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

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ClinicalTrials.gov Identifier: NCT02723097
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder (PTSD) Behavioral: 3 RP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Relaxation Response Resiliency Program (3RP) Behavioral: 3 RP
Other Name: Relaxation Response Resiliency Program


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: 1 Month ]
  4. 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.

  5. 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.

  6. 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

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Lucia Ferri, MD New York University Medical School
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02723097    
Other Study ID Numbers: 15-00721
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders