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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.

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.

What data supports the effectiveness of the treatment Mindfulness-Based Therapy for Pregnancy-Related Insomnia?

Research suggests that combining mindfulness with behavioral sleep strategies, like in the PUMAS program, can improve sleep, reduce anxiety, and enhance maternal-fetal attachment in pregnant women with insomnia. Cognitive-behavioral therapy for insomnia (CBTI) has shown early evidence of improving sleep and mood in pregnant women, although it may need tailoring for better effectiveness in this group. ^{1 2 3 4 5}

Is mindfulness-based therapy for pregnancy-related insomnia safe?

Mindfulness-based therapy for insomnia, including Cognitive Behavioral Therapy for Insomnia (CBTI) and Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), is generally considered safe for treating insomnia. It is a non-drug approach that has been recommended as a standard treatment for insomnia by health authorities due to its effectiveness and safety profile. ^{3 4 6 7 8}

How is the treatment for pregnancy-related insomnia different from other treatments?

The PUMAS treatment is unique because it combines mindfulness techniques with behavioral sleep strategies, specifically tailored for pregnant women, to reduce cognitive arousal and improve sleep, mood, and maternal-fetal attachment, unlike standard cognitive-behavioral therapy for insomnia which may not fully address these specific needs. ^{1 2 3 4 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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 '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]

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]

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]

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 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]

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

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]

3. 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]

4. 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]

5. 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]

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. New Zealand pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]

9. United States 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. [2023]