Mindfulness-Based Sleep Program for Depression During Pregnancy

(STRIDE P Trial)

Overseen By Christopher L Drake, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Henry Ford Health System

Disqualifiers: High risk pregnancy, Suicidal intent, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist pregnant women experiencing insomnia (trouble sleeping) in preventing depression before and after birth. It tests a mindfulness-based sleep program called PUMAS (Perinatal Understanding of Mindful Awareness for Sleep), which combines sleep strategies and mindfulness exercises through online sessions. Participants will either try PUMAS or receive usual treatment options like sleep aids and therapy. Pregnant women between weeks 14 and 31, who have experienced trouble sleeping for over a month and have no major depression, might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not be currently engaged in therapy for major depression or insomnia disorder.

What prior data suggests that the mindfulness-based sleep program is safe for pregnant women?

Research shows that the Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) is generally well-tolerated by pregnant women with insomnia. In earlier studies, participants experienced better sleep and less depression and mental stress. No serious side effects were reported from PUMAS. This therapy uses mindfulness techniques, combining sleep strategies with meditation exercises specifically designed for pregnancy. Although researchers continue to study this treatment, it seems safe and shows promise in improving sleep and mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) because it offers a new approach to managing prenatal insomnia, which is often treated with sleep aids, melatonin, or cognitive-behavioral therapy. PUMAS is unique because it combines behavioral sleep strategies with mindfulness exercises specifically tailored for pregnancy. Another exciting feature is its delivery method; PUMAS is conducted through telemedicine, making it accessible for expectant mothers who may have difficulty attending in-person sessions. This combination of tailored mindfulness and convenient access could significantly improve sleep quality for pregnant individuals experiencing depression.

What evidence suggests that the Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) program might be an effective treatment for perinatal depression?

Research has shown that the Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) program, which participants in this trial may receive, can significantly help pregnant women by reducing insomnia, depression, and mental restlessness. Women in studies who engaged with PUMAS experienced substantial improvements in sleep quality. The program combines simple sleep techniques with mindfulness exercises to reduce mental stress that can exacerbate sleep problems. Available through telemedicine, it offers expecting mothers easy and convenient access. Overall, PUMAS shows promise for improving sleep and may help lower the risk of depression during pregnancy. ^{1 2 3 5 6}

Who Is on the Research Team?

David A Kalmbach, PhD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

This trial is for pregnant women between weeks 14-31 who are not currently in therapy for major depression or insomnia, have no current severe depression or long-term insomnia disorder, and score moderately on the Insomnia Severity Index. They should not be at high risk of pregnancy complications nor work night shifts or plan extensive travel soon.

Inclusion Criteria

I am not currently receiving treatment for major depression or insomnia.

I do not have a current diagnosis of major depression.

I have been diagnosed with insomnia lasting more than a month.

Exclusion Criteria

I have Restless Leg Syndrome that hasn't been treated.

I do not have an uncontrolled sleep or mental disorder like narcolepsy or bipolar.

I often feel very sleepy during the day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PUMAS intervention or treatment-as-usual for prenatal insomnia, including six weekly 60-minute sessions delivered via telemedicine

8 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in insomnia symptoms, cognitive arousal, and perinatal depression monthly for 1 year after childbirth

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Trial Overview The study tests a mindfulness-based sleep program called PUMAS against usual treatment to see if it improves sleep and reduces cognitive arousal, potentially lowering the risk of perinatal depression during pregnancy and after birth.

How Is the Trial Designed?

Group I: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) Experimental Treatment 1 Intervention

PUMAS is a clinician-administered psychotherapy intervention for prenatal insomnia that includes six weekly 60-minute sessions in an individual format. PUMAS combines behavioral sleep strategies with mindfulness exercises and tailors all components to pregnancy to improve sleep quality. PUMAS will be delivered via telemedicine video.

Group II: Treatment-as-usual (TAU) Active Control 1 Intervention

TAU reflects real-world care where patients and their providers make their own treatment decisions for treating prenatal insomnia. Common TAU options include over-the-counter sleep aids, sleep hygiene education, melatonin, and cognitive-behavioral therapy for insomnia. The TAU group will be well-characterized (i.e., the investigators will monitor interventions administered by the usual care providers and collect information on dosage, frequency, duration, adherence) to best describe treatment options sought and completed in the real world.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

This study is testing a 6-week online mindfulness meditation program combined with cognitive-behavioral therapy for insomnia (CBT-I) to help pregnant women manage insomnia, with 50 participants recruited for a randomized controlled trial.

The primary goal is to assess the feasibility and efficacy of this intervention on sleep quality and mood, using various measures like the Pittsburgh Sleep Quality Index and daily sleep diaries, which could lead to a larger trial if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial. Kantrowitz-Gordon, I., McCurry, SM., Landis, CA., et al.[2022]

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]

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 65 pregnant women, over half reported clinical insomnia and a notable percentage experienced major depression, highlighting the prevalence of these issues during pregnancy.

Higher levels of everyday mindfulness were linked to significantly lower levels of nocturnal rumination, insomnia symptoms, and depressive symptoms, suggesting that mindfulness may serve as a protective factor against these perinatal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and nocturnal rumination are independently associated with symptoms of insomnia and depression during pregnancy. Kalmbach, DA., Roth, T., Cheng, P., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10402889/

Perinatal Understanding of Mindful Awareness for Sleep ... Prenatal insomnia patients were highly engaged in PUMAS, which produced large acute reductions in insomnia, depression, and cognitive arousal. These findings ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945723001958

A single-arm proof-of-concept clinical trial of a mindfulness ... Therapies aimed at reducing cognitive arousal may benefit pregnant women with insomnia. This proof-of-concept trial evaluated Perinatal Understanding of Mindful ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04443959

Telemedicine Mindfulness-based Therapy for Perinatal ... The purpose of this research study is to examine the effectiveness of a mindfulness-based intervention for prenatal insomnia via telemedicine format to improve ...

4. clinicalkey.com clinicalkey.com/#!/content/journal/1-s2.0-S1389945723001958?scrollTo=%23hl0000947

A single-arm proof-of-concept clinical trial of a mindfulness ... Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S138994572500245X

Reducing nocturnal cognitive arousal is a treatment ... CBTI and PUMAS are effective for prenatal insomnia, even in women with comorbid OSA. PUMAS may be especially beneficial for pregnant women presenting with PND.

6. 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 ...