Stress Management Program for World Trade Center (WTC) Responders

Stony Brook University

Status: Completed

Conditions: PTSD; Signs and Symptoms, Respiratory

Treatments: Behavioral: Health Enhancement Program (HEP); Behavioral: Relaxation Response Resiliency Program (3RP)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02457780

1U01OH010524-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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157 participants in 2 patient groups

Relaxation Response Resiliency Program

Experimental group

Description:

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.

Treatment:

Behavioral: Relaxation Response Resiliency Program (3RP)

Health Enhancement Program

Active Comparator group

Description:

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).

Treatment:

Behavioral: Health Enhancement Program (HEP)