N/A N=52 Randomized Single-blind Treatment

Research on Improving Sleep During Pregnancy

Sleep · Pregnancy Related

Bottom Line

View on ClinicalTrials.gov: NCT05017974 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: 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 — 20 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (Behavioral); Treatment as Usual (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Francisco
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	20	—
SECONDARY Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks	23	—
SECONDARY Number of Participants Completing Endpoint Measures at 12 Weeks	24; 24	—
SECONDARY Completeness of Study Measures at Baseline and at 12 Weeks	95.2; 96.1	—
SECONDARY Percentage of MBSR and PS Sessions Attended	80.00; 82.00	—
SECONDARY Frequency of Home Practices From Baseline to 12 Weeks	85.84; 96.66	—
SECONDARY Duration of Home Practices From Baseline to 12 Weeks	36.21	—
SECONDARY Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks	1.12; 2.71	—
SECONDARY Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks	2.00; 1.58; 2.04; 1.46	—
SECONDARY Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks	.38; -.09; -.36; -.14; -.25; .03	—
SECONDARY Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks	-1.46; -2.75; .96; -.13	—
SECONDARY Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks	-2.58; -1.79	—
SECONDARY Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks	-5.29; -4.17	—
SECONDARY Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks	-1.11; -.96	—
SECONDARY Change in Measures for Coping With Sleep Disturbances Score From Baseline to 12 Weeks	—	—
SECONDARY Worry About Sleep Duration	9; 8	—
SECONDARY Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks	-1.78; -1.38	—
SECONDARY Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks	-1.45; -2.32	—
SECONDARY Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks	-1.83; -2.46	—

Summary

The overarching goal is to utilize a randomized control design to examine acceptability, feasibility, and adherence of mindfulness-based stress reduction plus prenatal sleep supplement (MBSR+PS) compared to treatment as usual among pregnant people with poor sleep quality (n=50).

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

Self-reported sleep disorder (e.g. sleep apnea, narcolepsy, parasomnia, circadian rhythm disorder)
Shift-work or nighttime caregiving responsibilities
Psychological, medical, or other issues that necessitate priority treatment (e.g. active suicidality, probable depression (PHQ-9 ≥ 10), psychosis, on bed rest, multiple gestation)
Current regular mindfulness practice (>20 minutes/week)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05017974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.