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Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression (PPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596879
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
David Kalmbach, Henry Ford Health System

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.

Condition or disease Intervention/treatment Phase
Insomnia Post Partum Depression Behavioral: dCBTI Behavioral: Sleep Education Not Applicable

Detailed Description:

The purpose of this study is to 1) explore the relationship between prenatal insomnia, ruminative thinking and the severity of PPD symptoms. and 2) determine the effectiveness of Digital Cognitive Behavioral Therapy (dCBTI) in reducing the risk for postpartum depression in pregnant mothers entering into their third trimester. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) that is used with people who experience trouble sleeping at night (insomniacs). As pregnant women are especially vulnerable to sleep problems during this period, this study will help us determine whether dCBTI is helpful in improving sleep and reducing the risk for PPD in this population.

Pregnant women entering their third trimester will be recruited from the Henry Ford Health System through the HFHS Electronic Medical Record (EPIC). They will receive an email from study personnel describing the study, and encouraged to schedule a phone call to discuss study details. Participants will then complete a consent and an online screening survey. Upon meeting inclusion criteria, participants will complete weekly surveys and randomized into one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete.

Subjects will complete weekly online surveys beginning at week 30 of pregnancy, and continuing through 6 weeks after giving birth.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insomnia and Rumination in Late-pregnancy and the Risk for Postpartum Depression (PPD): A Randomized Controlled Trial of Online Cognitive Behavioral Therapy for Insomnia to Prevent PPD
Actual Study Start Date : July 18, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dCBTI
Online access to the digital CBTI program Sleepio.
Behavioral: dCBTI
Online access to the digital CBTI program Sleepio based off of traditional face-to-face Cognitive Behavioral Therapy, six weekly sessions done online.

Placebo Comparator: Sleep Education
Weekly email messages with sleep hygiene recommendations.
Behavioral: Sleep Education
Six weekly email messages with sleep hygiene recommendations. Subjects are encouraged to read through the information and apply it to their sleep.




Primary Outcome Measures :
  1. Improvement in Sleep - Insomnia Severity Index [ Time Frame: Year 1 ]
    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.

  2. Prevention of Postpartum Depression Symptoms - Edinburg Postnatal Depression Scale (EPDS) [ Time Frame: Year 1 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596879


Locations
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United States, Michigan
Henry Ford Medical Center
Novi, Michigan, United States, 48377
Sponsors and Collaborators
Henry Ford Health System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Kalmbach, Bioscientific Staff Researcher, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03596879    
Other Study ID Numbers: 12204
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Kalmbach, Henry Ford Health System:
insomnia
post partum depression (PPD)
digital CBTI (dCBTI)
online CBTI
rumination
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Puerperal Disorders
Pregnancy Complications