Sleep Initiation and Maintenance DisordersNCT01846585
Treatment for Insomnia During Pregnancy
A study testing Arousal Based Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders, run by Stanford University at 1 site in United States.
Trial summary
The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Arousal Based Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month)
- Pregnant with gestational age between 18-32 weeks.
- Adequately fluent in English or Spanish.
Who cannot join
- Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea)
- Co-morbid psychiatric disorder
- Use of medications, herbs or other drugs with known effects on sleep
- Unstable medical conditions
- Currently engaged in psychotherapy or other treatments for insomnia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Non-Pharmacological Treatment for Insomnia During Pregnancy
The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.
- Being tested
- Arousal Based Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia
- 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.
Arousal Based Therapy for InsomniaBehavioural
Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal
Cognitive Behavioral Therapy for InsomniaBehavioural
Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
| Study group | Role | What they receive |
|---|---|---|
| ABTI | Other | Arousal Based Therapy for Insomnia Receives: Behavioral: Arousal Based Therapy for Insomnia |
| CBTI | Other | Cognitive Behavioral Therapy for Insomnia Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of insomnia remission
Measured: Baseline to 30 weeks postpartum
Secondary outcomes (3)
Insomnia severity
Measured: Baseline to 30 weeks postpartum
Depression severity
Measured: Baseline to 30 weeks postpartum
Sleep Characteristics
Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration.
Measured: Baseline to 30 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Rachel Manber, Stanford University
- Investigators
- Rachel Manber, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846585
- Sponsor's protocol ID
- 23501
- Other IDs
- R01NR013662-01
- Status last verified
- Jul 2018
- First submitted
- 30 Apr 2013
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manber R, Bei B, Suh S, Simpson N, Rangel E, Sit A, Lyell DJ. Randomized controlled trial of cognitive behavioral therapy for perinatal insomnia: postpartum outcomes. J Clin Sleep Med. 2023 Aug 1;19(8):1411-1419. doi: 10.5664/jcsm.10572.
PubMed 37078188Badon SE, Dietch JR, Simpson N, Lyell DJ, Manber R. Daytime napping and nighttime sleep in pregnant individuals with insomnia disorder. J Clin Sleep Med. 2023 Feb 1;19(2):371-377. doi: 10.5664/jcsm.10350.
PubMed 36448328King LS, Rangel E, Simpson N, Tikotzky L, Manber R. Mothers' postpartum sleep disturbance is associated with the ability to sustain sensitivity toward infants. Sleep Med. 2020 Jan;65:74-83. doi: 10.1016/j.sleep.2019.07.017. Epub 2019 Jul 27.
PubMed 31734620Manber R, Bei B, Simpson N, Asarnow L, Rangel E, Sit A, Lyell D. Cognitive Behavioral Therapy for Prenatal Insomnia: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):911-919. doi: 10.1097/AOG.0000000000003216.
PubMed 30969203
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Non-Pharmacological Treatment for Insomnia During Pregnancy
- ClinicalTrials.gov ID
- NCT01846585
- Acronym / sponsor ID
- 23501
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Apr 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 3 May 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.
The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABTI | Other | Behavioral: Arousal Based Therapy for InsomniaArousal Based Therapy for Insomnia |
| CBTI | Other | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month)
- Pregnant with gestational age between 18-32 weeks.
- Adequately fluent in English or Spanish.
Key exclusion criteria (5 listed)
- Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea)
- Co-morbid psychiatric disorder
- Use of medications, herbs or other drugs with known effects on sleep
- Unstable medical conditions
- Currently engaged in psychotherapy or other treatments for insomnia
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 |
|---|---|---|
| Arousal Based Therapy for InsomniaIntervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal | Behavioural | ABTI |
| Cognitive Behavioral Therapy for InsomniaIntervention includes education about sleep and behavioral and cognitive strategies to improve sleep | Behavioural | CBTI |
Primary outcome
Rate of insomnia remission
Time frame: Baseline to 30 weeks postpartum
3 secondary outcomes
Insomnia severity
Time frame: Baseline to 30 weeks postpartum
Depression severity
Time frame: Baseline to 30 weeks postpartum
Sleep Characteristics
Time frame: Baseline to 30 weeks postpartum
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 23 Jul 2018.
- Derived from this study: PubMed 37078188Manber R, Bei B, Suh S, Simpson N, Rangel E, Sit A, Lyell DJ. Randomized controlled trial of cognitive behavioral therapy for perinatal insomnia: postpartum outcomes. J Clin Sleep Med. 2023 Aug 1;19(8):1411-1419. doi: 10.5664/jcsm.10572.
- Derived from this study: PubMed 36448328Badon SE, Dietch JR, Simpson N, Lyell DJ, Manber R. Daytime napping and nighttime sleep in pregnant individuals with insomnia disorder. J Clin Sleep Med. 2023 Feb 1;19(2):371-377. doi: 10.5664/jcsm.10350.
- Derived from this study: PubMed 31734620King LS, Rangel E, Simpson N, Tikotzky L, Manber R. Mothers' postpartum sleep disturbance is associated with the ability to sustain sensitivity toward infants. Sleep Med. 2020 Jan;65:74-83. doi: 10.1016/j.sleep.2019.07.017. Epub 2019 Jul 27.
- Derived from this study: PubMed 30969203Manber R, Bei B, Simpson N, Asarnow L, Rangel E, Sit A, Lyell D. Cognitive Behavioral Therapy for Prenatal Insomnia: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):911-919. doi: 10.1097/AOG.0000000000003216.
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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.
Rachel Manber, Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arousal Based Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders, run by Stanford University 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 3 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 23 Jul 2018. 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?
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?
Rate of insomnia remission (time frame: Baseline to 30 weeks postpartum). 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 NCT01846585, which also lists 4 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 23 Jul 2018.