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

Post Traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723097
• Other study ID #: 15-00721
• Status: Completed
• Phase: N/A
• First received: March 24, 2016
• Last updated: October 16, 2017
• Start date: March 1, 2016
• Est. completion date: October 11, 2017

Study information

• Verified date: October 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 11, 2017
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 3 RP

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV	State-of-the-art instrument for obtaining psychiatric diagnoses.	1 Month
Primary	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
Primary	Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)		1 Month
Primary	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
Primary	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
Primary	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
Primary	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