RISE: Research on Improving Sleep During Pregnancy
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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:
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To determine acceptability of MBSR+PS.
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To determine feasibility of MBSR+PS.
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To determine adherence to MBSR+PS.
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To explore evidence of change in psychological mediators.
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To explore between-group differences in sleep.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement
MBSR+PS
Other: Treatment as Usual
TAU
|
| Other: Treatment as Usual The control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy, with the exception of asking participants to refrain from participating in non-study mindfulness practice. Use of non-study treatment will be tracked. |
Other: Treatment as Usual
TAU
|
Outcome Measures
Primary Outcome Measures
- 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 [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.
Secondary Outcome Measures
- 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 [Baseline to post-intervention, an average of 12 weeks]
This measure will only be collected for the MBSR+PS group; it is not applicable for participants randomized to TAU.
- Number of participants completing endpoint measures at 12 weeks [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 at 12 weeks [Baseline and post-intervention, an average of 12 weeks]
For a measure to be considered complete, at least 95% of items must be completed.
- Among participants randomized to MBSR+PS, attendance of MBSR and PS supplement sessions from baseline to 12 weeks [Baseline to post-intervention, an average of 12 weeks]
This measure will not be collected for participants randomized to TAU.
- Among participants randomized to MBSR+PS, frequency of home practices from baseline to 12 weeks [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.
- Among participants randomized to MBSR+PS, duration of home practices from baseline to 12 weeks [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.
- Change in Self Compassion Scale - Short Form (SCS-SF) from baseline to 12 weeks [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.
- Change in Five-Facet Mindfulness Questionnaire (FFMQ) from baseline to 12 weeks [Baseline and post-intervention, an average of 12 weeks]
The Five-Facet Mindfulness Questionnaire (FFMQ) score ranges from 8 to 40 for each of the five factors, except for the non-reactive factor which ranges from 7 to 35. Higher scores indicate greater mindfulness. The change in FFMQ score from baseline to post-intervention (at 12 weeks) will be reported.
- Change in Coping Strategies Questionnaire - Revised (CSQ-R) from baseline to 12 weeks [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.
- Change in Rumination-Reflection Questionnaire (RRQ) from baseline to 12 weeks [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.
- Change in Pittsburgh Sleep Quality Index score (PSQI) from baseline to 12 weeks [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.
- Change in Insomnia Severity Index score (ISI) from baseline to 12 weeks [Baseline and post-intervention, an average of 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.
- Change in Dysfunctional Beliefs About Sleep score (DBAS) from baseline to 12 weeks [Baseline and post-intervention, an average of 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.
- Change in Measures for coping with sleep disturbances score from baseline to 12 weeks [Baseline and post-intervention, an average of 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.
- Change in Worry about sleep score from baseline to 12 weeks [Baseline and post-intervention, an average of 12 weeks]
The Worry about sleep score ranges from 0 to 10, with greater scores indicating greater worry about sleep. The change in worry about sleep score from baseline to post-intervention (at 12 weeks) will be reported.
- Change in Patient Health Questionnaire-9 score (PHQ-9) from baseline to 12 weeks [Baseline to post-intervention, an average of 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.
- Change in PROMIS 6-item anxiety score from baseline to 12 weeks [Baseline and post-intervention, an average of 12 weeks]
The PROMIS 6-item anxiety score ranges from 6 to 30, with higher scores indicating more severe anxiety. The change in PROMIS 6-item anxiety score from baseline to post-intervention (at 12 weeks) will be reported.
- Change in Perceived Stress Scale score (PSS) from baseline to 12 weeks [Baseline and post-intervention, an average of 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnancy 12-28 weeks gestation at time of intervention start
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18 years of age or older
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Regular access to a web-enabled computer, phone or tablet
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Ability to read and speak English, and to provide informed consent
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Poor sleep quality (PSQI > 5)
Exclusion Criteria:
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Self-reported sleep disorder (e.g. sleep apnea, narcolepsy, parasomnia, circadian rhythm disorder)
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Shift-work or nighttime caregiving responsibilities
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Psychological, medical, or other issues that necessitate priority treatment (e.g. active suicidality, probable depression (PHQ-9 ≥ 10), psychosis, on bed rest, multiple gestation)
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Current regular mindfulness practice (>20 minutes/week)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94118 |
Sponsors and Collaborators
- University of California, San Francisco
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Jennifer N Felder, PhD, University of California, San Francisco
Study Documents (Full-Text)
More Information
Publications
None provided.- 20-32853
- K23AT009896