20 Participants Needed

Assisted Therapy for Pregnancy-Related Insomnia

Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in 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 assisted therapy for pregnancy-related insomnia safe for humans?

Cognitive-behavioral therapy for insomnia (CBT-I), a type of assisted therapy, has been studied in pregnant women and shown to improve sleep and mood without reported safety concerns. Non-drug treatments like CBT-I are generally considered safe during pregnancy.12345

How does the Assisted Therapy for Pregnancy-Related Insomnia treatment differ from other treatments?

Assisted Therapy for Pregnancy-Related Insomnia, which includes sleep hygiene, is unique because it focuses on behavioral strategies to improve sleep without medication, potentially reducing cognitive arousal and enhancing maternal-fetal attachment. This approach is different from traditional treatments like cognitive-behavioral therapy, as it may incorporate mindfulness techniques to address anxiety and repetitive thinking, offering a holistic benefit beyond just improving sleep.24678

What data supports the effectiveness of the treatment Assisted Therapy, Sleep Hygiene for pregnancy-related insomnia?

Research shows that cognitive behavioral therapy for insomnia (CBT-I), which is similar to assisted therapy, can significantly improve sleep quality and reduce insomnia symptoms in pregnant women. Studies have found that CBT-I leads to better sleep efficiency and reduced symptoms of depression and anxiety during pregnancy.128910

Who Is on the Research Team?

NG

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.
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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?
2Treatment groups
Experimental Treatment
Active Control
Group I: ART and Sleep HygieneExperimental Treatment2 Interventions
Group II: Sleep HygieneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Published Research Related to This Trial

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.
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]
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.
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]
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.
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]

Citations

Sleeping for Two: An Open-Pilot Study of Cognitive Behavioral Therapy for Insomnia in Pregnancy. [2018]
A comprehensive insight on cognitive behavioral therapy for insomnia in pregnant women: A systematic review and meta-analysis. [2023]
Preventing postpartum insomnia by targeting maternal versus infant sleep: a protocol for a randomized controlled trial (the Study for Mother-Infant Sleep "SMILE"). [2023]
Cognitive Behavioral Therapy for Prenatal Insomnia: A Randomized Controlled Trial. [2021]
Daytime napping and nighttime sleep in pregnant individuals with insomnia disorder. [2023]
Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy. [2023]
Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women. [2021]
Sleep Pharmacotherapy for Common Sleep Disorders in Pregnancy and Lactation. [2021]
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]
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. [2023]
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