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Completed

NCT Number: NCT02723097

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

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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Key information

Conditions

Post Traumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3 RP

Behavioral

Other names: Relaxation Response Resiliency Program

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2016
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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