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Completed

NCT Number: NCT02457780

Stress Management Program for World Trade Center (WTC) Responders

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.

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Key information

Conditions

PTSD Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University, Putnam Hall

Stony Brook, New York, 11794, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Stress Management and Resiliency Training (SMART)

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.

Primary outcomes

  1. 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)

  2. 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

  1. Lower Respiratory Symptoms

    Time frame: Change from baseline in lower respiratory symptoms at 6-months

    Assessed via self-report

  2. Pulmonary Functioning

    Time frame: Change from baseline in pulmonary functioning at 6-months

    Assessed via spirometry

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • National Institute for Occupational Safety and Health (NIOSH/CDC)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 29, 2015
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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