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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02457780
Other study ID # 1U01OH010524-01
Secondary ID
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


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
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