Clinical Trials Directory

Trials / Completed

CompletedNCT02457780

Stress Management Program for World Trade Center (WTC) Responders

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
157 (actual)
Sponsor
Stony Brook University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRelaxation 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.
BEHAVIORALHealth 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.

Timeline

Start date
2013-08-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2015-05-29
Last updated
2016-12-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02457780. Inclusion in this directory is not an endorsement.