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Stress Management Program for World Trade Center (WTC) Responders

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02457780
Enrollment
157
Registered
2015-05-29
Start date
2013-08-31
Completion date
2016-12-31
Last updated
2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD, Signs and Symptoms, Respiratory

Keywords

PTSD, Trauma, World Trade Center, Respiratory, Mind-Body

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.

Interventions

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.

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.

Sponsors

National Institute for Occupational Safety and Health (NIOSH/CDC)
CollaboratorFED
Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-report WTC-related PTSD SymptomsChange from baseline in WTC-related PTSD symptoms at 6-monthsAssessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Clinician Rated WTC-related PTSD SymptomsChange from baseline in WTC-related PTSD symptoms at 6-monthsAssessed via clinician interview (SCID for DSM-IV-TR).

Secondary

MeasureTime frameDescription
Lower Respiratory SymptomsChange from baseline in lower respiratory symptoms at 6-monthsAssessed via self-report
Pulmonary FunctioningChange from baseline in pulmonary functioning at 6-monthsAssessed via spirometry

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026