Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement for Sleep

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Sleep+1 More
Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement - Behavioral
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a mindfulness-based stress reduction program plus a prenatal sleep supplement is more effective than treatment as usual for pregnant people with poor sleep quality.

See full description

Eligible Conditions

  • Sleep
  • Pregnancy Related

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement will improve 1 primary outcome and 18 secondary outcomes in patients with Sleep. Measurement will happen over the course of Baseline and post-intervention, an average of 12 weeks.

Week 12
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) from baseline to 12 weeks
Change in Insomnia Severity Index score (ISI) from baseline to 12 weeks
Change in Measures for coping with sleep disturbances score from baseline to 12 weeks
Change in PROMIS 6-item anxiety score from baseline to 12 weeks
Change in Perceived Stress Scale score (PSS) from baseline to 12 weeks
Change in Pittsburgh Sleep Quality Index score (PSQI) from baseline to 12 weeks
Change in Rumination-Reflection Questionnaire (RRQ) from baseline to 12 weeks
Change in Self Compassion Scale - Short Form (SCS-SF) from baseline to 12 weeks
Change in Worry about sleep score from baseline to 12 weeks
Completeness of study measures at baseline and at 12 weeks
Week 12
Among participants randomized to MBSR+PS, attendance of MBSR and PS supplement sessions from baseline to 12 weeks
Among participants randomized to MBSR+PS, duration of home practices from baseline to 12 weeks
Among participants randomized to MBSR+PS, frequency of home practices from baseline to 12 weeks
Among those randomized to MBSR+PS, number of participants who attend at least one session of MBSR and the PS supplement from baseline to 12 weeks
Change in Patient Health Questionnaire-9 score (PHQ-9) from baseline to 12 weeks
Week 12
Among those randomized to MBSR+PS, 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
Number of participants completing endpoint measures at 12 weeks

Trial Safety

Trial Design

1 Treatment Group

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS)
1 of 1
Experimental Treatment

This trial requires 52 total participants across 1 different treatment group

This trial involves a single treatment. Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS)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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-intervention, an average of 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly post-intervention, an average of 12 weeks for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pregnancy 12-28 weeks gestation at time of intervention start
18 years of age or older
Regular access to a web-enabled computer, phone or tablet
Ability to read and speak English, and to provide informed consent
Poor sleep quality (PSQI > 5)

Patient Q&A Section

What are the signs of sleep?

"Sleep disordered breathing is observed as snoring, restless sleep and daytime sleepiness. Sleep apnea syndrome may also show abnormal pulse oxymetry, nasal air flow, high altitude, low oxygen saturation and" - Anonymous Online Contributor

Unverified Answer

Can sleep be cured?

"Insomnia can be alleviated, as can excessive daytime sleepiness, through the management of pain and sleep-onset and sleep-phase disorders including circadian sleep-wake rhythms. In addition to managing sleep and sleep-onset disorders, good sleep hygiene can be practiced to improve the quality of sleep." - Anonymous Online Contributor

Unverified Answer

How many people get sleep a year in the United States?

"Approximately 7 million Americans get less than the recommended 6 consecutive hours of sleep a day. sleep a year. Among men, poor sleep may be associated with increased adiposity, poorer weight control and weight gain after cancer treatment, poorer physical fitness, and reduced sexual function." - Anonymous Online Contributor

Unverified Answer

What causes sleep?

"Sleep is a continuum of different stages of drowsiness that is influenced by both internal and external biological and psychological factors. Different forms of sleep-wake disorders can arise because of disturbances in these systems and may be resolved by treatment aimed at correcting for the disturbed sleep." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleep?

"Sleep is an important component of treatment for all stages of disease, and treatment is tailored to the stage of the disease and the individual patient.\n" - Anonymous Online Contributor

Unverified Answer

What is sleep?

"Sleep is an important concept that affects everyday life and needs to be properly understood and regulated. Sleep deprivation is associated with cognitive deficits, attention, mood and cognitive impairments. In addition to sleep quality, circadian rhythm sleep-wake disturbances like jet lag are frequent and common complaints among the working world. Sleep may be affected by both objective and subjective factors. Objective factors can be measured with polysomnography, which allows quantification of sleep duration, sleep architecture, sleepiness as well as sleep spindles and spindles per hour. Subjective factors can be measured e.g. with questionnaires like the Multiple Sleep Latency Test." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of sleep?

"Results from a recent clinical trial, the primary cause of sleep was found to be tired. As many as 30% of the adults in a general survey of the USA said that they feel "too tired" to fall asleep, but the actual frequency of falls during the day is not significantly and probably not importantly different from that of adults of the same age who cannot sleep at all, or at least rarely. Results from a recent clinical trial are consistent with those found in a number of previous studies that have shown that people who are tired are more likely to sleep in less naturalistic settings such as hotels." - Anonymous Online Contributor

Unverified Answer

What does mindfulness-based stress reduction plus prenatal sleep supplement usually treat?

"We have found preliminary evidence that prenatal mindfulness may be an effective adjunct therapy for anxiety during pregnancy, both to treat and to improve. The findings show a strong effect that is not affected by an accompanying post-treatment intervention." - Anonymous Online Contributor

Unverified Answer

Does mindfulness-based stress reduction plus prenatal sleep supplement improve quality of life for those with sleep?

"MBSR plus prenatal sleep supplement is associated with increased time spent in sleep, improved sleep hygiene, and improved quality of life for women with sleep problems. MBSR plus prenatal sleep is an effective complement to conventional care for women with sleep-related problems. Future trials should validate the effect of MBSR and prenatal sleep on menopausal or postpartum sleep and quality of life." - Anonymous Online Contributor

Unverified Answer

What is the latest research for sleep?

"There may be a circadian delay at certain times of the day. If there is, the average time it takes for this to happen is approximately 8 hours. It also might be the case that this delay varies drastically. There might also be a very slight difference in individuals. It may also be the case that the circadian phase is reset on an annual cycle, for example, every other year. This is one way to see if some changes in timing exist." - Anonymous Online Contributor

Unverified Answer

How serious can sleep be?

"Sleep complaints are common, but serious ones remain undiagnosed and untreated by healthcare professionals. Sleep complaints are often an indicator of medical conditions that require medical and psychological treatment, especially if they are recurrent in nature and cause significant psychological distress. Even moderate sleep complaints often lead to a thorough medical work-up, which can help rule out some (usually mild) medical conditions that lead to sleep disturbances. Although sleep complaints may indicate a lack of sleep, the severity of the complaints will also be relevant and should alert the physician to potential underlying, serious illnesses and medical conditions. Sleep complaints have been suggested by some researchers to be an important factor in the genesis of insomnia." - Anonymous Online Contributor

Unverified Answer

Does sleep run in families?

"Data from a recent study provides evidence for an interaction, but not for a genetic dimension, between the family pattern of sleep and the sleep duration of the family members. This might be due to the role played by age on sleep duration and its familial nature. The role of the familial dimension of sleep on a given individual's sleep duration requires further investigation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Sleep by sharing your contact details with the study coordinator.