Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
INSPIRE
The INSPIRE Trial: Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 19, 2024
January 1, 2024
2.8 years
June 19, 2020
January 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of mindfulness based therapy for insomnia 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.
Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Secondary Outcomes (2)
Effectiveness of mindfulness based therapy for insomnia for changes in depression symptoms- Edinburgh Postnatal Depression Scale (EPDS)
Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Effectiveness of mindfulness based therapy for insomnia for changes in cognitive arousal - Presleep Arousal Scale-Cognitive Factor
Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Study Arms (3)
CBTI Treatment Group
ACTIVE COMPARATORTelemedicine Cognitive Behavioral Therapy for Insomnia (CBTI)
Perinatal-enhanced behavioral therapy for insomnia
EXPERIMENTALTelemedicine Mindfulness Based Therapy for Insomnia (MBTI)
Attention Control Treatment Group
PLACEBO COMPARATORMinimal intervention control
Interventions
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.
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.
Will include education on sleep, circadian rhythms, and good sleep hygiene in addition to self-monitoring with sleep diaries.
Eligibility Criteria
You may qualify if:
- (1) Gestational age at time of study enrollment must be less than or equal to 28 weeks
- (2) Insomnia Severity Index score \> 10
- (3) age 18 - 40 years
- (4) reliable and adequately fast internet connection at home, which is required to engage in telemedicine treatment (online video) and online study outcome assessments.
You may not qualify if:
- High risk pregnancy (e.g., pre-eclampsia, multiple pregnancy, age\>40)
- Bipolar disorder (contraindicated for CBTI)
- Seizures (contraindicated for CBTI)
- Active suicidal intent
- Shift work
- Patients who cannot reasonably engage in study activities including treatment or completing online surveys will be excluded regardless of reason. This may include inability to comprehend the English language, inability to hear therapist over video sessions, inability to understand and meaningfully answer study outcomes measures, or other barriers to participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Medical Center
Novi, Michigan, 48377, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Kalmbach, PhD
Henry Ford Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Bioscientific Staff Researcher
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 24, 2020
Study Start
March 15, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 19, 2024
Record last verified: 2024-01