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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
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
No Placebo-Only Group

INSPIRE Trial 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.

INSPIRE Trial 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.

INSPIRE Trial 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..
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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.. 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

INSPIRE Trial Design

2Treatment groups
Active Control
Group I: 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.
Group II: 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.

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
298 Previous Clinical Trials
2,434,853 Total Patients Enrolled
9 Trials studying Insomnia
1,123 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: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), Cognitive Behavioral Therapy for Insomnia (CBTI)
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for participants in this research study?

"According to information found on clinicaltrials.gov, this particular medical trial is not currently open for recruitment. Having been first posted in September 1st 2022 and last updated August 4th 2022; however, there are presently 1347 other studies actively soliciting participants."

Answered by AI

What are the criteria for being eligible to join this research project?

"100 adult participants (ages 18-40) with depression, as measured by an EPDS score of 10 or higher, are needed for this study. Additionally, they must have had a singleton pregnancy between gestational weeks 14 and 31; have been diagnosed with DSM-5 Insomnia Disorder (acute or chronic), evidenced by an ISI score of 11+; be able to ensure adequate sleep opportunity; speak English fluently and possess reliable internet access for treatment and assessments."

Answered by AI

To what goals is this experiment hoping to contribute?

"This research will be tracked for a duration of 12 months postpartum, with assessments made at 3, 6, 9 and 12 month intervals. The primary objective is to compare the effectiveness of PUMAS and CBTI in alleviating acute insomnia symptoms. Secondary objectives include determining comparative efficacy between the two treatments in abating cognitive arousal associated with sleep disturbances as measured on the PSASC scale (scores ranging from 8-40), attenuating depressive symptoms according to EPDS scores (range 0-30) and reducing nocturnal cognitive arousal intensity assessed by means of PSASC scores (8-40)."

Answered by AI

Are those aged 85 and above able to participate in this clinical investigation?

"The age parameters for enrolment into this study are those that are above the legal adulting and below four decades old."

Answered by AI
~60 spots leftby Aug 2025