Skip to main content
OpenTrials
Completed

NCT Number: NCT03596879

Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insomnia Depression, Postpartum Depressive Disorder Digestive System Diseases Dyssomnias Feeding and Eating Disorders Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Mental Disorders Mood Disorders Nervous System Diseases Post Partum Depression Pregnancy Complications Puerperal Disorders Rumination Syndrome Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Medical Center

Novi, Michigan, 48377, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dCBTI

Behavioral

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

Sleep Education

Behavioral

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study 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

Acronym: PPD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2018
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.