Research on Improving Sleep During Pregnancy

Sleep Clinical Trial

— RISE  

Official title:

Randomized Controlled Trial of Mindfulness-based Stress Reduction Plus Prenatal Sleep Supplement Versus Usual Care: Acceptability, Feasibility, and Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05017974
• Other study ID #: 20-32853
• Secondary ID: K23AT009896
• Status: Completed
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: July 14, 2022

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Poor sleep quality is highly prevalent during pregnancy, with important implications for maternal and infant health and well-being. Despite this, there is limited research on interventions to improve prenatal sleep, and prior research did not target the specific factors contributing to poor sleep quality in this population. Specifically, pregnant people report that physical symptoms, including discomfort and pain, disturb their sleep. In non-pregnant populations, this pain-sleep relationship is bidirectional, and maladaptive psychological responses to pain further exacerbate poor sleep. Theory and empirical evidence indicate that mindfulness-based interventions may be effective for targeting these psychological responses. 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). Participants will be recruited to complete study questionnaires at two timepoints during pregnancy. Participants randomized to MBSR+PS will receive usual care, will be asked to attend 8 weekly group MBSR sessions (in addition to the MBSR orientation session, 1:1 interview with the instructor, and daylong retreat) and 6-8 PS sessions individually or in small groups, and will complete daily sleep and home practice diaries. Participants randomized to treatment as usual will receive usual care. The specific aims are: 1. To determine acceptability of MBSR+PS. 2. To determine feasibility of MBSR+PS. 3. To determine adherence to MBSR+PS. 4. To explore evidence of change in psychological mediators. 5. To explore between-group differences in sleep. 6. To explore group differences in other critical clinical outcomes (e.g. depressive symptoms, anxiety symptoms, stress). There is strong conceptual basis to predict the potential benefit of this approach for pregnant people. Targeting psychological responses to poor sleep during pregnancy may have significant public health benefits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 14, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy Related
• Sleep

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement
MBSR+PS

Other:
• Treatment as Usual
TAU

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	Post-intervention, an average of 12 weeks
Secondary	Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks	Participants can attend 0-8 sessions of MBSR and of PS.	Baseline to post-intervention, an average of 12 weeks
Secondary	Number of Participants Completing Endpoint Measures at 12 Weeks	For a measure to be considered complete, at least 95% of items must be completed.	Post-intervention, an average of 12 weeks
Secondary	Completeness of Study Measures at Baseline and at 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.	Baseline and post-intervention, an average of 12 weeks
Secondary	Percentage of MBSR and PS Sessions Attended	This measure will not be collected for participants randomized to TAU.	Baseline to post-intervention, an average of 12 weeks
Secondary	Frequency of Home Practices From Baseline to 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.	Baseline to post-intervention, an average of 12 weeks
Secondary	Duration of Home Practices From Baseline to 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.	Baseline to post-intervention, an average of 12 weeks
Secondary	Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 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.	Baseline and post-intervention, an average of 12 weeks
Secondary	Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 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.	Baseline and post-intervention, an average of 12 weeks
Secondary	Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 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.	Baseline and post-intervention, an average of 12 weeks
Secondary	Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 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.	Baseline and post-intervention, an average of 12 weeks
Secondary	Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 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.	Baseline and post-intervention, an average of 12 weeks
Secondary	Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks	The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity. The change in ISI score from baseline to post-intervention (at 12 weeks) will be reported.	Baseline and post-intervention, an average of 12 weeks
Secondary	Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks	The Dysfunctional Beliefs About Sleep (DBAS) score ranges from 0 to 10, with a score of 4 or greater indicating unrealistic expectations for sleep, and greater scores indicating more dysfunctional beliefs about sleep. The change in DBAS score from baseline to post-intervention (at 12 weeks) will be reported.	Baseline and post-intervention, an average of 12 weeks
Secondary	Change in Measures for Coping With Sleep Disturbances Score From Baseline to 12 Weeks	The Measures for coping with sleep disturbances score ranges from 0 to 11, with greater scores indicating greater use of active coping measures for sleep disturbance. The change in Measures for coping with sleep disturbances score from baseline to post-intervention (at 12 weeks) will be reported.	Baseline and post-intervention, an average of 12 weeks
Secondary	Worry About Sleep Duration	Single item measure that assesses whether participants worried about not getting enough sleep in the past 2 weeks.	Post-intervention, an average of 12 weeks
Secondary	Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks	The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with a score greater than or equal to 10 indicating moderate to severe depression, and the higher the score, the greater the depressive symptom severity. The change in PHQ-9 score from baseline to post-intervention (at 12 weeks) will be reported.	Baseline to post-intervention, an average of 12 weeks
Secondary	Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks	The PROMIS 6-item anxiety score ranges from 6 to 30, with higher scores indicating more severe anxiety; from raw scores, standardized T-scores can be determined. The change in PROMIS 6-item anxiety T-score from baseline to post-intervention (at 12 weeks) will be reported. The T-score values have a mean = 50 and SD = 10, with higher scores indicating greater anxiety.; The T-scores are interpreted as follows: Less than 55 = None to slight anxiety 55.0-59.9 = Mild anxiety 60.0-69.9 = Moderate anxiety 70 and over = Severe anxiety	Baseline and post-intervention, an average of 12 weeks
Secondary	Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks	The Perceived Stress Scale score ranges from 0 to 40, with higher scores indicating greater appraisal of stress. The change in PSS score from baseline to post-intervention (at 12 weeks) will be reported.	Baseline and post-intervention, an average of 12 weeks