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| Name | Class |
|---|---|
| National Institute for Occupational Safety and Health (NIOSH/CDC) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relaxation Response Resiliency Program | Experimental | 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. |
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| Health Enhancement Program | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation Response Resiliency Program (3RP) | Behavioral | The 3RP is designed to decrease psychiatric and physical health symptoms and build resiliency by teaching skills to (1) elicit the relaxation response, (2) decrease stress reactivity and (3) increase social connectedness. Eliciting the relaxation response involves sustained mental focus with an attitude of receptive awareness with strategies aimed at reducing muscle tension, breathing rate, heart rate, and blood pressure. Decreasing stress reactivity involves increasing awareness of the stress response and learning skills to proactively address stress. Increasing connectedness involves skills to promote positive growth, self-efficacy and social support. Other skills and experiential exercises focus on increasing acceptance, optimism, empathy, and appreciation to promote resiliency. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Respiratory Symptoms | Assessed via self-report | Change from baseline in lower respiratory symptoms at 6-months |
| Pulmonary Functioning | Assessed via spirometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Gonzalez, PhD | Stony Brook University Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University, Putnam Hall | Stony Brook | New York | 11794 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D012818 | Signs and Symptoms, Respiratory |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
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| Health Enhancement Program (HEP) | Behavioral | The HEP is designed to address comorbid physical and mental health symptoms via psychoeducation, self-monitoring and goal setting techniques. It is an 8 session manualized group intervention which addresses topics including sleep hygiene, nutrition, exercise, working with a healthcare team, and substance use. The program uses a variety of in-session activities to engage participants in discussion related to self-care and wellness principles. Relapse prevention and long-term goal setting are addressed. The program is designed to be implemented by professionals with a background in mental health. |
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| Change from baseline in pulmonary functioning at 6-months |
| D013568 | Pathological Conditions, Signs and Symptoms |