A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02723097|
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder (PTSD)||Behavioral: 3 RP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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)|
|Actual Study Start Date :||March 1, 2016|
|Actual Primary Completion Date :||October 11, 2017|
|Actual Study Completion Date :||October 11, 2017|
|Experimental: Relaxation Response Resiliency Program (3RP)||
Behavioral: 3 RP
Other Name: Relaxation Response Resiliency Program
- Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV [ Time Frame: 1 Month ]State-of-the-art instrument for obtaining psychiatric diagnoses.
- Symptom Severity using PTSD Checklist [ Time Frame: 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.
- Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: 1 Month ]
- Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT) [ Time Frame: 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.
- Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS) [ Time Frame: 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.
- Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II) [ Time Frame: 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
- Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire. [ Time Frame: 1 Month ]The 6-item Treatment Credibility/Expectancy Questionnaire (CEQ)84 will be used to examine treatment expectancy related to the 3RP.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723097
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Lucia Ferri, MD||New York University Medical School|