Mindfulness-Based Therapy for Pregnancy-Related Insomnia

(INSPIRE Trial)

Overseen By David Kalmbach, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: High risk pregnancy, Night shift, others

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

Compensation: Varies

Number of Visits: 9

Duration: 6-9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two therapies for pregnant women experiencing insomnia and depression. One treatment uses Cognitive Behavioral Therapy for Insomnia (CBTI), which focuses on changing sleep habits and thoughts about sleep. The other, called Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), is a mindfulness-based therapy specifically designed for pregnant women, combining relaxation techniques with sleep strategies. Women between 14 and 31 weeks of a single pregnancy, who have insomnia and depression, and reliable internet access, might be a good fit. Both treatments are delivered through online sessions with a therapist. As an unphased trial, this study offers a unique opportunity to access innovative therapies tailored for pregnant women.

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's best to discuss this with the trial coordinators or your healthcare provider.

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

Studies have shown that Cognitive Behavioral Therapy for Insomnia (CBTI) is a safe option during pregnancy. This method avoids medications, which benefits expectant mothers. Research indicates that CBTI effectively improves sleep without major safety concerns.

Early findings for Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) suggest it is also safe and well-received. Participants reported high satisfaction with the program, appreciating the online format and meditation app. This approach combines mindfulness, a type of meditation, with sleep strategies to manage insomnia. No significant negative effects have been reported, making it a promising option for pregnant women dealing with sleep issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for pregnancy-related insomnia because they are tailored specifically for the unique challenges of pregnant women. Unlike standard treatments like medication, which can have side effects, or general cognitive behavioral therapy, these approaches—CBTI and PUMAS—offer specialized techniques. CBTI combines sleep strategies like sleep restriction with cognitive therapy, and PUMAS adds mindfulness elements like guided meditations, all delivered via telemedicine. This personalized and holistic approach aims to improve sleep health without the need for medication, making it a safer option during pregnancy.

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

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBTI), one of the treatments in this trial, helps pregnant women overcome insomnia more quickly. In one study, women using CBTI improved their sleep in about 31 days, while those who didn't use it took about 48 days. CBTI combines sleep habits with mental strategies and is widely recognized as a top treatment for insomnia.

The Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) program, another treatment option in this trial, uses mindfulness and sleep techniques. Early studies suggest PUMAS can greatly reduce insomnia and depression symptoms in pregnant women. This therapy focuses on easing nighttime anxiety and promoting relaxation, which is important for better sleep. Both therapies show promise for treating pregnancy-related insomnia, but CBTI has more research backing its effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

The INSPIRE trial is for pregnant women between weeks 14-31 of a singleton pregnancy, who are struggling with insomnia and depression. Participants must be over 18, speak English, have internet access, and not work night shifts. It's not for those with high-risk pregnancies or conditions like epilepsy that make sleep restriction unsafe.

Inclusion Criteria

Adequate sleep opportunity

Reliable internet access for treatment and assessments

I am pregnant with one baby, between 14 to 31 weeks along.

Exclusion Criteria

Night or rotating shift work

Active suicidal intent (ideation is allowed)

Epworth Sleepiness Scale score > 15 (Excessive sleepiness)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PUMAS or CBTI therapy, consisting of 6 60-minute sessions delivered via telemedicine during pregnancy

6-9 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in insomnia and depression symptoms across the first postpartum year

12 months

Assessments at 3, 6, 9, and 12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia (CBTI)
• Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Trial Overview This study compares two therapies: Cognitive Behavioral Therapy for Insomnia (CBTI) and Perinatal Understanding of Mindful Awareness for Sleep (PUMAS). The goal is to see which therapy better reduces insomnia and depression symptoms in expecting mothers.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy for Insomnia (CBTI) Active Control 1 Intervention

CBTI combines behavioral sleep strategies with cognitive therapy. It is the first-line treatment for insomnia as recommended by the American College of Physicians and the American Academy of Sleep Medicine. Behavioral sleep strategies include sleep restriction and stimulus control. Cognitive therapy includes scheduled worry time and challenging dysfunctional beliefs about sleep. CBTI consists of 6 60-minute sessions with a therapist along with self-monitoring with sleep diaries. All sessions are delivered via telemedicine during pregnancy.

