Stress Management Program for World Trade Center (WTC) Responders

Mind-Body Treatment for WTC Responders With Comorbid PTSD and Respiratory Illness

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Signs and Symptoms, Respiratory
• Intervention / Treatment: Behavioral: Relaxation Response Resiliency Program (3RP); Behavioral: Health Enhancement Program (HEP)

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 Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University, Putnam Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Relaxation Response Resiliency Program (3RP); 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.; Other Names: Stress Management and Resiliency Training (SMART)
Active Comparator: 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).	Behavioral: Health Enhancement Program (HEP); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Change from baseline in pulmonary functioning at 6-months

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: National Institute for Occupational Safety and Health (NIOSH/CDC)
• Investigators: Principal Investigator: Adam Gonzalez, PhD, Stony Brook University Department of Psychiatry

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 26, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: PTSD; Trauma; Respiratory; World Trade Center; Mind-Body
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory
• Other Study ID Numbers: 1U01OH010524-01 (U.S. NIH Grant/Contract)