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

Insomnia Clinical Trial

— PPD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596879
• Other study ID #: 12204
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2019
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Insomnia
• Post Partum Depression
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Henry Ford Medical Center	Novi	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Sleep - Insomnia Severity Index	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.	Year 1
Primary	Prevention of Postpartum Depression Symptoms - Edinburg Postnatal Depression Scale (EPDS)	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.	Year 1