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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 isi scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum..

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

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.

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

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

Primary study objectives

Comparative effectiveness between PUMAS and CBTI on acute insomnia effects.

Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects.

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 4Eligibility criteria met