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Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms

NCT04445805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-01-19

No results posted yet for this study

Summary

The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these types of treatment will improve sleep and mood-related health risks in pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control.

Conditions

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBTI)

Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, cognitive therapy, and relaxation. Treatment will be delivered via telemedicine.

BEHAVIORAL

Perinatal-enhanced Behavioral Therapy for Insomnia

Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, and metacognitive exercises. Treatment will be delivered via telemedicine.

BEHAVIORAL

Attention Control

Will include education on sleep, circadian rhythms, and good sleep hygiene in addition to self-monitoring with sleep diaries.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • David Kalmbach, PhD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445805 on ClinicalTrials.gov