Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Research on Improving Sleep During Pregnancy (RISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05017974
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : September 22, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

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
Sleep Pregnancy Related Behavioral: Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement Other: Treatment as Usual Not Applicable

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:

  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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Mindfulness-based Stress Reduction Plus Prenatal Sleep Supplement Versus Usual Care: Acceptability, Feasibility, and Adherence
Actual Study Start Date : September 8, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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 [ 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 Outcome Measures :
  1. 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 [ Time Frame: 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.

  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.

  4. Among participants randomized to MBSR+PS, attendance of MBSR and PS supplement sessions from baseline to 12 weeks [ Time Frame: Baseline to post-intervention, an average of 12 weeks ]
    This measure will not be collected for participants randomized to TAU.

  5. Among participants randomized to MBSR+PS, 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. Among participants randomized to MBSR+PS, 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) from baseline to 12 weeks [ Time Frame: 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.

  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. Change in Worry about sleep score from baseline to 12 weeks [ Time Frame: 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.

  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. The change in PROMIS 6-item anxiety score from baseline to post-intervention (at 12 weeks) will be reported.

  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05017974


Contacts
Layout table for location contacts
Contact: Jennifer N Felder, PhD 415-476-7014 jennifer.felder@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94118
Contact: Jennifer Felder, PhD    415-476-7014    rise@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Layout table for investigator information
Principal Investigator: Jennifer N Felder, PhD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol  [PDF] May 17, 2021
Informed Consent Form  [PDF] July 26, 2021

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05017974    
Other Study ID Numbers: 20-32853
K23AT009896 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
pregnancy
sleep
mindfulness