Assisted Therapy for Pregnancy-Related Insomnia

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Night shift work, Blindness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help pregnant women with insomnia using a relaxation technique called Assisted Therapy. The study compares two groups: one learns sleep hygiene (habits for better sleep) and receives additional relaxation training, while the other learns only sleep hygiene. The aim is to determine if the extra training improves sleep. Women in their second or third trimester of pregnancy who have experienced difficulty falling or staying asleep for at least a month may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance sleep health for pregnant women.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that non-drug treatments, such as improving sleep habits and therapy, are generally safe for pregnant women. These methods enhance sleep and reduce stress. For example, one study found that simple actions like listening to music and following sleep tips improved sleep quality and reduced insomnia in pregnant women.

Another study suggested that these methods can be tailored to individual needs, increasing their effectiveness without causing harm. As these treatments do not involve medication, they carry a low risk of side effects. Overall, these behavioral treatments are well-tolerated and offer a safe option for managing insomnia during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Assisted Therapy for pregnancy-related insomnia because it combines behavioral education with personalized techniques that go beyond traditional sleep hygiene practices. Unlike standard treatments that typically focus solely on sleep hygiene tips, this approach aims to provide a more holistic intervention by incorporating assisted therapy, which may address underlying behavioral issues contributing to insomnia. This dual approach could potentially offer more effective and rapid relief for expectant mothers struggling with sleep issues, making it a promising option for improving sleep quality during pregnancy.

What evidence suggests that this trial's treatments could be effective for pregnancy-related insomnia?

Research has shown that good sleep habits and guided relaxation can help pregnant women sleep better and reduce insomnia. An online study found that following sleep tips and listening to music eased insomnia symptoms. These non-drug treatments have improved sleep for expecting mothers. In this trial, one group will receive both Assisted Therapy and Sleep Hygiene education, while another group will receive only Sleep Hygiene education. Additionally, a program called PUMAS lowered insomnia severity by an average of 10.83 points. This evidence suggests that combining relaxation techniques with good sleep habits could effectively manage insomnia during pregnancy. ^{1 2 5 6 7}

Who Is on the Research Team?

Nalaka S. Gooneratne, MD, MSc

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-55 in their second or third trimester, who have trouble falling asleep or staying asleep at least three nights a week for over a month. They must be fluent in English and have access to a smartphone or tablet. Women with night shift work schedules or other medical issues that could interfere with the study can't participate.

Inclusion Criteria

Able to speak, read and write fluent English

Has regular access to a smartphone and/or smart tablet

I have trouble falling asleep or wake up at night for 30 minutes or more, at least 3 nights a week, for over a month.

Exclusion Criteria

Participants with fixed night shift work between midnight and 5 am, or rotating work schedules requiring night shifts during the study period

Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the ART due to blindness)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioral relaxation intervention aimed at improving insomnia symptoms

8 weeks

Weekly sessions

Follow-up

Participants are monitored for sleep quality and adherence to the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Assisted Therapy
• Sleep Hygiene

Trial Overview

The study is testing how well behavioral relaxation techniques help improve sleep in pregnant women with insomnia. It involves learning sleep hygiene practices and participating in assisted therapy using technology like smartphones or tablets.

How Is the Trial Designed?

Group I: ART and Sleep Hygiene Experimental Treatment 2 Interventions

This arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding

Group II: Sleep Hygiene Active Control 1 Intervention

This arm will receive behavioral education, such as sleep hygiene and other advice. Additional details cannot be provided since that will compromise the participant blinding

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

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]

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 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]

The 'Perinatal Understanding of Mindful Awareness for Sleep' (PUMAS) program significantly improved mindfulness and maternal-fetal attachment in 11 pregnant women with insomnia, indicating its potential benefits beyond just sleep improvement.

Participants also experienced substantial reductions in anxiety, repetitive thinking, and sleep-related daytime impairment, suggesting that PUMAS may enhance overall maternal well-being during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evidence of psychological improvements and increased maternal-fetal attachment associated with a mindfulness sleep programme: secondary analysis of uncontrolled data in 11 pregnant women with insomnia disorder. Kalmbach, DA., Reffi, AN., Ong, JC., 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]

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]

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Preventing postpartum insomnia: findings from a three-arm ...

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