NCT05017974: RISE

Research on Improving Sleep During Pregnancy

Completed NA Results posted Last updated 18 November 2023

What this trial tests

NA trial testing Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement in Sleep in 52 participants. Completed in 14 July 2022.

Timeline

8 September 2021

Primary endpoint
29 June 2022

14 July 2022

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	52
Start date	8 September 2021
Primary completion	29 June 2022
Estimated completion	14 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement
• Treatment as Usual

Conditions studied

• Sleep — all drugs for Sleep →
• Pregnancy Related — all drugs for Pregnancy Related →

Sponsor

University of California, San Francisco

Who can join

18 and older, female only, with Sleep or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · Post-intervention, an average of 12 weeks

The Client Satisfaction Questionnaire (CSQ-8) score ranges from 8 to 32, with high scores indicating greater satisfaction. The CSQ-8 score of participants randomized to MBSR+PS will be reported; participants randomized to TAU will not complete the CSQ-8 as the questions pertain to the MBSR+PS program.

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	20

Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks Secondary · Baseline to post-intervention, an average of 12 weeks

Participants can attend 0-8 sessions of MBSR and of PS.

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	23

Number of Participants Completing Endpoint Measures at 12 Weeks Secondary · Post-intervention, an average of 12 weeks

For a measure to be considered complete, at least 95% of items must be completed.

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	24
Treatment as Usual	24

Completeness of Study Measures at Baseline and at 12 Weeks Secondary · Baseline and post-intervention, an average of 12 weeks

For a measure to be considered complete, at least 95% of items must be completed. Completeness of study measures at baseline and 12 weeks are combined (averaged); the percentage of measures completed across timepoints is reported.

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	95.2
Treatment as Usual	96.1

Percentage of MBSR and PS Sessions Attended Secondary · Baseline to post-intervention, an average of 12 weeks

This measure will not be collected for participants randomized to TAU.

MBSR attendance

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	80.00	± 8.08

PS attendance

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	82.00	± 7.10

Frequency of Home Practices From Baseline to 12 Weeks Secondary · Baseline to post-intervention, an average of 12 weeks

Participants randomized to MBSR+PS will complete daily diaries reporting their formal and informal practices. Participants randomized to TAU will not complete this measure.

MBSR Home Practice

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	85.84	± 17.99

PS Home Practice

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	96.66	± 4.19

Duration of Home Practices From Baseline to 12 Weeks Secondary · Baseline to post-intervention, an average of 12 weeks

Participants randomized to MBSR+PS will complete daily diaries reporting their formal and informal practices. Participants assigned to TAU will not complete this measure.

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	36.21	± 35.00

Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks Secondary · Baseline and post-intervention, an average of 12 weeks

The Self Compassion Scale - Short Form (SCS-SF) score ranges from 1 to 5, with higher scores indicating greater self-compassion. The change in SCS-SF score from baseline to post-intervention (at 12 weeks) will be reported.

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	1.12	± 5.64
Treatment as Usual	2.71	± 7.57

Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks Secondary · Baseline and post-intervention, an average of 12 weeks

We included two factors of the Five-Facet Mindfulness Questionnaire (FFMQ): the nonjudging factor (score ranges from 8 to 40) and the non-reactivity factors (score ranges from 7 to 35). Higher scores indicate greater mindfulness. The change in factor scores from baseline to post-intervention (at 12 weeks) will be reported.

Nonjudging score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	2.00	± 4.17
Treatment as Usual	1.58	± 5.72

Nonreacting score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	2.04	± 5.15
Treatment as Usual	1.46	± 4.20

Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks Secondary · Baseline and post-intervention, an average of 12 weeks

The Coping Strategies Questionnaire - Revised (CSQ-R) score ranges from 0 to 36 on each of the 7 subscales, with higher scores indicating greater use of a coping strategy. The change in CSQ score from baseline to post-intervention (at 12 weeks) will be reported.

Distracting score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	.38	± .73
Treatment as Usual	-.09	± .98

Catastrophizing score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	-.36	± .58
Treatment as Usual	-.14	± 1.04

Ignoring score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	-.25	± 1.03
Treatment as Usual	.03	± 1.21

Distancing score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	.54	± 1.34
Treatment as Usual	.41	± .98

Coping score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	-.08	± .93
Treatment as Usual	-.05	± .97

Praying score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	.04	± .95
Treatment as Usual	.33	± 1.09

Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks Secondary · Baseline and post-intervention, an average of 12 weeks

The Rumination-Reflection Questionnaire (RRQ) score ranges from 12 to 60 for each of the two factors. Greater scores indicate greater tendency to ruminate and reflect. The change in RRQ score from baseline to post-intervention (at 12 weeks) will be reported.

Rumination score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	-1.46	± 6.85
Treatment as Usual	-2.75	± 5.84

Reflection score

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	.96	± 3.85
Treatment as Usual	-.13	± 5.04

Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks Secondary · Baseline and post-intervention, an average of 12 weeks

The Pittsburgh Sleep Quality Index (PSQI) score ranges from 0 to 21. A total score of 5 or more indicates poor sleep quality; the higher the score, the worse the sleep quality. The change in PSQI score from baseline to post-intervention (at 12 weeks) will be reported.

Group	Value	95% CI
Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)	-2.58	± 2.21
Treatment as Usual	-1.79	± 2.06

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness-Based Stress Reduction Plus Prenatal Sleep Supplement (MBSR+PS)

Serious: 0/26 (0%)

Deaths: 0/26

Treatment as Usual

Serious: 0/26 (0%)

Deaths: 0/26

Other adverse events (8 terms — click to expand)

Reaction	System	Mindfulness-Based Stress R…	Treatment as Usual
COVID diagnosis	Infections and infestations	—	—
gestational diabetes dx	Pregnancy, puerperium and perinatal conditions	—	—
Elevated anxiety symptoms	Psychiatric disorders	—	—
Elevated depressive symptoms	Psychiatric disorders	—	—
Hidradenitis	Skin and subcutaneous tissue disorders	—	—
High blood pressure	Cardiac disorders	—	—
Passive suicidal ideation	Psychiatric disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—

Data from ClinicalTrials.gov NCT05017974 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.