PTSD Clinical Trial
Official title:
Mind-Body Treatment for WTC Responders With Comorbid PTSD and Respiratory Illness
Verified date | December 2016 |
Source | Stony Brook University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Many responders to the World Trade Center (WTC) disaster continue to experience significant mental and physical health problems. Two of the most common health problems, post-traumatic stress disorder (PTSD) symptoms and respiratory illness, often occur together. Mental health conditions, such as PTSD, make physical illnesses worse and interfere with treatment. The primary goal of this study is to test a mind-body treatment designed to reduce both PTSD and respiratory symptoms.
Status | Completed |
Enrollment | 157 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - PCL score equal to or greater than 35 - 2 or more lower respiratory symptoms Exclusion Criteria: - Regular elicitation of the relaxation response - History of psychosis - Current unmanaged bipolar disorder - History of suicide attempt --OR-- current ideation with plan or intent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stony Brook University, Putnam Hall | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
Stony Brook University | National Institute for Occupational Safety and Health (NIOSH/CDC) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-report WTC-related PTSD Symptoms | Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S) | Change from baseline in WTC-related PTSD symptoms at 6-months | No |
Primary | Clinician Rated WTC-related PTSD Symptoms | Assessed via clinician interview (SCID for DSM-IV-TR). | Change from baseline in WTC-related PTSD symptoms at 6-months | No |
Secondary | Lower Respiratory Symptoms | Assessed via self-report | Change from baseline in lower respiratory symptoms at 6-months | No |
Secondary | Pulmonary Functioning | Assessed via spirometry | Change from baseline in pulmonary functioning at 6-months | No |
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