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Behavioural Intervention

PUMAS Treatment for Insomnia

N/A
Waitlist Available
Led By David Kalmbach, PhD
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
Awards & highlights

Study Summary

This trial is examining whether a mindfulness-based intervention can help improve sleep and mood for pregnant women who are struggling with insomnia. The intervention will be delivered via telemedicine, so it can be done from the comfort of the participant's home.

Eligible Conditions
  • Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
This trial's timeline: 3 weeks for screening, Varies for treatment, and pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of PUMAS for changes in insomnia symptoms - Insomnia Severity Index (ISI)
Secondary outcome measures
Effectiveness of PUMAS for changes in depressive symptoms
Effectiveness of PUMAS for changes in of cognitive arousal- Presleep Arousal Scale- Cognitive Factor

Trial Design

1Treatment groups
Experimental Treatment
Group I: PUMAS TreatmentExperimental Treatment1 Intervention
Prenatal insomnia program that places behavioral sleep strategies within a mindfulness-based intervention framework that is geared toward pregnant women.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PUMAS
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,987 Total Patients Enrolled
9 Trials studying Insomnia
1,211 Patients Enrolled for Insomnia
David Kalmbach, PhDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
64 Total Patients Enrolled
1 Trials studying Insomnia
64 Patients Enrolled for Insomnia

Frequently Asked Questions

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

What criteria must be met for individuals to qualify as participants in this trial?

"This study is seeking 50 participants between 18 and 40 years of age who suffer from insomnia. The gestational age at the time of enrollment must be within 18-30 weeks, they must have an Insomnia Severity Index score over 11, and a reliable internet connection that can support online treatments and assessments."

Answered by AI

What aims does this medical experiment hope to accomplish?

"The goal of this clinical trial is to assess the effectiveness of PUMAS on insomnia symptoms using the Insomnia Severity Index (ISI). Secondary outcomes include assessing cognitive arousal through Presleep Arousal Scale- Cognitive Factor, which rates from 8 - 40 with higher scores indicating greater severity; evaluating how mindfulness based therapy impacts nocturnal cognitive arousal and depressive symptoms via Edinburgh Postnatal Depression (EPDS) scale ranging 0 - 30. The evaluation time frame spans pre-treatment, post treatment after 10 weeks or completing prenatal treatment, 1 month and 3 months following childbirth."

Answered by AI

Is eligibility for this trial contingent upon age, and if so, what is the cutoff?

"Adherence to the study's eligibility criteria necessitates that all participants must be at least 18 years old and can not exceed a maximum age of 40."

Answered by AI

Is the current trial open to enrollment?

"Affirmative. Clinicaltrials.gov records show that this clinical trial is actively searching for participants, having first being posted on August 15th 2022 and recently updated on September 16th 2022. The research team are looking to enlist 50 patients from a single medical centre."

Answered by AI

What is the cap on enrolment for this medical trial?

"Affirmative. Per the data posted on clinicaltrials.gov, this research is currently seeking participants and was first uploaded to the website in August 15th of 2022. This trial has been re-evaluated as recently as September 16th with a goal of including 50 patients at one location."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Henry Ford Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.
David Kalmbach 2022. "Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04443959.
~4 spots leftby Apr 2025
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