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Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement for Sleep (RISE Trial)

N/A
Waitlist Available
Led By Jennifer N Felder, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention, an average of 12 weeks
Awards & highlights

RISE Trial Summary

This trial is looking at whether a mindfulness-based stress reduction plus prenatal sleep supplement is more effective than usual treatment at improving sleep quality for pregnant people.

Eligible Conditions
  • Sleep
  • Pregnancy

RISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention, an average of 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention, an average of 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With a Total Score Greater Than or Equal to 24 on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 12 Weeks
Secondary outcome measures
Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks
Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks
+15 more

RISE Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment as UsualExperimental Treatment1 Intervention
The control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy, with the exception of asking participants to refrain from participating in non-study mindfulness practice. Use of non-study treatment will be tracked.
Group II: Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS)Experimental Treatment2 Interventions
The study intervention is standard mindfulness-based stress reduction (MBSR), which will be delivered through 8 weekly 2.5-hour sessions via video conferencing to groups of 20-30 pregnant and non-pregnant people. MBSR also consists of a 2.5-hour orientation session, a 30-minute private interview with the instructor, and an all-day retreat, all conducted via video conferencing. The supplemental prenatal sleep content will be delivered through 6-8 30-minute sessions via video conferencing either individually or to small groups, and draws material from mindfulness-based therapy for insomnia, mindfulness-based childbirth and parenting program, and cognitive behavior therapy for prenatal insomnia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement
2021
N/A
~60

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,419 Total Patients Enrolled
6 Trials studying Sleep
465 Patients Enrolled for Sleep
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,881 Total Patients Enrolled
6 Trials studying Sleep
916 Patients Enrolled for Sleep
Jennifer N Felder, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
706 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants still being signed up for this clinical trial?

"No, this study is not currently looking for participants. According to the information available on clinicaltrials.gov, the trial was posted on September 8th 2021 and last updated on October 5th 2022. Although this study isn't open for enrollment, there are 287 other trials that are still recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
California
Arizona
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Research on Improving Sleep During Pregnancy
2021. "Research on Improving Sleep During Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05017974.
~15 spots leftby Apr 2025
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