Back to resultsA Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
Primary Purpose
Post Traumatic Stress Disorder (PTSD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3 RP
Sponsored by
About this trial
This is an interventional supportive care trial for Post Traumatic Stress Disorder (PTSD)
Eligibility 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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Relaxation Response Resiliency Program (3RP)
Arm Description
Outcomes
Primary Outcome Measures
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV
State-of-the-art instrument for obtaining psychiatric diagnoses.
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.
Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)
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.
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.
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02723097
Brief Title
A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
October 11, 2017 (Actual)
Study Completion Date
October 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder (PTSD)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relaxation Response Resiliency Program (3RP)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
3 RP
Other Intervention Name(s)
Relaxation Response Resiliency Program
Primary Outcome Measure Information:
Title
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV
Description
State-of-the-art instrument for obtaining psychiatric diagnoses.
Time Frame
1 Month
Title
Symptom Severity using PTSD Checklist
Description
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.
Time Frame
1 Month
Title
Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)
Time Frame
1 Month
Title
Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT)
Description
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.
Time Frame
1 Month
Title
Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS)
Description
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.
Time Frame
1 Month
Title
Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II)
Description
he HPLP-II is a 52 item self-report inventory of health behaviors and has been used in previous mind-body treatment studies
Time Frame
1 Month
Title
Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire.
Description
The 6-item Treatment Credibility/Expectancy Questionnaire (CEQ)84 will be used to examine treatment expectancy related to the 3RP.
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia Ferri, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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