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Enhanced Behavioral Therapy for Insomnia (INSPIRE Trial)

N/A
Waitlist Available
Led By David Kalmbach, PhD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Awards & highlights

INSPIRE Trial Summary

This trial will study whether telemedicine treatments can help improve sleep and mood for pregnant women.

Who is the study for?
This trial is for pregnant women under 28 weeks gestation, aged 18-40, with significant insomnia (score >10 on the Insomnia Severity Index). They must have a reliable internet connection for telemedicine sessions. Excluded are those with high-risk pregnancies, active suicidal intent, shift work schedules, language barriers or other issues preventing engagement in study activities.Check my eligibility
What is being tested?
The study tests whether cognitive behavioral therapy (CBTI) and mindfulness-based therapy (MBTI) via telemedicine can improve sleep and reduce mood-related health risks during pregnancy and after birth compared to basic sleep education. Participants will receive one of these treatments remotely.See study design
What are the potential side effects?
As this trial involves non-pharmacological interventions like CBTI and MBTI, side effects may include discomfort from discussing personal issues or temporary increases in distress as coping strategies are learned.

INSPIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of mindfulness based therapy for insomnia for changes in insomnia symptoms - Insomnia Severity Index (ISI)
Secondary outcome measures
Effectiveness of mindfulness based therapy for insomnia for changes in cognitive arousal - Presleep Arousal Scale-Cognitive Factor
Effectiveness of mindfulness based therapy for insomnia for changes in depression symptoms- Edinburgh Postnatal Depression Scale (EPDS)

INSPIRE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Perinatal-enhanced behavioral therapy for insomniaExperimental Treatment1 Intervention
Telemedicine Mindfulness Based Therapy for Insomnia (MBTI)
Group II: CBTI Treatment GroupActive Control1 Intervention
Telemedicine Cognitive Behavioral Therapy for Insomnia (CBTI)
Group III: Attention Control Treatment GroupPlacebo Group1 Intervention
Minimal intervention control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perinatal-enhanced Behavioral Therapy for Insomnia
2021
N/A
~70

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,935 Total Patients Enrolled
9 Trials studying Insomnia
1,159 Patients Enrolled for Insomnia
David Kalmbach, PhDPrincipal Investigator - Henry Ford Health System
Henry Ford Health System
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Insomnia
12 Patients Enrolled for Insomnia

Media Library

Cognitive Behavioral Therapy for Insomnia (CBTI) Clinical Trial Eligibility Overview. Trial Name: NCT04445805 — N/A
Insomnia Research Study Groups: CBTI Treatment Group, Attention Control Treatment Group, Perinatal-enhanced behavioral therapy for insomnia
Insomnia Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia (CBTI) Highlights & Side Effects. Trial Name: NCT04445805 — N/A
Cognitive Behavioral Therapy for Insomnia (CBTI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04445805 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research have an age limit, and if so, what is it?

"This medical trial is open for enrolment to individuals aged 18-40. Those below the age of majority or over 65 have 24 and 180 studies available respectively."

Answered by AI

Has enrollment for this experiment commenced?

"According to clinicaltrials.gov, this medical investigation is not currently enrolling patients; it was initially posted on March 15th 2021 and the last update occurred September 16th 2022. Yet, there are still 229 other studies recruiting subjects right now."

Answered by AI

Are there any specific criteria for volunteers of this investigation?

"This clinical trial has an enrollment capacity of 120 individuals aged 18 to 40 suffering from insomnia. Entry requirements include a gestational age lower than 28 weeks, an Insomnia Severity Index score greater than 10, reliable internet connection for telemedicine-based treatment and assessment."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Henry Ford Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
David Kalmbach 2021. "Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04445805.
~16 spots leftby Apr 2025
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