A Phase 1/2 interventional study of Mind-Body Bridging Program and Sleep Hygiene in Insomnia, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-24.
Sponsored by University of Utah · Phase 1/2, Interventional, and Treatment
The first part of the pilot study, as detailed in Unique Protocol ID No. 27522, is a randomized clinical trial that compares the effects of a mind-body bridging program with a sleep hygiene program to improve sleep quality in patients suffering from sleep disturbances. In Part II of the study, the investigators will perform a six month follow-up on the same subjects.
In this follow-up, we ask subjects to answer the same questionnaires that they completed at the beginning of the study. In addition we will ask subjects to complete a survey reflecting their medical history over the past 6 months and a second survey establishing their behavioral patterns and whether they continued practicing techniques of the intervention they were assigned to.
University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mind Body Bridging subjects will be accessed with questionnaires and medical history evaluations for the impact of MBBP over the past 6 months since undertaking the program.
Behavioral: Mind-Body Bridging Program
Sleep Hygiene subjects will be accessed with questionnaires and medical history evaluations for the impact of SH over the past 6 months since undertaking the program.
Behavioral: Sleep Hygiene
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Also known as: MBBP
treatment as usual
Also known as: SH
Medical Outcomes Study-Sleep Scale
Time frame: 6 months following study part I
Medical Outcomes Study Short Form-36
Time frame: 6 months following study part I
Center for Epidemiologic Studies Depression Scale
Time frame: 6 months following study part I
Five-factor Mindfulness Questionnaire
Time frame: 6 months following study part I
PTSD Check List-Military
Time frame: 6 months following study part I
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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University of Utah