Clinical trial NCT03596879: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Post Partum Depression
Keywords: insomnia
post partum depression (PPD)
digital CBTI (dCBTI)
online CBTI
rumination
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Improvement in Sleep - Insomnia Severity Index
timeFrame: Year 1
measure: Prevention of Postpartum Depression Symptoms - Edinburg Postnatal Depression Scale (EPDS)
timeFrame: Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Medical Center
state: Michigan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.