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

NCT ID: NCT02723097

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2017-10-11

Brief Summary

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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.

Detailed Description

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Conditions

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Post Traumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Relaxation Response Resiliency Program (3RP)

Group Type EXPERIMENTAL

3 RP

Intervention Type BEHAVIORAL

Interventions

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3 RP

Intervention Type BEHAVIORAL

Other Intervention Names

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Relaxation Response Resiliency Program

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucia Ferri, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-00721

Identifier Type: -

Identifier Source: org_study_id