N/A
N=38
Assessing Inflammatory and Behavioral Pathways Linking PTSD to Increased Asthma Morbidity in WTC Workers
Asthma · PTSD
Bottom Line
View on ClinicalTrials.gov: NCT04552301 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: PTSD Checklist for DSM-5 (PCL-5) — 39.2; 36.4; 32.9; 34.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Processing Therapy (Behavioral); Psychotherapy (Behavioral); Targeted Asthma Education (Behavioral); General Asthma Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Checklist for DSM-5 (PCL-5) |
39.2; 36.4; 32.9; 34.3; 29.8; 30.9 | — |
| SECONDARY Asthma Control Questionnaire (ACQ) |
2.1; 2.1; 1.7; 2.0; 1.9; 2.1 | — |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ) |
3.7; 3.7; 4.3; 3.9; 4.4; 3.8 | — |
| SECONDARY Medication Adherence Report Scale (MARS) |
4.4; 4.5; 4.5; 4.5; 4.6; 4.5 | — |
| SECONDARY Illness Perception Questionnaire (IPQ) |
47.0; 46.8; 41.4; 44.0; 42.7; 44.6 | — |
| SECONDARY Beliefs About Medicines Questionnaire (BMQ) |
20.1; 19.5; 20.7; 19.4; 19.5; 18.8 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) Depression Severity |
12.9; 10.9; 9.7; 10.4; 10.1; 9.7 | — |
| SECONDARY Generalized Anxiety Disorder-7 |
11.1; 9.4; 10.1; 8.9; 9.3; 8.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Pilot inclusion criteria:
- Diagnosed with PTSD based on SCID or PCL-5
- Poorly controlled asthma based on ACQ score ≥1.5; and
- Completion of observational study 12-month visit.
Exclusion Criteria
- Active Suicidal Ideation
- Co-existence of COPD or other chronic respiratory illnesses
Data sourced from ClinicalTrials.gov (NCT04552301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.