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



Status:Recruiting
Conditions:Depression, Depression, Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:8/4/2018
Start Date:July 18, 2018
End Date:October 2019
Contact:David Kalmbach, PhD
Email:dkalmbach1@hfhs.org
Phone:248-325-3938

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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

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.

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.

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
We found this trial at
1
site
39450 West 12 Mile Road
Novi, Michigan 48377
Phone: 248-325-3938
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Novi, MI
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