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CompletedNCT02723097Updated Oct 18, 2017

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

An interventional study of 3 RP in Post Traumatic Stress Disorder (PTSD), sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-18.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Post Traumatic Stress Disorder (PTSD)
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In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Relaxation Response Resiliency Program (3RP)

    Behavioral: 3 RP

Interventions

  • Behavioral3 RP

    Also known as: Relaxation Response Resiliency Program

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What researchers measure

Primary outcomes

  1. Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV

    State-of-the-art instrument for obtaining psychiatric diagnoses.

    Time frame: 1 Month

  2. 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.

    Time frame: 1 Month

  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)

    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

  5. 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.

    Time frame: 1 Month

  6. 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

    Time frame: 1 Month

  7. 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.

    Time frame: 1 Month

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Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02723097
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Mar 30, 2016
Start date
Mar 1, 2016
Primary completion
Oct 11, 2017
Completion
Oct 11, 2017
Last update
Oct 18, 2017

Study contacts

Lucia Ferri, MD
principal investigator · New York University Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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