upon study completion. Our specific aims are:
There is strong conceptual basis to predict the potential benefit of this approach for pregnant women. Targeting risk factors for antenatal depression may have significant public health benefits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based CBT-I | Experimental | Sleepio delivers CBT-I through 6 weekly web-sessions. Treatment content is based on CBT for insomnia manuals and includes a behavioral component (sleep restriction, stimulus control, and relaxation), a cognitive component (paradoxical intention, cognitive restructuring, mindfulness, positive imagery, putting the day to rest) and an educational component (psycho-education, sleep hygiene). |
|
| Treatment as Usual | Other | Our control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy. Use of non-study treatment will be tracked. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based CBT-I | Behavioral |
| ||
| Treatment as Usual |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity Index Scale Score | Insomnia Severity Index (ISI). Scores on the ISI range from 0 to 28, with higher scores indicating more severe insomnia. | Baseline to post-intervention (10 weeks post-randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs | Daily sleep diaries were used to measure percentage of sleep efficiency. Percentage of sleep efficiency was calculated by dividing the amount of time sleeping by the amount of time spent in bed. Sleep efficiency ranges from 0 to 100 percent, with higher scores indicating better outcomes. | Baseline to post-intervention, an average of 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer N Felder, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34850238 | Derived | Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Randomized controlled trial of digital cognitive behavior therapy for prenatal insomnia symptoms: effects on postpartum insomnia and mental health. Sleep. 2022 Feb 14;45(2):zsab280. doi: 10.1093/sleep/zsab280. | |
| 31968068 | Derived | Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):484-492. doi: 10.1001/jamapsychiatry.2019.4491. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Web-based CBT-I | Sleepio delivers cognitive behavior therapy for insomnia (CBT-I) through 6 weekly web-sessions. Treatment content is based on CBT for insomnia manuals and includes a behavioral component (sleep restriction, stimulus control, and relaxation), a cognitive component (paradoxical intention, cognitive restructuring, mindfulness, positive imagery, putting the day to rest) and an educational component (psycho-education, sleep hygiene). Web-based CBT-I Treatment as Usual |
| FG001 | Treatment as Usual | Our control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy. Use of non-study treatment will be tracked. Treatment as Usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Web-based CBT-I | Sleepio delivers CBT-I through 6 weekly web-sessions. Treatment content is based on CBT for insomnia manuals and includes a behavioral component (sleep restriction, stimulus control, and relaxation), a cognitive component (paradoxical intention, cognitive restructuring, mindfulness, positive imagery, putting the day to rest) and an educational component (psycho-education, sleep hygiene). Web-based CBT-I Treatment as Usual |
| 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 | Change in Insomnia Severity Index Scale Score | Insomnia Severity Index (ISI). Scores on the ISI range from 0 to 28, with higher scores indicating more severe insomnia. | The number of participants analyzed is fewer than the number of participants who completed each arm of the study due to 23 participants being lost-to-follow up and not completing the ISI at post-intervention. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-intervention (10 weeks post-randomization) |
|
Through 18 weeks after randomization.
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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 | Web-based CBT-I | Sleepio delivers CBT-I through 6 weekly web-sessions. Treatment content is based on CBT for insomnia manuals and includes a behavioral component (sleep restriction, stimulus control, and relaxation), a cognitive component (paradoxical intention, cognitive restructuring, mindfulness, positive imagery, putting the day to rest) and an educational component (psycho-education, sleep hygiene). Web-based CBT-I Treatment as Usual |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Felder | UCSF | 415-476-7014 | jennifer.felder@ucsf.edu |
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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 | Jul 8, 2016 | Apr 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Change in Sleep Duration, as Determined by Daily Sleep Logs | Daily sleep diaries were used to measure sleep duration. Greater sleep duration indicates a better outcome. | Baseline to post-intervention, an average of 8 weeks |
| Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score | Global sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating worse global sleep quality. | Baseline to post-intervention, an average of 8 weeks |
| Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score | Depressive symptom severity was assessed using the Edinburgh Postnatal Depression Scale (EDPS). Scores on the EPDS range from 0 to 30, with higher scores indicating greater depressive symptom severity. | Baseline to post-intervention, an average of 8 weeks |
| Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator | Insomnia caseness (i.e., whether a participant met the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition criteria for insomnia disorder) was assessed by the Sleep Condition Indicator (SCI), which is an eight-item rating scale to screen for an insomnia diagnosis. Scores range 0-32 with higher numbers indicating better sleep quality. Participants who scored below the cutoff were defined as having insomnia caseness (≤16). The mean indicates the direction and magnitude of the preponderance of changes in that direction. That is, negative values of the mean indicate that there were more changes from a baseline SCI value between 17 and 32 to a post-intervention SCI value between 1 and 16 than changes in the other direction. | Baseline to post-intervention, an average of 8 weeks |
