Behavioral Strategies to Improve Sleep for Expectant Mothers

Overseen By Katherine M Sharkey, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Perinatal sleep certification, No longitudinal client relationship, Infants not living at home, Nighttime caregiver

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve sleep for expectant and new parents through a behavioral sleep program called the Behavioral Sleep Intervention. Participants will use short videos and an app to learn strategies for better sleep. The trial targets individuals who are currently pregnant or have given birth within the last year and are experiencing significant sleep issues. It suits those receiving support from specific healthcare workers and who have a smartphone to access the materials. As an unphased trial, participants can benefit from innovative strategies to enhance sleep quality.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a behavioral sleep intervention, so it's best to discuss your medications with the trial team.

What prior data suggests that this behavioral sleep intervention is safe for expectant mothers?

Research has shown that sleep treatments such as cognitive behavioral therapy for insomnia (CBT-I) are safe for pregnant women. Studies have found that this method improves sleep without significant side effects. Specifically, digital CBT-I has proven effective and well-tolerated by pregnant women, reducing insomnia symptoms without major issues. This suggests that a sleep treatment like the one in this study is likely safe and can improve sleep during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Sleep Intervention for expectant mothers because it offers a fresh approach to managing sleep issues during pregnancy. Unlike standard treatments that might involve medication or general sleep hygiene advice, this method emphasizes personalized behavioral strategies delivered through educational materials and support from trained home visitors. This approach is tailored to the unique needs of expectant and new parents and leverages the convenience of smartphone technology for accessing resources and tracking progress. By focusing on behavioral changes and providing continuous support, this intervention aims to improve sleep quality without the side effects associated with medication.

What evidence suggests that this behavioral sleep intervention is effective for improving sleep in expectant mothers?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I), offered in this trial as a Behavioral Sleep Intervention, can improve sleep for pregnant and new mothers. Studies have found that digital CBT-I reduces insomnia symptoms and enhances sleep quality. Pregnant women who tried CBT-I reported feeling more rested and experiencing fewer sleep problems. Although researchers continue to explore the long-term effects, CBT-I is considered a promising method for addressing sleep issues during and after pregnancy. Overall, this therapy has demonstrated short-term success in helping expectant and new mothers sleep better. ^{1 6 7 8 9}

Who Is on the Research Team?

Katherine M Sharkey, MD, PhD

Principal Investigator

Rhode Island Hospital

Are You a Good Fit for This Trial?

This trial is for expectant and new mothers experiencing sleep issues, including insomnia and disrupted sleep patterns. It aims to help those at risk of postpartum depression linked to poor sleep. Participants should be receiving care from direct care workers who will deliver the intervention.

Inclusion Criteria

I am over 18 years old.

Participants must be working with expectant and new mothers in a community setting

Participants must be receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1

Exclusion Criteria

Participants who already have certification or a specialty in perinatal sleep

Participants who do not have longitudinal relationships with clients

Participants whose infants will not be living in the home or who will have a nighttime caregiver

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Refinement

Development and refinement of the sleep intervention with input from direct care workers

6 months

Ongoing collaboration with direct care workers

Training

Direct care workers are trained to deliver the sleep intervention

1 month

Training sessions

Implementation

Direct care workers deploy the intervention to expectant mothers with sleep concerns

6 months

Regular check-ins with participants

Follow-up

Participants are monitored for effectiveness and acceptability of the intervention

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Sleep Intervention

Trial Overview

The study tests a behavioral sleep intervention using short videos alongside a free app designed to improve sleep hygiene in perinatal women. The effectiveness of this training provided by direct care workers will be evaluated.

How Is the Trial Designed?

Group I: Home Visitors Experimental Treatment 1 Intervention

The participants in Phase 1 of the proposed study are individuals who provide services to perinatal women who are at risk of postpartum depression. The investigators will recruit 35 adults ages 18 years or older who provide health, well-being, and/or mental health services/treatment to pregnant and postpartum women to participate in Phase 1 of this study. Job titles that meet inclusion criteria include nurses, nurse practitioners, family support workers, therapists, counselors, doulas, lactation consultants, childbirth educators, social workers, public health workers, midwives, and nurse midwives. The investigators will not select participants based on age, gender, sex, or racial or ethnic identity.

Group II: Expectant and New Parents Experimental Treatment 1 Intervention

Phase 2 participants will be given access to the educational materials about sleep and the investigators will collect information about their sleep. To qualify for enrollment, Phase 2 participants must be: * expectant parents OR new parents up to 1 year postpartum * 18 to 45 years old * receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1 * speak and read English or Spanish * have access to a smart phone to view the training videos and complete the sleep diaries and assessments * are experiencing clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7 The investigators will exclude potential participants who are parents whose infants will not be living in the home or who will have a nighttime caregiver

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Bradley Hospital

Collaborator

Trials

22

Recruited

1,900+

Published Research Related to This Trial

A modified cognitive-behavioral therapy for insomnia showed promising preliminary efficacy in improving sleep and mood among postpartum women with insomnia and depression, based on an open pilot study with 12 participants.

