Stress Management Program for World Trade Center (WTC) Responders

Not Applicable

Completed

• Conditions: PTSD; Signs and Symptoms, Respiratory
• Interventions: Behavioral: Relaxation Response Resiliency Program (3RP); Behavioral: Health Enhancement Program (HEP)

• Registration Number: NCT02457780
• Lead Sponsor: Stony Brook University

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation Response Resiliency Program	Relaxation Response Resiliency Program (3RP)	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.
Health Enhancement Program	Health Enhancement Program (HEP)	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).

Primary Outcome Measures

Name	Time	Method
Self-report WTC-related PTSD Symptoms	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	Change from baseline in WTC-related PTSD symptoms at 6-months	Assessed via clinician interview (SCID for DSM-IV-TR).

Secondary Outcome Measures

Name	Time	Method
Lower Respiratory Symptoms	Change from baseline in lower respiratory symptoms at 6-months	Assessed via self-report
Pulmonary Functioning	Change from baseline in pulmonary functioning at 6-months	Assessed via spirometry

Trial Locations

Locations (1)

Stony Brook University, Putnam Hall; 🇺🇸 Stony Brook, New York, United States