Research on Improving Sleep During Pregnancy

NCT ID: NCT05017974

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2022-07-14

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.

Conditions

Sleep; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement

Intervention Type: BEHAVIORAL

MBSR+PS

Treatment as Usual

Intervention Type: OTHER

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.

Group Type: OTHER

Treatment as Usual

Intervention Type: OTHER

TAU

Interventions

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement

MBSR+PS

Intervention Type: BEHAVIORAL

Treatment as Usual

TAU

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer N Felder, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23AT009896

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-32853

Identifier Type: -

Identifier Source: org_study_id