Participants experienced significant improvements in sleep efficiency, total wake time, mood, insomnia severity, sleep quality, and fatigue after five weekly treatment sessions, suggesting that this therapy could be beneficial for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open pilot of cognitive-behavioral therapy for insomnia in women with postpartum depression. Swanson, LM., Flynn, H., Adams-Mundy, JD., et al.[2018]

Cognitive behavioral therapy for insomnia (CBTi) is a highly effective non-drug treatment for insomnia, showing comparable efficacy to sleep medications in randomized control trials, with better long-term maintenance of benefits after treatment ends.

Due to its strong empirical support, both the National Institutes of Health and the American Academy of Sleep Medicine recommend CBTi as the standard treatment for insomnia, highlighting its importance in addressing the public health burden of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. Siebern, AT., Manber, R.[2018]

In a study of 46 pregnant women with insomnia, residual cognitive arousal after cognitive-behavioral therapy for insomnia (CBTI) was identified as the main factor linked to poor treatment response, suggesting that addressing this issue could improve outcomes.

Patient feedback highlighted the need for insomnia therapy to be tailored to the unique challenges of pregnancy and postpartum, with requests for education on maternal and infant sleep and more flexible behavioral strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy. Kalmbach, DA., Cheng, P., Roth, T., et al.[2023]

The study involves 114 first-time mothers experiencing insomnia symptoms during pregnancy, testing two interventions: a responsive bassinet to improve infant sleep and cognitive behavioral therapy to address maternal sleep-related thoughts and behaviors.

The goal is to determine if these targeted interventions can effectively reduce postpartum insomnia symptoms and improve overall maternal wellbeing, potentially leading to better outcomes for both mothers and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing postpartum insomnia by targeting maternal versus infant sleep: a protocol for a randomized controlled trial (the Study for Mother-Infant Sleep "SMILE"). Quin, N., Tikotzky, L., Stafford, L., et al.[2023]

This randomized controlled trial involves 90 first-time mothers experiencing insomnia symptoms postpartum, aiming to evaluate the effectiveness of Cognitive Behavioural Therapy (CBT) and Light Dark Therapy (LDT) in improving insomnia and related issues like mood and fatigue.

If effective, these interventions could provide safe, cost-effective solutions for postpartum insomnia, potentially enhancing maternal well-being and being easily integrated into standard postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy and Light Dark Therapy for Maternal Postpartum Insomnia Symptoms: Protocol of a Parallel-Group Randomised Controlled Efficacy Trial. Verma, S., Rajaratnam, SMW., Davey, M., et al.[2021]

This study evaluates a scalable cognitive behavioral therapy (CBT) intervention aimed at improving sleep quality in pregnant women and new mothers, addressing a common issue linked to mood disturbances and chronic insomnia.

Conducted as a randomized controlled trial with nulliparous women from the third trimester to 6 months postpartum, the study measures various outcomes related to sleep and well-being at multiple time points, highlighting its potential for integration into routine perinatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scalable cognitive behavioural program to promote healthy sleep during pregnancy and postpartum periods: protocol of a randomised controlled trial (the SEED project). Bei, B., Pinnington, DM., Shen, L., et al.[2020]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia severity and sleep quality in pregnant women, with high-quality evidence showing immediate benefits after the intervention and moderate benefits at short-term follow-up (up to 6 months).

However, the long-term effectiveness of CBT-I remains uncertain, as only one study reported reduced insomnia severity beyond 12 months, indicating a need for more rigorous trials with extended follow-up periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive insight on cognitive behavioral therapy for insomnia in pregnant women: A systematic review and meta-analysis. Shang, X., Ye, L., Wang, MP., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBTI) during pregnancy significantly reduced insomnia severity and wakefulness after sleep onset in postpartum women, particularly for those who responded well to treatment during pregnancy.

Women who received CBTI showed more stable insomnia scores postpartum compared to those in the control group, highlighting the importance of addressing insomnia during pregnancy for better sleep outcomes after childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behavioral therapy for perinatal insomnia: postpartum outcomes. Manber, R., Bei, B., Suh, S., et al.[2023]

A randomized controlled trial involving 62 pregnant women aims to evaluate the effectiveness of a tailored cognitive behavioral therapy for insomnia (CBT-I) in reducing insomnia symptoms and improving maternal and infant health outcomes, including gestational length and depression.

The study will assess the impact of CBT-I delivered either in-person or via telehealth, highlighting its potential to address sleep disturbances during pregnancy, especially during the COVID-19 pandemic, and to minimize risks associated with poor sleep for both mothers and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women. MacKinnon, AL., Madsen, JW., Dhillon, A., et al.[2021]

The Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) program significantly reduced insomnia severity by an average of 10.83 points, leading to an 83.3% remission rate in a trial with 12 pregnant women, indicating its efficacy for treating prenatal insomnia.

PUMAS also effectively decreased symptoms of depression and cognitive arousal, with all five participants with comorbid depression achieving remission, showcasing its potential as a comprehensive treatment for pregnant women experiencing insomnia and related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy. Kalmbach, DA., Cheng, P., Reffi, AN., et al.[2023]

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