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

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder (PTSD)
• Interventions: Behavioral: 3 RP

• Registration Number: NCT02723097
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-30
• Status Verified: 2017-10
• Primary Completion: 2017-10-11
• Study Completion: 2017-10-11
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Relaxation Response Resiliency Program (3RP)	3 RP	-

Primary Outcome Measures

Name	Time	Method
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV	1 Month	State-of-the-art instrument for obtaining psychiatric diagnoses.
Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II)	1 Month	he HPLP-II is a 52 item self-report inventory of health behaviors and has been used in previous mind-body treatment studies
Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)	1 Month
Symptom Severity using PTSD Checklist	1 Month	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.
Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT)	1 Month	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.
Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire.	1 Month	The 6-item Treatment Credibility/Expectancy Questionnaire (CEQ)84 will be used to examine treatment expectancy related to the 3RP.
Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS)	1 Month	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States