NCT03596879

Brief Summary

The primary objective of the proposed research is to determine whether prenatal insomnia and ruminative thinking predict severity of postpartum depression (PPD) symptoms. Additionally, the investigators will also determine the effectiveness of digital/internet-based Cognitive Behavioral Therapy for Insomnia (dCBTI) in reducing the risk for PPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

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

First Submitted

Initial submission to the registry

June 8, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

June 8, 2018

Last Update Submit

December 4, 2019

Conditions

InsomniaPost Partum Depression

Keywords

insomniapost partum depression (PPD)digital CBTI (dCBTI)online CBTIrumination

Outcome Measures

Primary Outcomes (2)

  • Improvement in Sleep - Insomnia Severity Index

    The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia.

    Year 1

  • Prevention of Postpartum Depression Symptoms - Edinburg Postnatal Depression Scale (EPDS)

    The Edinburgh Postnatal Depression (EPDS) is the most widely used depression measure in both pregnant and postnatal women. It is validated for use in community samples and clinical trials. The EPDS scores range from 0-30, with a higher score indicating a greater severity of depression.

    Year 1

Study Arms (2)

dCBTI

EXPERIMENTAL

Online access to the digital CBTI program Sleepio.

Behavioral: dCBTI

Sleep Education

PLACEBO COMPARATOR

Weekly email messages with sleep hygiene recommendations.

Behavioral: Sleep Education

Interventions

dCBTIBEHAVIORAL

Online access to the digital CBTI program Sleepio based off of traditional face-to-face Cognitive Behavioral Therapy, six weekly sessions done online.

dCBTI
Sleep EducationBEHAVIORAL

Six weekly email messages with sleep hygiene recommendations. Subjects are encouraged to read through the information and apply it to their sleep.

Sleep Education

Eligibility Criteria

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

You may qualify if:

  • Must be entering their 3rd trimester of pregnancy
  • Must deny any concerns or indications of a high risk pregnancy associated with increased risk for the mother or fetus for negative health outcomes

You may not qualify if:

  • Age \< 18 years old
  • Bipolar or seizure disorders (due to risk in CBTI)
  • Known sleep disorders other than insomnia (eg narcolepsy, restless legs syndrome, obstructive sleep apnea)
  • Women already in their 3rd trimester
  • Women who are not pregnant
  • Women with high risk pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Medical Center

Novi, Michigan, 48377, United States

Location

Related Publications (3)

  • Kalmbach DA, Cheng P, Roth T, Swanson LM, Cuamatzi-Castelan A, Roth A, Drake CL. Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy. Behav Sleep Med. 2022 Mar-Apr;20(2):143-163. doi: 10.1080/15402002.2021.1895793. Epub 2021 Mar 15.

    PMID: 33719795DERIVED

  • Kalmbach DA, Cheng P, O'Brien LM, Swanson LM, Sangha R, Sen S, Guille C, Cuamatzi-Castelan A, Henry AL, Roth T, Drake CL. A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women. Sleep Med. 2020 Aug;72:82-92. doi: 10.1016/j.sleep.2020.03.016. Epub 2020 Mar 21.

    PMID: 32559716DERIVED

  • Kalmbach DA, Cheng P, Ong JC, Ciesla JA, Kingsberg SA, Sangha R, Swanson LM, O'Brien LM, Roth T, Drake CL. Depression and suicidal ideation in pregnancy: exploring relationships with insomnia, short sleep, and nocturnal rumination. Sleep Med. 2020 Jan;65:62-73. doi: 10.1016/j.sleep.2019.07.010. Epub 2019 Jul 22.

    PMID: 31710876DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepression, PostpartumRumination Syndrome

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bioscientific Staff Researcher

Study Record Dates

First Submitted

June 8, 2018

First Posted

July 24, 2018

Study Start

July 18, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

December 5, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)