Clinical trial NCT05017974: Research on Improving Sleep During Pregnancy
Official title: Randomized Controlled Trial of Mindfulness-based Stress Reduction Plus Prenatal Sleep Supplement Versus Usual Care: Acceptability, Feasibility, and Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Pregnancy Related
Keywords: pregnancy
sleep
mindfulness
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-08-24
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: Post-intervention, an average of 12 weeks
Secondary outcomes:
measure: Number of Participants Who Attend at Least One Session of MBSR and the PS Supplement From Baseline to 12 Weeks
timeFrame: Baseline to post-intervention, an average of 12 weeks
measure: Number of Participants Completing Endpoint Measures at 12 Weeks
timeFrame: Post-intervention, an average of 12 weeks
measure: Completeness of Study Measures at Baseline and at 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Percentage of MBSR and PS Sessions Attended
timeFrame: Baseline to post-intervention, an average of 12 weeks
measure: Frequency of Home Practices From Baseline to 12 Weeks
timeFrame: Baseline to post-intervention, an average of 12 weeks
measure: Duration of Home Practices From Baseline to 12 Weeks
timeFrame: Baseline to post-intervention, an average of 12 weeks
measure: Change in Self Compassion Scale - Short Form (SCS-SF) From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Change in Five-Facet Mindfulness Questionnaire (FFMQ) Nonjudging and Nonreactivity Factors From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Change in Coping Strategies Questionnaire - Revised (CSQ-R) From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Change in Rumination-Reflection Questionnaire (RRQ) From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Change in Pittsburgh Sleep Quality Index Score (PSQI) From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Change in Insomnia Severity Index Score (ISI) From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Change in Dysfunctional Beliefs About Sleep Score (DBAS) From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Change in Measures for Coping With Sleep Disturbances Score From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Worry About Sleep Duration
timeFrame: Post-intervention, an average of 12 weeks
measure: Change in Patient Health Questionnaire-9 Score (PHQ-9) From Baseline to 12 Weeks
timeFrame: Baseline to post-intervention, an average of 12 weeks
measure: Change in PROMIS 6-item Anxiety Score From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
measure: Change in Perceived Stress Scale Score (PSS) From Baseline to 12 Weeks
timeFrame: Baseline and post-intervention, an average of 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jennifer N Felder, PhD
role: PRINCIPAL_INVESTIGATOR
References: