NCT01846585

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

4.9 years

First QC Date

April 30, 2013

Last Update Submit

July 19, 2018

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

  • Rate of insomnia remission

    Baseline to 30 weeks postpartum

Secondary Outcomes (3)

  • Insomnia severity

    Baseline to 30 weeks postpartum

  • Depression severity

    Baseline to 30 weeks postpartum

  • Sleep Characteristics

    Baseline to 30 weeks postpartum

Study Arms (2)

ABTI

OTHER

Arousal Based Therapy for Insomnia

Behavioral: Arousal Based Therapy for Insomnia

CBTI

OTHER

Cognitive Behavioral Therapy for Insomnia

Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Arousal Based Therapy for InsomniaBEHAVIORAL

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

ABTI
Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

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

CBTI

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Publications (4)

  • 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.

    PMID: 37078188DERIVED

  • 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.

    PMID: 36448328DERIVED

  • 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.

    PMID: 31734620DERIVED

  • 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.

    PMID: 30969203DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rachel Manber, Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 3, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Locations

US(1)