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OpenTrials
Completed

NCT Number: NCT05017974

Research on Improving Sleep During Pregnancy

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).

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Key information

Conditions

Sleep Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

About this study

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:

  • To determine acceptability of MBSR+PS.
  • To determine feasibility of MBSR+PS.
  • To determine adherence to MBSR+PS.
  • To explore evidence of change in psychological mediators.
  • To explore between-group differences in sleep.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement

Behavioral

MBSR+PS

Treatment as Usual

Other

TAU

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks

    Time frame: Baseline to post-intervention, an average of 12 weeks

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

  2. Number of Participants Completing Endpoint Measures at 12 Weeks

    Time frame: Post-intervention, an average of 12 weeks

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

  3. Completeness of Study Measures at Baseline and at 12 Weeks

    Time frame: 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.

  4. Percentage of MBSR and PS Sessions Attended

    Time frame: Baseline to post-intervention, an average of 12 weeks

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

  5. Frequency of Home Practices From Baseline to 12 Weeks

    Time frame: 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.

  6. Duration of Home Practices From Baseline to 12 Weeks

    Time frame: 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.

  7. Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks

    Time frame: 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.

  8. Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks

    Time frame: 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.

  9. Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks

    Time frame: 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.

  10. Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks

    Time frame: 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.

  11. Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks

    Time frame: 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.

  12. Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks

    Time frame: 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.

  13. Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks

    Time frame: 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.

  14. Change in Measures for Coping With Sleep Disturbances Score From Baseline to 12 Weeks

    Time frame: 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.

  15. Worry About Sleep Duration

    Time frame: Post-intervention, an average of 12 weeks

    Single item measure that assesses whether participants worried about not getting enough sleep in the past 2 weeks.

  16. Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks

    Time frame: 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.

  17. Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks

    Time frame: 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; 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

  18. Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Acronym: RISE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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