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

20 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 2 7 9 10}

Research Team

Nalaka S. Gooneratne, MD, MSc

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

I am between 18 and 55 years old.

Has regular access to a smartphone and/or smart tablet

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Sleeping for Two: An Open-Pilot Study of Cognitive Behavioral Therapy for Insomnia in Pregnancy. [2018]

2. 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]

3. 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]

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

Cognitive Behavioral Therapy for Prenatal Insomnia: A Randomized Controlled Trial. [2021]

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

Daytime napping and nighttime sleep in pregnant individuals with insomnia disorder. [2023]

6. 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]

7. 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]

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

Sleep Pharmacotherapy for Common Sleep Disorders in Pregnancy and Lactation. [2021]

9. 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]

10. England 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. [2023]