Online Prenatal Trial in Mindfulness Sleep Management

NCT04016428 | Completed DMC

• 2 other identifiers: STUDY000052675P30NR016585-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. This mindfulness intervention will also be compared with an online intervention (6 weeks) consisting only of education about insomnia in pregnancy. The principal hypothesis is that the mindfulness intervention will be more effective than the education-only intervention.

Conditions

Pregnancy Related; Insomnia; Depression

Keywords

sleep; pregnancy; insomnia; depression; mindfulness

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  Self-rating of overall sleep quality and disturbances using 7 sleep components. Total scores range from 0 to 21, with higher scores indicating worse sleep quality. PSQI global \>5 is highly sensitive and specific for distinguishing good and poor sleepers. A lower PSQI score is a better outcome.

  Enrollment to intervention completion (6 weeks)

Secondary Outcomes (14)

• Sleep efficiency

  Enrollment to intervention completion (6 weeks)

• Total wake time

  Enrollment to intervention completion (6 weeks)

• Total sleep time

  Enrollment to intervention completion (6 weeks)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form

  Enrollment to intervention completion (6 weeks)

• PROMIS Sleep-Related Impairment Short Form

  Enrollment to intervention completion (6 weeks)

Other Outcomes (4)

• PROMIS Self-Efficacy for Managing Emotions -- Short Form

  Enrollment to intervention completion (6 weeks)

• Index of Self-Regulation (ISR)

  Enrollment to intervention completion (6 weeks)

• Sleep Problem Acceptance Questionnaire (SPAQ)

  Enrollment to intervention completion (6 weeks)

Study Arms (2)

OPTIMISM Intervention

EXPERIMENTAL

Participants will receive online delivery of a mindfulness-based program for improving sleep in pregnancy, along with the usual care they would receive from their provider.

Behavioral: OPTIMISM

Sleep Education

ACTIVE COMPARATOR

Participants will receive online delivery of an education program on sleep in pregnancy, along with the usual care they would receive from their provider.

Behavioral: Sleep Education

Interventions

OPTIMISM BEHAVIORAL

Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.

OPTIMISM Intervention

Sleep Education BEHAVIORAL

Six-week online program that provides education on sleep during pregnancy.

Sleep Education

Eligibility Criteria

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

You may qualify if:

• \) Viable pregnancy in second trimester (up to 28 weeks gestation); 2) prior diagnosis of depression currently in remission (score \< 3 on the Patient Health Questionnaire (PHQ-2) depression screening questionnaire); 3) subjective report of insomnia (score \> 7 on the Insomnia Severity Index); 4) age 18 or older; 5) access to an Internet-enabled smartphone, tablet, or computer; and 6) English fluency. Participants will not be excluded from participation if they are currently receiving psychotropic medications or psychotherapy.

You may not qualify if:

• \) Known severe congenital fetal anomalies, fetal demise, or expected neonatal death; 2) diagnosis of major depressive disorder within past 2 months; 3) other significant psychiatric illness requiring treatment; 4) current hospitalization; 5) prior diagnosis of obstructive sleep apnea or restless leg syndrome; 6) positive self-report screen for restless leg syndrome; 7) regular mindfulness or meditative practice (at least weekly); and 8) regular night-shift work.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Wi D, Lee RY, Kantrowitz-Gordon I. Efficacy of online mindfulness for the treatment of insomnia in pregnancy: A randomized clinical trial. PLoS One. 2025 May 9;20(5):e0322931. doi: 10.1371/journal.pone.0322931. eCollection 2025.

  PMID: 40343904 DERIVED

• Kantrowitz-Gordon I, McCurry SM, Landis CA, Lee R, Wi D. Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Sep 14;6:128. doi: 10.1186/s40814-020-00675-1. eCollection 2020.

  PMID: 32944276 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Ira Kantrowitz-Gordon, PhD, CNM

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 11, 2019
• Study Start: July 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will become available 6 months after study start-up and will continue to be available throughout the study.
• Access Criteria: Steps to access data are available at https://cdrns.nih.gov/access-data

Locations

US (1)