Research on Improving Sleep During Pregnancy

NCT05017974 | Completed Results DMC

• 2 other identifiers: 20-32853K23AT009896
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep; Pregnancy Related

Keywords

pregnancy; sleep; mindfulness

Outcome Measures

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

  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.

  Post-intervention, an average of 12 weeks

Secondary Outcomes (18)

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

  Baseline to post-intervention, an average of 12 weeks

• Number of Participants Completing Endpoint Measures at 12 Weeks

  Post-intervention, an average of 12 weeks

• Completeness of Study Measures at Baseline and at 12 Weeks

  Baseline and post-intervention, an average of 12 weeks

• Percentage of MBSR and PS Sessions Attended

  Baseline to post-intervention, an average of 12 weeks

• Frequency of Home Practices From Baseline to 12 Weeks

  Baseline to post-intervention, an average of 12 weeks

Study Arms (2)

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS)

EXPERIMENTAL

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; Other: Treatment as Usual

Treatment as Usual

OTHER

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

Interventions

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement BEHAVIORAL

MBSR+PS

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS)

Treatment as Usual OTHER

TAU

Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement (MBSR+PS); Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy 12-28 weeks gestation at time of intervention start
• 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 may not qualify 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction; Therapeutics

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Jennifer Felder
• Organization: University of California, San Francisco

jennifer.felder@ucsf.edu

415-476-7014

Study Officials

• Jennifer N Felder, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: September 8, 2021
• Primary Completion: June 29, 2022
• Study Completion: July 14, 2022
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)