Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems

Phase 1

Completed

• Conditions: Sleep Problems; Inflammation

• Registration Number: NCT01534338
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The primary aim of the study is to test the effect of mindfulness training on sleep parameters among older adults with insomnia symptoms

The secondary aims are to examine if changes in mindfulness meditation practice (daily log) and level of mindfulness (self-report) are associated with changes in sleep parameters, and to determine if mindfulness training is associated with in vitro biological markers of peripheral inflammation

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-16
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Men and women (all races and ethnicities) 55 years of age and older
• Have current problems sleeping
• Fluent in English
• Able to understand and provide signed informed consent
• Willing to be randomly assigned to treatment condition

Exclusion Criteria

• Individuals currently undergoing major medical treatment such as surgery, radiation, or immunotherapy
• Individuals living outside of a 20 mile radius from the UCLA Medical Center
• Individuals with current substance dependence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep	Within 2 weeks post-intervention	Primary sleep outcomes to be assessed include Daily sleep diary, Pittsburgh Sleep Quality Index, Fatigue Symptom Inventory, Insomnia Severity Index, and Pre-Sleep Arousal Scale

Secondary Outcome Measures

Name	Time	Method
Mindfulness	Within 2 weeks post-intervention	Mindfulness will be assessed by self report with the Five Facet Mindfulness Questionnaire and a daily log of amount of mindfulness practice
Inflammatory Biology	Within 2 weeks post-intervention	Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture collected between 9am and 1130am

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States