Assessing Inflammatory and Behavioral Pathways Linking PTSD to Increased Asthma Morbidity in WTC Workers

NCT04552301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2024-09-19

Study results available
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Summary

Asthma and post-traumatic stress disorder (PTSD) are the most common conditions in World Trade Center (WTC) rescue and recovery workers. In this study, the study team will evaluate the interplay of biological and behavioral mechanisms explaining the relationship of PTSD with increase asthma morbidity and adapt and pilot test a novel intervention to improve outcomes of WTC workers.

Conditions

Interventions

BEHAVIORAL

Cognitive Processing Therapy

Integrated CPT. CPT is based on a social cognitive theory of PTSD that focuses on how the traumatic event is construed and coped with by a person who is trying to regain a sense of mastery and control in his or her life. The asthma components that will be integrated into the intervention include psychoeducation about asthma, barriers to asthma self-care, asthma medication education, inhaler technique, and asthma self-management behaviors.

BEHAVIORAL

Psychotherapy

The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.

BEHAVIORAL

Targeted Asthma Education

The manualized 10-session program of asthma self-management

BEHAVIORAL

General Asthma Education

A 10-session program of similar time

Sponsors & Collaborators

Principal Investigators

  • Juan P Wisnivesky, MD, DrPH · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552301 on ClinicalTrials.gov