Mind-Body Treatment for WTC Responders With Comorbid PTSD and Respiratory Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stony Brook University
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- Self-report WTC-related PTSD Symptoms
Study Overview
Brief Summary
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.
Detailed Description
Mind-body interventions including relaxation training and other coping skills are effective for patients with both mental and physical health problems. A leading mind-body treatment is the Relaxation Response Resiliency Program (3RP) developed at Harvard. This treatment has been shown to reduce both mental and physical health symptoms.
The objective of this study is to adapt the 3RP to WTC responders and test its ability to reduce both PTSD and respiratory symptoms. This treatment will be compared to a Health Enhancement Program that addresses negative health behaviors. The investigators will randomly assign 175 patients with ongoing WTC-related PTSD and respiratory illness to the 3RP or Health Enhancement Program and will assess outcomes immediately after the treatment and at 3 and 6 month follow-ups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Relaxation Response Resiliency Program
The Relaxation Response Resiliency Program (3RP) is an 8-session (90min/session) group based intervention which includes a variety of skills and techniques designed to address chronic stress. Techniques used include psychoeducation on healthy lifestyle behaviors, goal-setting, CBT skills, relaxation training and self-monitoring.
Intervention: Relaxation Response Resiliency Program (3RP) (Behavioral)
Health Enhancement Program
The Health Enhancement Program (HEP) is an 8-session (90min/session) group based intervention which includes psychoeducation and self-monitoring of health behaviors (e.g., sleep hygiene, nutrition, exercise, substance use etc).
Intervention: Health Enhancement Program (HEP) (Behavioral)
Outcomes
Primary Outcomes
Self-report WTC-related PTSD Symptoms
Time Frame: Change from baseline in WTC-related PTSD symptoms at 6-months
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Clinician Rated WTC-related PTSD Symptoms
Time Frame: Change from baseline in WTC-related PTSD symptoms at 6-months
Assessed via clinician interview (SCID for DSM-IV-TR).
Secondary Outcomes
- Lower Respiratory Symptoms(Change from baseline in lower respiratory symptoms at 6-months)
- Pulmonary Functioning(Change from baseline in pulmonary functioning at 6-months)