Behavioral Intervention

Mindfulness-Based Sleep Program for Depression During Pregnancy (STRIDE P Trial)

Novi, MI

Phase 2

Recruiting

Led By David A Kalmbach, PhD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DSM-5 Insomnia Disorder (≥1 month duration)

Not currently engaged in therapy for major depression or insomnia disorder

Must not have

Untreated RLS (treated RLS is OK)

Uncontrolled sleep or mental disorder inappropriate or unsafe for sleep restriction (narcolepsy, bipolar, epilepsy, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the investigators will examine onset of perinatal depression (epds scores 13 or higher) at posttreatment (8 weeks after baseline) and assessed monthly for 1 year after childbirth.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a mindfulness-based sleep program for pregnant women to improve their sleep quality and reduce the risk of perinatal depression. Perinatal depression is a common issue during pregnancy and after

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves a non-medical intervention focusing on mindfulness and sleep improvement techniques, significant side effects are not anticipated. However, participants may experience varying levels of comfort with the practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I do not have a current diagnosis of major depression.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I often feel very sleepy during the day.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the investigators will examine change in isi from pretreatment baseline to posttreatment (8 weeks after baseline), and monthly for 1 year after childbirth..

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the investigators will examine change in isi from pretreatment baseline to posttreatment (8 weeks after baseline), and monthly for 1 year after childbirth..

This trial's timeline: 3 weeks for screening, Varies for treatment, and the investigators will examine change in isi from pretreatment baseline to posttreatment (8 weeks after baseline), and monthly for 1 year after childbirth.. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparative effectiveness between PUMAS and standard care on changes in insomnia symptoms.

Comparative effectiveness of PUMAS and standard care on prevention of perinatal depression.

Secondary study objectives

Comparative effectiveness between PUMAS and standard care on nocturnal cognitive arousal symptoms.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)Experimental Treatment1 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 Control1 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.

0 / 6Eligibility criteria met