N/A
Completed N=52
Research on Improving Sleep During Pregnancy
Sleep · Pregnancy Related
Source: ClinicalTrials.gov NCT05017974 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: 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
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).
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 | — |
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)
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. Informational only — not medical advice.