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Behavioral Intervention

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

N/A
Waitlist Available
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 we will examine change in psasc from pretreatment to posttreatment (8 weeks later).
Awards & highlights

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

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.
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.
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.

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~we will examine onset of major depression (epds scores 13 or higher) at posttreatment (8 weeks after baseline) and assessed monthly across the first postpartum year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and we will examine onset of major depression (epds scores 13 or higher) at posttreatment (8 weeks after baseline) and assessed monthly across the first postpartum year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depression prevention
Insomnia effectiveness
Secondary outcome measures
Pre-sleep cognitive arousal

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., we 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.

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Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
305 Previous Clinical Trials
2,107,480 Total Patients Enrolled
10 Trials studying Insomnia
1,223 Patients Enrolled for Insomnia
David A Kalmbach, PhDPrincipal InvestigatorHenry Ford Health
~333 spots leftby Sep 2028
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