View Clinical Trial (Medical Research Study)
Evaluation of Yoga for Sleep Disturbances in Insomnia and Posttraumatic Stress Disorder
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Boston |
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Massachusetts |
| Zip Code: |
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02116 |
| Conditions: |
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Post Traumatic Stress Disorder - Insomnia |
| Purpose: |
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The primary objective of this preliminary study is to estimate sleep outcome effect sizes
and determine feasibility for a novel yoga treatment of insomnia in participants with post
traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of
sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible
mechanisms of action.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Male and non-pregnant female adults at least 18 years of age.
- A DSM-IV-TR diagnosis of post-traumatic stress disorder (PTSD).
- Naïve to yoga and other meditative practices, defined as less than one hour per week
for the past 6 months.
- Potential subjects receiving ongoing medical or psychological treatment are eligible,
as long as treatment remains stable over the course of the study and does not include
more than one hour weekly of mind-body medicine (strategies directly related to
meditation and yoga).
- No more than 2 alcoholic or caffeinated drinks/day
- No illicit drug use
- Potential subjects are eligible if they have been on stable dosage (not PRN) of
medication for PTSD symptoms including sleep disturbances and any medication that may
influence sleep for at least 6 weeks prior to the study, and be willing to continue
with same dosage for the duration of the study.
- No current substance abuse, defined as diagnosis of substance abuse or dependence
disorder within the past year, and/or in/outpatient treatment for substance abuse or
dependence in the past 6 weeks.
- No transcontinental travel over the course of the study.
- No night-shift or rotating shift work over the course of the study.
- Insomnia based on the American Academy of Sleep Medicine's Research Diagnostic
Criteria (RDC) for insomnia due to a mental health disorder
- Potential subjects are eligible to participate in this study if they have sufficient
mental and physical ability to fully participate in the parameters of the study.
Subjects must be able to understand and comply with instructions in the group yoga
sessions and home practice, complete questionnaires, participate in clinical
interviews, and take part in all data collection activities. Subjects with severe
mental or physical concerns that may prevent them from understanding and/or complying
with the treatment will be excluded. For example, potential subjects confined to
wheelchairs will not be eligible, although subjects with artificial limbs who are
able to reasonably participate in the intervention may be deemed eligible. These
determinations will be made during discussions with potential subjects on a case by
case basis during the screening process.
Exclusion Criteria:
- Potential subjects are ineligible if pregnant.
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| NCT ID: |
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NCT01556074 |
| Primary Contact: |
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Principal Investigator
Jessica J Noggle, PhD
Brigham and Women's Hospital
Jessica J Noggle, PhD
Phone: 617-800-9164
Email: PTSDinsomnia@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02116
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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