Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Jennifer N Felder, PhD
Photo of Jennifer N Felder
Jennifer N Felder

Description

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).

Official Title

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

Details

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.

Keywords

Sleep Pregnancy Related pregnancy mindfulness Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS)

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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)

You CAN'T join if...

  • 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)

Location

  • University of California, San Francisco
    San Francisco California 94118 United States

Lead Scientist at UCSF

  • Jennifer N Felder, PhD
    Jennifer Felder, PhD, is a licensed clinical psychologist dedicated to promoting women’s health during pregnancy and early parenting (i.e., the perinatal period). She optimizes interventions to improve psychological, behavioral, and physical health outcomes, such as depression, sleep, and preterm birth. She primarily focuses on targeting novel risk factors for depression.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05017974
Study Type
Interventional
Last Updated