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Mindfulness-Based Therapy for Pregnancy-Related Insomnia (INSPIRE Trial)

N/A
Recruiting
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
Singleton pregnancy between gestational week 14-31
Age ≥ 18 and English-speaking
Must not have
Health condition unsafe for sleep restriction (e.g., bipolar disorder, epilepsy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the investigators will examine changes in epds scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum.
Awards & highlights

Summary

This trial will test whether mindfulness-based therapy can help reduce symptoms of insomnia and comorbid depression in pregnant women.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As the interventions involve behavioral therapies rather than medications, side effects may include discomfort from discussing personal issues or temporary increases in stress due to changes in thinking patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am pregnant with one baby, between 14 to 31 weeks along.
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I am 18 years or older and speak English.
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I have been diagnosed with insomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a health condition like bipolar disorder or epilepsy that makes sleep restriction unsafe for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the investigators will examine changes in psasc scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the investigators will examine changes in psasc scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparative effectiveness between PUMAS and CBTI on acute insomnia effects.
Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects.
Secondary outcome measures
Comparative effectiveness between PUMAS and CBTI on acute cognitive arousal effects.
Comparative effectiveness between PUMAS and CBTI on acute depression effects.
Comparative effectiveness between PUMAS and CBTI on postpartum cognitive arousal effects.
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Cognitive Behavioral Therapy for Insomnia (CBTI)Active Control1 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 Control1 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.

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Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
305 Previous Clinical Trials
2,107,880 Total Patients Enrolled
10 Trials studying Insomnia
1,623 Patients Enrolled for Insomnia

Media Library

Cognitive Behavioral Therapy for Insomnia (CBTI) Clinical Trial Eligibility Overview. Trial Name: NCT05356364 — N/A
Insomnia Research Study Groups: Cognitive Behavioral Therapy for Insomnia (CBTI), Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
Insomnia Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia (CBTI) Highlights & Side Effects. Trial Name: NCT05356364 — N/A
Cognitive Behavioral Therapy for Insomnia (CBTI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05356364 — N/A
~43 spots leftby Aug 2025
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