InsomniaPPDNCT03596879
Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression
A study testing dCBTI and Sleep Education in people with Insomnia and Post Partum Depression, run by Henry Ford Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia, Post Partum Depression
- What is being tested?
- dCBTI and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Insomnia, Post Partum Depression
- Being tested
- dCBTI, Sleep Education
- Keywords
- insomnia, post partum depression (PPD), digital CBTI (dCBTI), online CBTI, rumination
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Postpartum, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dCBTIBehavioural
Online access to the digital CBTI program Sleepio based off of traditional face-to-face Cognitive Behavioral Therapy, six weekly sessions done online.
Sleep EducationBehavioural
Six weekly email messages with sleep hygiene recommendations. Subjects are encouraged to read through the information and apply it to their sleep.
| Study group | Role | What they receive |
|---|---|---|
| dCBTI | Experimental | Online access to the digital CBTI program Sleepio. Receives: Behavioral: dCBTI |
| Sleep Education | Placebo comparator | Weekly email messages with sleep hygiene recommendations. Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start18 Jul 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kalmbach, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596879
- Sponsor's protocol ID
- 12204
- Acronym
- PPD
- Status last verified
- Dec 2019
- First submitted
- 8 Jun 2018
- Last updated
- 5 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33719795Kalmbach 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.
PubMed 32559716Kalmbach 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.
PubMed 31710876
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03596879
- Acronym / sponsor ID
- PPD / 12204
- Conditions
- Insomnia, Post Partum Depression
- Keywords
- insomnia, post partum depression (PPD), digital CBTI (dCBTI), online CBTI, rumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dCBTI | Experimental | Behavioral: dCBTIOnline access to the digital CBTI program Sleepio. |
| Sleep Education | Placebo comparator | Behavioral: Sleep EducationWeekly email messages with sleep hygiene recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dCBTIOnline access to the digital CBTI program Sleepio based off of traditional face-to-face Cognitive Behavioral Therapy, six weekly sessions done online. | Behavioural | dCBTI |
| Sleep EducationSix weekly email messages with sleep hygiene recommendations. Subjects are encouraged to read through the information and apply it to their sleep. | Behavioural | Sleep Education |
Primary outcome
Improvement in Sleep - Insomnia Severity Index
Time frame: Year 1
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.
Prevention of Postpartum Depression Symptoms - Edinburg Postnatal Depression Scale (EPDS)
Time frame: Year 1
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Derived from this study: PubMed 33719795Kalmbach 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.
- Derived from this study: PubMed 32559716Kalmbach 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.
- Derived from this study: PubMed 31710876Kalmbach 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dCBTI and Sleep Education in people with Insomnia and Post Partum Depression, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Sleep - Insomnia Severity Index (time frame: Year 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596879, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.