Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.

NCT04443959 | Completed

• 1 other identifier: PPD2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Over half of pregnant and postpartum women experience clinical insomnia. However, treatment options are very limited for pregnant women and moms of newborns. Sleep aids are not considered safe during pregnancy and may increase risks about safety for mom and baby during postpartum. Recent clinical trials show that behavioral and mindfulness-based treatments can safely improve sleep and mood during pregnancy. Yet, no published studies to date have combined behavioral sleep treatment with mindfulness-based stress reduction to improve sleep and mood at the same time in pregnant and postpartum women. This study is the first to combine behavioral sleep strategies with mindfulness-meditation to improve sleep and psychological wellbeing of expecting and new moms. The purpose of this research study is to examine the effectiveness of a mindfulness-based intervention for prenatal insomnia via telemedicine format to improve sleep and mood as well as reduce stress in pregnant women.

Conditions

Insomnia

Keywords

Mindfulness; Cognitive arousal; insomnia; pregnant; perinatal

Outcome Measures

Primary Outcomes (1)

• Effectiveness of PUMAS for changes in insomnia symptoms - Insomnia Severity Index (ISI)

  The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia. ISI scores \< 8 after treatment indicate remission.

  Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).

Secondary Outcomes (2)

• Effectiveness of PUMAS for changes in depressive symptoms

  Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).

• Effectiveness of PUMAS for changes in of cognitive arousal- Presleep Arousal Scale- Cognitive Factor

  Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).

Study Arms (1)

PUMAS Treatment

EXPERIMENTAL

Prenatal insomnia program that places behavioral sleep strategies within a mindfulness-based intervention framework that is geared toward pregnant women.

Behavioral: PUMAS

Interventions

PUMAS BEHAVIORAL

Treatment consists of 6 weekly telemedicine sessions during pregnancy.

PUMAS Treatment

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (1) Gestational age at time of study enrollment must be 18-30 weeks.
• (2) Insomnia Severity Index score of 11 or higher
• (3) age between 18 and 40 years
• (4) reliable and adequately fast internet connection at home, which is required to engage in online treatment and online study outcome assessments

You may not qualify if:

• (1) High risk pregnancy as reported by the patient, which includes but is not limited to pre-eclampsia, gestational diabetes, maternal age \> 40, ectopic pregnancy, fetal problems (e.g., heart problems), hyperemesis gravidarum, placenta previa, and placental abruption.
• (2) bipolar disorder or seizure disorders \[contraindicated for insomnia therapy\] as reported by the patient
• (3) women with multiple pregnancy (e.g., twins, triplets, etc.) will not be eligible to participate as multiple pregnancy can increase risk of complications and often leads to preterm or early-term birth
• (4) any conditions or difficulties that would prevent the patient from completing online treatment and/or online surveys, including but not limited to language difficulties, literacy issues, visual or auditory impairment, and cognitive deficits
• (5) active suicidal intent

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Medical Center

Novi, Michigan, 48377, United States

Location

Related Publications (2)

• Kalmbach DA, Cheng P, Reffi AN, Ong JC, Swanson LM, Espie CA, Seymour GM, Hirata M, Walch O, Pitts DS, Roth T, Drake CL. Reducing cognitive arousal and sleep effort alleviates insomnia and depression in pregnant women with DSM-5 insomnia disorder treated with a mindfulness sleep program. Sleep Adv. 2023 Aug 5;4(1):zpad031. doi: 10.1093/sleepadvances/zpad031. eCollection 2023.

  PMID: 37645455 DERIVED

• Kalmbach DA, Cheng P, Reffi AN, Ong JC, Swanson LM, Fresco DM, Walch O, Seymour GM, Fellman-Couture C, Bayoneto AD, Roth T, Drake CL. Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy. Sleep Med. 2023 Aug;108:79-89. doi: 10.1016/j.sleep.2023.05.026. Epub 2023 Jun 10.

  PMID: 37343335 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• David Kalmbach, PhD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bioscientific Staff Researcher

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: August 15, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

US (1)