Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Henry Ford Medical Center, Novi, MI
Depression+2 More
Cognitive Behavioral Therapy for Insomnia (CBTI) - Behavioral
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.

Eligible Conditions

  • Depression
  • Insomnia

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 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..

Week 9
Comparative effectiveness between PUMAS and CBTI on acute depression effects.
Week 9
Comparative effectiveness between PUMAS and CBTI on acute insomnia effects.
Week 9
Comparative effectiveness between PUMAS and CBTI on acute cognitive arousal effects.
Month 12
Comparative effectiveness between PUMAS and CBTI on postpartum depression effects.
Month 12
Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects.
Month 12
Comparative effectiveness between PUMAS and CBTI on postpartum cognitive arousal effects.

Trial Safety

Trial Design

2 Treatment Groups

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
1 of 2
Cognitive Behavioral Therapy for Insomnia (CBTI)
1 of 2
Active Control

100 Total Participants · 2 Treatment Groups

Primary Treatment: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) · No Placebo Group · N/A

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
Behavioral
ActiveComparator Group · 1 Intervention: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) · Intervention Types: Behavioral
Cognitive Behavioral Therapy for Insomnia (CBTI)
Behavioral
ActiveComparator Group · 1 Intervention: Cognitive Behavioral Therapy for Insomnia (CBTI) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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..
Closest Location: Henry Ford Medical Center · Novi, MI
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2009First Recorded Clinical Trial
2 TrialsResearching Depression
37 CompletedClinical Trials

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
257 Previous Clinical Trials
2,011,075 Total Patients Enrolled
3 Trials studying Depression
1,498 Patients Enrolled for Depression

Eligibility Criteria

Age 18 - 65 · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a score of 10 or more on the Edinburgh Postnatal Depression Scale.
You are aged 18 or older, and you are a native English speaker.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.