## Protocol Section
### Identification Module
**NCT ID:** NCT03596879

**Acronym:** PPD

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 12204
#### Organization
**Class:** OTHER
**Full Name:** Henry Ford Health System
### Status Module
#### Completion Date
**Date:** 2019-07-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-12-05

**Type:** ACTUAL

**Last Update Submit Date:** 2019-12-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-07-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-07-18

**Type:** ACTUAL

**Status Verified Date:** 2019-12

#### Study First Post Date
**Date:** 2018-07-24
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-08
**Study First Submit QC Date:** 2018-07-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Henry Ford Health System

#### Responsible Party

**Investigator Affiliation:** Henry Ford Health System

**Investigator Full Name:** David Kalmbach

**Investigator Title:** Bioscientific Staff Researcher

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Insomnia

- Post Partum Depression

**Keywords:**

- insomnia

- post partum depression (PPD)

- digital CBTI (dCBTI)

- online CBTI

- rumination

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 91

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Online access to the digital CBTI program Sleepio.

**Intervention Names:**

- Behavioral: dCBTI

**Label:** dCBTI

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Weekly email messages with sleep hygiene recommendations.

**Intervention Names:**

- Behavioral: Sleep Education

**Label:** Sleep Education

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- dCBTI

**Description:** Online access to the digital CBTI program Sleepio based off of traditional face-to-face Cognitive Behavioral Therapy, six weekly sessions done online.

**Name:** dCBTI

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Sleep Education

**Description:** Six weekly email messages with sleep hygiene recommendations. Subjects are encouraged to read through the information and apply it to their sleep.

**Name:** Sleep Education

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Improvement in Sleep - Insomnia Severity Index

**Time Frame:** Year 1

**Description:** 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.

**Measure:** Prevention of Postpartum Depression Symptoms - Edinburg Postnatal Depression Scale (EPDS)

**Time Frame:** Year 1

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Novi

**Country:** United States

**Facility:** Henry Ford Medical Center

**State:** Michigan

**Zip:** 48377

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 33719795

**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.

**PMID:** 32559716

**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.

**PMID:** 31710876

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000011644

- Term: Puerperal Disorders

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000001068

- Term: Feeding and Eating Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M21076

- Name: Depression, Postpartum

- Relevance: HIGH

- As Found: Post Partum Depression

- ID: M2062

- Name: Rumination Syndrome

- Relevance: HIGH

- As Found: Rumination

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10356

- Name: Sleep Initiation and Maintenance Disorders

- Relevance: HIGH

- As Found: Insomnia

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14499

- Name: Puerperal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4380

- Name: Feeding and Eating Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T5077

- Name: Rumination Disorder

- Relevance: HIGH

- As Found: Rumination

### Condition Browse Module - Meshes

- ID: D000079562

- Term: Rumination Syndrome

- ID: D000007319

- Term: Sleep Initiation and Maintenance Disorders

- ID: D000019052

- Term: Depression, Postpartum

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-24
