Stress Management Program for World Trade Center (WTC) Responders

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457780
• Other study ID #: 1U01OH010524-01
• Status: Completed
• Phase: N/A
• First received: May 4, 2015
• Last updated: December 21, 2016
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD
• Signs and Symptoms
• Signs and Symptoms, Respiratory

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stony Brook University, Putnam Hall	Stony Brook	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Lower Respiratory Symptoms	Assessed via self-report	Change from baseline in lower respiratory symptoms at 6-months	No
Secondary	Pulmonary Functioning	Assessed via spirometry	Change from baseline in pulmonary functioning at 6-months	No