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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dCBTI | Experimental | Online access to the digital CBTI program Sleepio. |
|
| Sleep Education | Placebo Comparator | Weekly email messages with sleep hygiene recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Medical Center | Novi | Michigan | 48377 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33719795 | Derived | 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. | |
| 32559716 |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D019052 | Depression, Postpartum |
| D000079562 | Rumination Syndrome |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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. |
|
| 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. |
| 31710876 | Derived | 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. |
| D001523 |
| Mental Disorders |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |