Stress Management Program for World Trade Center (WTC) Responders

NCT02457780 | Completed

• 1 other identifier: 1U01OH010524-01
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Signs and Symptoms, Respiratory

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Lower Respiratory Symptoms

  Change from baseline in lower respiratory symptoms at 6-months

• Pulmonary Functioning

  Change from baseline in pulmonary functioning at 6-months

Study Arms (2)

Relaxation Response Resiliency Program

EXPERIMENTAL

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.

Behavioral: Relaxation Response Resiliency Program (3RP)

Health Enhancement Program

ACTIVE COMPARATOR

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).

Behavioral: Health Enhancement Program (HEP)

Interventions

Relaxation Response Resiliency Program (3RP) BEHAVIORAL

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.

Also known as: Stress Management and Resiliency Training (SMART)

Relaxation Response Resiliency Program

Health Enhancement Program (HEP) BEHAVIORAL

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.

Health Enhancement Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PCL score equal to or greater than 35
• or more lower respiratory symptoms

You may not qualify if:

• Regular elicitation of the relaxation response
• History of psychosis
• Current unmanaged bipolar disorder
• History of suicide attempt --OR-- current ideation with plan or intent

Sponsors & Collaborators

• Stony Brook University: lead
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator

Study Sites (1)

Stony Brook University, Putnam Hall

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Signs and Symptoms, Respiratory; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam Gonzalez, PhD

  Stony Brook University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 29, 2015
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

US (1)