A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)

The objective of this protocol is to test the feasibility and acceptability of the Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower respiratory symptoms (LRS) and improve psychosocial functioning.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: 3 RP

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• score > or = 44 on the PTSD Checklist PCL, considered the broad definition of PTSD syndrome71
• report at least one LRS symptoms (i.e., shortness of breath, wheezing, dyspnea or cough).
• Spanish Speaking

Exclusion Criteria:

• regular practice of eliciting relaxation response (i.e., meditation, yoga) in the past 6 months,
• serious unmanaged mental illness including bipolar disorder, psychosis, and active substance misuse disorders;
• inability to participate in consecutive sessions over 3-month period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relaxation Response Resiliency Program (3RP)	Behavioral: 3 RP; Other Names: Relaxation Response Resiliency Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV	State-of-the-art instrument for obtaining psychiatric diagnoses.	1 Month
Symptom Severity using PTSD Checklist	Symptoms will be assessed with the PTSD Checklist (PCL), a 17-item self-report measure of current (past month) PTSD symptoms based on the DSM-IV criteria. It is a widely-used and validated measure of PTSD symptom severity.	1 Month
Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)		1 Month
Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT)	widely-used instrument that taps the domains of work, household duties, interpersonal relationships, recreation, and subjective satisfaction with life. Each domain is rated on a five-point scale from very good to very poor. The total score is the sum of the different domains.	1 Month
Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS)	The MAAS is a 15-item questionnaire on which respondents indicate, on a 6 point Likert-type scale (1 = almost always to 6 = almost never), their level of awareness and attention to present events and experiences.	1 Month
Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II)	he HPLP-II is a 52 item self-report inventory of health behaviors and has been used in previous mind-body treatment studies	1 Month
Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire.	The 6-item Treatment Credibility/Expectancy Questionnaire (CEQ)84 will be used to examine treatment expectancy related to the 3RP.	1 Month

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Lucia Ferri, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): October 11, 2017
• Study Completion (Actual): October 11, 2017

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 15-00721