| BG001 | Treatment as Usual | Our control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy. Use of non-study treatment will be tracked. Treatment as Usual |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age at screening | Mean | Standard Deviation | weeks |
|
| Income greater than or equal to 100,000 dollars | Count of Participants | Participants |
|
| Married or cohabitating | Count of Participants | Participants |
|
| Primiparous | Count of Participants | Participants |
|
| Insomnia symptom severity | Insomnia Severity Index (ISI). Scores on the ISI range from 0 to 28, with higher scores indicating more severe insomnia. | Mean | Standard Deviation | units on a scale |
|
| Percentage of sleep efficiency | Daily sleep diaries were used to measure sleep efficiency. Sleep efficiency was calculated by dividing the amount of time sleeping by the amount of time spent in bed. Sleep efficiency ranges from 0 to 100 percent, with higher scores indicating better outcomes. | Mean | Standard Deviation | percentage |
|
| Nightly sleep duration | Mean | Standard Deviation | hours |
|
| Global sleep quality | Global sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating worse global sleep quality. | Mean | Standard Deviation | units on a scale |
|
| Insomnia caseness | Insomnia caseness (i.e., whether a participant met the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition criteria for insomnia disorder) was assessed by the Sleep Condition Indicator (SCI), which is an eight-item rating scale to screen for an insomnia diagnosis. Insomnia caseness was determined by a complex scoring algorithm for the SCI. | Count of Participants | Participants |
|
| Depressive symptom severity | Depressive symptom severity was assessed using the Edinburgh Postnatal Depression Scale (EDPS). Scores on the EPDS range from 0 to 30, with higher scores indicating greater depressive symptom severity. | Mean | Standard Deviation | units on a scale |
|
| Anxiety symptom severity | Anxiety symptom severity was assessed using the Generalized Anxiety Disorder Scale-7. Scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Treatment as Usual | Our control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy. Use of non-study treatment will be tracked. Treatment as Usual |
|
|
| Secondary | Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs | Daily sleep diaries were used to measure percentage of sleep efficiency. Percentage of sleep efficiency was calculated by dividing the amount of time sleeping by the amount of time spent in bed. Sleep efficiency ranges from 0 to 100 percent, with higher scores indicating better outcomes. | The number of participants analyzed is fewer than the number of participants who completed each arm of the study due to 34 participants being lost-to-follow up and not completing sleep diaries at post-intervention. | Posted | Mean | Standard Deviation | percentage | Baseline to post-intervention, an average of 8 weeks |
|
|
|
| Secondary | Change in Sleep Duration, as Determined by Daily Sleep Logs | Daily sleep diaries were used to measure sleep duration. Greater sleep duration indicates a better outcome. | The number of participants analyzed is fewer than the number of participants who completed each arm of the study due to 34 participants being lost-to-follow up and not completing sleep diaries at post-intervention. | Posted | Mean | Standard Deviation | hours | Baseline to post-intervention, an average of 8 weeks |
|
|
|
| Secondary | Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score | Global sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating worse global sleep quality. | The number of participants analyzed is fewer than the number of participants who completed each arm of the study due to 27 participants being lost-to-follow up and not completing the PSQI at post-intervention. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-intervention, an average of 8 weeks |
|
|
|
| Secondary | Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score | Depressive symptom severity was assessed using the Edinburgh Postnatal Depression Scale (EDPS). Scores on the EPDS range from 0 to 30, with higher scores indicating greater depressive symptom severity. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-intervention, an average of 8 weeks |
|
|
|
| Secondary | Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator | Insomnia caseness (i.e., whether a participant met the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition criteria for insomnia disorder) was assessed by the Sleep Condition Indicator (SCI), which is an eight-item rating scale to screen for an insomnia diagnosis. Scores range 0-32 with higher numbers indicating better sleep quality. Participants who scored below the cutoff were defined as having insomnia caseness (≤16). The mean indicates the direction and magnitude of the preponderance of changes in that direction. That is, negative values of the mean indicate that there were more changes from a baseline SCI value between 17 and 32 to a post-intervention SCI value between 1 and 16 than changes in the other direction. | The number of participants analyzed is fewer than the number of participants who completed each arm of the study due to 25 participants being lost-to-follow up and not completing the SCI at post-intervention. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-intervention, an average of 8 weeks |
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| 3 |
| 105 |
| EG001 | Treatment as Usual | Our control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy. Use of non-study treatment will be tracked. Treatment as Usual | 0 | 103 | 0 | 103 | 3 | 103 |
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
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| D001523 |
| Mental Disorders |