Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2022-04-18
2022-11-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Project Women's Insomnia Sleep Health Equity Study (WISHES)
NCT06348082
Electrophysiologic Changes in Blacks Treated With CBT for Insomnia
NCT02741336
Reduce Emotional Symptoms of Insomnia With SleepTreatment
NCT03724305
Mindfulness-Based Approaches to Insomnia
NCT00768781
Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
NCT03949296
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mindfulness-based therapy for insomnia (MBTI)
Participants randomly assigned to the MBTI will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
Mindfulness-based therapy for insomnia (MBTI)
Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
Healthy Lifestyle Education
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.
Healthy lifestyle intervention
Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfulness-based therapy for insomnia (MBTI)
Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
Healthy lifestyle intervention
Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 25-45 years old
* English speaking
* 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)
Exclusion Criteria
* significant current practice of any form of meditation (\>15min per day)
* obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, pregnancy, use of medication that influence circadian rhythm, e.g., Parkinson's disease)
* other medical conditions that confound salivary biomarkers outcomes (e.g., radiation of salivary glands, Cushing or Addison's disease)
* active or terminal cancer
25 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale University - West Campus
Orange, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2000030653
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.