Group II: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) Active Control 1 Intervention

PUMAS combines behavioral sleep strategies with elements from mindfulness-based interventions, and is tailored specifically to meet the unique needs of pregnant women. Behavioral sleep strategies include sleep restriction and stimulus control. Mindfulness elements include guided meditations and engaging in mindful activities. PUMAS consists of 6 60-minute sessions with a therapist along with self-monitoring with sleep diaries. All sessions are delivered via telemedicine during pregnancy.

Cognitive Behavioral Therapy for Insomnia (CBTI) is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Sleep disturbances during pregnancy

Approved in European Union as Cognitive Behavioural Therapy for Insomnia for:

• Insomnia
• Sleep disturbances during pregnancy

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

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]

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]

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]

Cognitive Behavioral Therapy for Insomnia (CBTI) is recognized as the first-line treatment for chronic insomnia, supported by strong empirical evidence of its effectiveness, particularly in cases of primary insomnia.

Recent developments in CBTI show promising results for treating insomnia alongside other health conditions, its use as a maintenance therapy, and the potential for delivering CBTI through technology and in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. Siebern, AT., Manber, R.[2022]

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 mindfulness sleep program (PUMAS) significantly reduced cognitive arousal in pregnant women with insomnia, with 75% reporting high cognitive arousal before treatment, dropping to only 8.3% after treatment, indicating a potential mechanism for alleviating insomnia.

Lower levels of cognitive arousal and sleep effort were linked to improvements in both insomnia and depression, suggesting that addressing these factors could enhance the effectiveness of mindfulness-based therapies for pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing cognitive arousal and sleep effort alleviates insomnia and depression in pregnant women with DSM-5 insomnia disorder treated with a mindfulness sleep program. Kalmbach, DA., Cheng, P., Reffi, AN., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6485299/

Cognitive Behavioral Therapy for Prenatal Insomnia Women receiving cognitive behavioral therapy for insomnia experienced faster remission of insomnia disorder, with a median of 31 days vs 48 days in the control ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30969203/

Cognitive Behavioral Therapy for Prenatal Insomnia - PubMed Women receiving cognitive behavioral therapy for insomnia experienced faster remission of insomnia disorder, with a median of 31 days vs 48 days in the control ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945723004203

A comprehensive insight on cognitive behavioral therapy ... Highlights · CBT-I demonstrated short-term improvement in insomnia among pregnant women. · The longer-term effectiveness of CBT-I in insomnia remains uncertain.

4. tandfonline.com tandfonline.com/doi/full/10.1080/15402002.2025.2501704

Cognitive Behavioral Therapy for Perinatal Insomnia This study explored the perceived usefulness and adherence of CBT-I components during the perinatal period, and examined their associations with ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37343335/

A single-arm proof-of-concept clinical trial of a mindfulness ... This proof-of-concept trial evaluated Perinatal Understanding of Mindful Awareness for Sleep (PUMAS, which combines mindfulness with behavioral sleep ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05710991

Brief Cognitive Behavioural Therapy for Insomnia Versus ... CBT is the first-line treatment for insomnia and promising research on CBT for insomnia specifically during pregnancy and postpartum is emerging. Intervention/ ...

7. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10572

Randomized controlled trial of cognitive behavioral therapy for ... Cognitive behavioral therapy for insomnia (CBTI) is well-suited during pregnancy and the postpartum period because it does not require taking sleep medications.

8. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2758827

Efficacy of Digital Cognitive Behavioral Therapy for the ... In this trial, digital CBT was an effective, scalable, safe, and acceptable intervention for improving insomnia symptoms during pregnancy.