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

NCT02723097 | Completed

• 1 other identifier: 15-00721
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Relaxation Response Resiliency Program (3RP)

EXPERIMENTAL

Behavioral: 3 RP

Interventions

3 RP BEHAVIORAL

Also known as: Relaxation Response Resiliency Program

Relaxation Response Resiliency Program (3RP)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Lucia Ferri, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: October 11, 2017
• Study Completion: October 11, 2017
• Last Updated: October 18, 2017

Record last verified: 2017-10

Locations

US (1)