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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02723097

Enrollment

Registered

2016-03-30

Start date

2016-03-01

Completion date

2017-10-11

Last updated

2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder (PTSD)

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.

Interventions

BEHAVIORAL3 RP

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV	1 Month	State-of-the-art instrument for obtaining psychiatric diagnoses.
Symptom Severity using PTSD Checklist	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.
Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)	1 Month	—
Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT)	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.
Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS)	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.
Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II)	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
Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire.	1 Month	The 6-item Treatment Credibility/Expectancy Questionnaire (CEQ)84 will be used to examine treatment expectancy related to the 3RP.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026