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Stress Management Program for World Trade Center (WTC) Responders

Primary Purpose

PTSD, Signs and Symptoms, Respiratory

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Response Resiliency Program (3RP)
Health Enhancement Program (HEP)
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Trauma, World Trade Center, Respiratory, Mind-Body

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stony Brook University, Putnam Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Relaxation Response Resiliency Program

Health Enhancement Program

Arm 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.

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).

Outcomes

Primary Outcome Measures

Self-report WTC-related PTSD Symptoms
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Clinician Rated WTC-related PTSD Symptoms
Assessed via clinician interview (SCID for DSM-IV-TR).

Secondary Outcome Measures

Lower Respiratory Symptoms
Assessed via self-report
Pulmonary Functioning
Assessed via spirometry

Full Information

First Posted
May 4, 2015
Last Updated
December 21, 2016
Sponsor
Stony Brook University
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
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1. Study Identification

Unique Protocol Identification Number
NCT02457780
Brief Title
Stress Management Program for World Trade Center (WTC) Responders
Official Title
Mind-Body Treatment for WTC Responders With Comorbid PTSD and Respiratory Illness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Signs and Symptoms, Respiratory
Keywords
PTSD, Trauma, World Trade Center, Respiratory, Mind-Body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation Response Resiliency Program
Arm Type
Experimental
Arm 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.
Arm Title
Health Enhancement Program
Arm Type
Active Comparator
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response Resiliency Program (3RP)
Other Intervention Name(s)
Stress Management and Resiliency Training (SMART)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Enhancement Program (HEP)
Intervention Description
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 Outcome Measure Information:
Title
Self-report WTC-related PTSD Symptoms
Description
Assessed via self-report (PTSD Checklist Specific Stressor; PCL-S)
Time Frame
Change from baseline in WTC-related PTSD symptoms at 6-months
Title
Clinician Rated WTC-related PTSD Symptoms
Description
Assessed via clinician interview (SCID for DSM-IV-TR).
Time Frame
Change from baseline in WTC-related PTSD symptoms at 6-months
Secondary Outcome Measure Information:
Title
Lower Respiratory Symptoms
Description
Assessed via self-report
Time Frame
Change from baseline in lower respiratory symptoms at 6-months
Title
Pulmonary Functioning
Description
Assessed via spirometry
Time Frame
Change from baseline in pulmonary functioning at 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Gonzalez, PhD
Organizational Affiliation
Stony Brook University Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University, Putnam Hall
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

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Stress Management Program for World Trade Center (WTC) Responders

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