← Back to Search

Behavioral Intervention

Mindfulness-based therapy for insomnia (MBTI) for Insomnia

N/A
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
meeting DSM-5/ICSD3 diagnostic criteria for insomnia disorders defined as difficulty initiating or maintaining sleep with at least one associated daytime impairment symptom (Insomnia severity index > 7)
self-identified Black women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial will study whether Mindfulness Based Therapy for Insomnia (MBTI) is an effective treatment for insomnia in black women, and whether it is feasible and acceptable to them.

Eligible Conditions
  • Insomnia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Fidelity
Change in Insomnia severity score
Change in perceived stress score (PSS)
+6 more
Secondary outcome measures
Change in C-reactive protein [CRP]
Change in Cortisol
Change in Five Facet Mindfulness Questionnaire (FFMQ)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-based therapy for insomnia (MBTI)Experimental Treatment1 Intervention
Participants randomly assigned to the MBTI will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
Group II: Healthy Lifestyle EducationActive Control1 Intervention
Participants in the control group will receive sessions on the following topics: Introduction to health promotion, disease prevention and screening, healthy eating, physical activity, communication, and endings.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-based therapy for insomnia (MBTI)
2022
N/A
~30

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,836 Previous Clinical Trials
2,727,243 Total Patients Enrolled
5 Trials studying Insomnia
136 Patients Enrolled for Insomnia

Frequently Asked Questions

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

Who is qualified to partake in this trial?

"We are seeking 30 individuals with the sleep disorder, insomnia, ranging from 25 to 45 years old. Preference will be given to Black women who demonstrate fluency in English and meet DSM-5/ICSD3 criteria for insomnia (Insomnia Severity Index > 7) with at least 1 associated symptom causing daytime impairment."

Answered by AI

How many participants are being accepted into this medical experiment?

"Affirmative. According to the details displayed on clinicaltrials.gov, this medical research project is actively searching for participants since it was posted on April 18th 2022 and updated recently on May 26th 2022. At present, 30 patients are needed from one trial location."

Answered by AI

Are mature adults eligible to participate in this experiment?

"This medical investigation is searching for individuals between 25 and 45 years old."

Answered by AI

Is this trial currently open to new participants?

"Yes, according to records published on clinicaltrials.gov this medical study is recruiting patients. On April 18th 2022 the trial was initially posted and has since been updated as recently as May 26th of this year. The research team are intending to enroll 30 participants at 1 location."

Answered by AI

What is the ultimate goal of this research endeavor?

"This trial is designed to evaluate the efficacy of a new intervention by measuring changes in Five Facet Mindfulness Questionnaire (FFMQ) scores over time. Secondary outcome metrics entail evaluating alterations in Insomnia severity score, wake after sleep onset duration, and C-reactive protein [CRP] concentrations with criteria for meaningful change or remission specified as follows: 7+ point decrease on ISI scale; reduction of WASO minutes; 25 - 1600 pg/ml range for CRP test volume results."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
~10 spots leftby Mar 2025