Treatment for Insomnia During Pregnancy

NCT ID: NCT01846585

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ABTI

Arousal Based Therapy for Insomnia

Group Type OTHER

Arousal Based Therapy for Insomnia

Intervention Type BEHAVIORAL

Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal

CBTI

Cognitive Behavioral Therapy for Insomnia

Group Type OTHER

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep

Interventions

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Arousal Based Therapy for Insomnia

Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Rachel Manber

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Manber, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37078188 (View on PubMed)

Badon 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.

Reference Type DERIVED
PMID: 36448328 (View on PubMed)

King 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.

Reference Type DERIVED
PMID: 31734620 (View on PubMed)

Manber 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.

Reference Type DERIVED
PMID: 30969203 (View on PubMed)

Other Identifiers

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R01NR013662-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23501

Identifier Type: -

Identifier Source: org_study_id

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