Novi, Michigan 48377


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03596879


Primary Contact:

David Kalmbach, PhD
Phone: 248-325-3938
Email: dkalmbach1@hfhs.org


Backup Contact:

Email: cfellma1@hfhs.org
Cynthia Fellman-Couture, RN, PhD
Phone: 248-344-7362


Location Contact:

Novi, Michigan 48377
United States

David Kalmbach, PhD
Phone: 248-325-3938
Email: dkalmbach1@hfhs.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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