InsomniaRESTNCT02805998
Research on Expecting Moms and Sleep Therapy
A study testing Web-based CBT-I and Treatment as Usual in people with Insomnia, run by University of California, San Francisco at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Web-based CBT-I and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to May 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant up to 28 weeks gestation,
- 18 years of age or older,
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia disorder as determined by the Sleep Condition Indicator (SCI) or Insomnia Severity Index (ISI) score ≥ 11
- regular access to a web-enabled computer, tablet, or smart phone.
Who cannot join
- Probable major depression (Edinburgh Postnatal Depression Scale (EPDS) score ≥ 15),
- self-reported bipolar disorder,
- self-reported history of psychosis,
- active suicidality defined as scoring > 1 on EPDS item 10 or report of a specific suicide plan or recent attempt,
- shift work employee,
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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:
- To evaluate feasibility and acceptability of CBT-I for pregnant women.
- To test whether participants receiving CBT-I show improvement in sleep compared to TAU participants.
- To examine whether participants randomized to CBT-I will experience improved depressive outcomes compared to TAU.
- To explore the impact of CBT-I on birth outcomes.
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.
- Conditions
- Insomnia
- Being tested
- Web-based CBT-I, Treatment as Usual
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based CBT-IBehavioural
Treatment as UsualOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Web-based CBT-I; Other: Treatment as Usual |
| 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to post-intervention (10 weeks post-randomization)
Secondary outcomes (5)
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.
Measured: Baseline to post-intervention, an average of 8 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-intervention, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018
- Study completionMay 2019
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 (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer N Felder, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805998
- Sponsor's protocol ID
- 16-19537
- Acronym
- REST
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2016
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 34850238Felder 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.
PubMed 31968068
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Expecting Moms and Sleep Therapy
- ClinicalTrials.gov ID
- NCT02805998
- Acronym / sponsor ID
- REST / 16-19537
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- To evaluate feasibility and acceptability of CBT-I for pregnant women.
- To test whether participants receiving CBT-I show improvement in sleep compared to TAU participants.
- To examine whether participants randomized to CBT-I will experience improved depressive outcomes compared to TAU.
- To explore the impact of CBT-I on birth outcomes.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based CBT-I | Experimental | Behavioral: Web-based CBT-I, Other: Treatment as UsualSleepio 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 | Other: Treatment as UsualOur 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant up to 28 weeks gestation,
- 18 years of age or older,
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia disorder as determined by the Sleep Condition Indicator (SCI) or Insomnia Severity Index (ISI) score ≥ 11
- regular access to a web-enabled computer, tablet, or smart phone.
Key exclusion criteria (5 listed)
- Probable major depression (Edinburgh Postnatal Depression Scale (EPDS) score ≥ 15),
- self-reported bipolar disorder,
- self-reported history of psychosis,
- active suicidality defined as scoring > 1 on EPDS item 10 or report of a specific suicide plan or recent attempt,
- shift work employee,
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 |
|---|---|---|
| Web-based CBT-I | Behavioural | Web-based CBT-I |
| Treatment as Usual | Other | Treatment as Usual, Web-based CBT-I |
Primary outcome
Change in Insomnia Severity Index Scale Score
Time frame: Baseline to post-intervention (10 weeks post-randomization)
Insomnia Severity Index (ISI). Scores on the ISI range from 0 to 28, with higher scores indicating more severe insomnia.
5 secondary outcomes
Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs
Time frame: Baseline to post-intervention, an average of 8 weeks
Change in Sleep Duration, as Determined by Daily Sleep Logs
Time frame: Baseline to post-intervention, an average of 8 weeks
Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score
Time frame: Baseline to post-intervention, an average of 8 weeks
Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score
Time frame: Baseline to post-intervention, an average of 8 weeks
Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator
Time frame: Baseline to post-intervention, an average of 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34850238Felder 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.
- Derived from this study: PubMed 31968068Felder 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.
Related trials for Insomnia
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Active, not recruiting
Innovating CBT-I for Cancer Survivors: An Optimization Trial
Cancer Survivorship, Insomnia
Not yet recruiting
AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
Insomnia
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.
Jennifer N Felder, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based CBT-I and Treatment as Usual in people with Insomnia, run by University of California, San Francisco 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 4 inclusion and 5 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 25 Jun 2024. 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 25 Jun 2024). 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?
Change in Insomnia Severity Index Scale Score (time frame: Baseline to post-intervention (10 weeks post-randomization)). 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 NCT02805998, which also lists 2 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 25 Jun 2024; AzTrials last refreshed its copy on 2 Nov 2026.