Behavioral Strategies to Improve Sleep for Expectant Mothers

Recruiting in Palo Alto (17 mi)

Overseen by Katherine M Sharkey, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rhode Island Hospital

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

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app. In Phase 1, the investigators will develop and refine the intervention with input from direct care workers who serve at-risk perinatal women. In Phase 2, direct care workers will deploy the training to expectant mothers with sleep concerns and the investigators will assess the reach, effectiveness, adoption, implementation, and maintenance of this scalable, efficient intervention to improve sleep.

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 data supports the effectiveness of the treatment Behavioral Sleep Intervention, Sleep Therapy, Cognitive Behavioral Therapy for Insomnia (CBT-I), Behavioral Sleep Medicine for expectant mothers?

Research suggests that Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep and mood in pregnant women, although its effectiveness may vary compared to the general population. Additionally, therapies that reduce cognitive arousal, such as mindfulness-based interventions, may enhance outcomes for pregnant women with insomnia. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for expectant mothers?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe for expectant mothers, as it is a non-drug treatment that focuses on changing sleep habits and behaviors. It is recommended by health organizations as a standard treatment for insomnia, with no significant safety concerns reported in the research. ^{1 3 6 7 8}

How is the Behavioral Sleep Intervention treatment different from other treatments for insomnia in expectant mothers?

The Behavioral Sleep Intervention, specifically Cognitive Behavioral Therapy for Insomnia (CBT-I), is unique because it focuses on changing unhelpful thoughts and behaviors related to sleep, rather than using medication. This approach is particularly beneficial for expectant mothers as it is non-invasive and can be personalized to address specific sleep-related issues during pregnancy. ^{1 5 8 9 10}

Research Team

Katherine M Sharkey, MD, PhD

Principal Investigator

Rhode Island Hospital

Eligibility Criteria

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

I want to offer my clients tools for managing sleep issues during and after pregnancy.

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

Trial Timeline

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

Treatment Details

Interventions

• Behavioral Sleep Intervention (Behavioral 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.

Participant Groups

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+

Sarah Frost

Rhode Island Hospital

Chief Executive Officer

MBA from the University of Phoenix, BSc in Business Administration from the University of Arizona

G. Dean Roye

Rhode Island Hospital

Chief Medical Officer

MD

Bradley Hospital

Collaborator

Trials

22

Recruited

1,900+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A comprehensive insight on cognitive behavioral therapy for insomnia in pregnant women: A systematic review and meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women. [2021]

3. England 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. [2023]

4. Netherlands 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. [2023]

5. Switzerland 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behavioral therapy for perinatal insomnia: postpartum outcomes. [2023]

8. England 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). [2020]

9. United States 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"). [2023]

10. England pubmed.ncbi.nlm.nih.gov

An open pilot of cognitive-behavioral therapy for insomnia in women with postpartum depression. [2018]