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Mindfulness-Based Therapy for Pregnancy-Related Insomnia (INSPIRE Trial)
INSPIRE Trial Summary
This trial will test whether mindfulness-based therapy can help reduce symptoms of insomnia and comorbid depression in pregnant women.
INSPIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowINSPIRE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.INSPIRE Trial Design
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Who is running the clinical trial?
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- I am pregnant with one baby, between 14 to 31 weeks along.I am 18 years or older and speak English.I have been diagnosed with insomnia.I do not have a health condition like bipolar disorder or epilepsy that makes sleep restriction unsafe for me.I am over 40 or have a high-risk pregnancy due to conditions like pre-eclampsia.
- Group 1: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
- Group 2: Cognitive Behavioral Therapy for Insomnia (CBTI)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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)."
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."
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