Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04552301 |
| Other study ID # |
GCO 16-0945 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 17, 2020 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Icahn School of Medicine at Mount Sinai |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Significance: Importance of the Problem: Multiple studies have shown a high prevalence of
asthma in WTC rescue and recovery workers, local residents, and passersby. Using data from
the National Health Interview Survey (NHIS), the study team found that WTC workers have twice
the risk of asthma compared to the general United States (US) population. Data from the WTCHP
shows a 28% cumulative incidence of asthma 9 years after September 11, 2001 among WTC
workers. These studies show that asthma is the most prevalent respiratory condition among WTC
rescue and recovery workers.
WTC workers with asthma include individuals with prior history of the disease and new cases
of irritant-induced asthma. Many workers with preexistent asthma developed worsening symptoms
after WTC-related exposures (WTC-exacerbated asthma). Other workers developed new asthma
symptoms without latency during or after WTC exposure and were diagnosed with
irritant-induced asthma. Multiple cases of new onset asthma among WTC workers have been
reported in the years following exposure to the WTC site; characterization of these cases has
been more difficult. Despite this potential heterogeneity, these conditions are frequently
grouped in clinical practice as WTC-related asthma and managed similarly.
Studies found substantial burden of asthma morbidity in WTC workers and exposed community
members, with reports of poorly-controlled in 34% and very poorly-controlled symptoms in 35%
of exposed individuals. Increased risk of emergency department (ED) visits and
hospitalizations as well as poor quality of life in WTC workers with asthma have been
reported, showing a major impact on health.
Scientific Premise of Project: PTSD is Associated with Increased Asthma Morbidity in WTC
Workers: Prevalence of psychological symptoms in WTC-exposed populations is high; with PTSD
reported as the most common (~30%) mental health condition. Studies have also found high
rates (25-35%) of PTSD comorbidity in WTC workers with asthma. Mental health conditions and
PTSD in particular, have been associated with increased asthma morbidity. The study team
found that WTC workers with PTSD had worse asthma control, increased healthcare use, and
poorer quality of life.
. Similarly, a study of WTC workers indicated that severity of PTSD symptoms predicted new
onset and worsening of asthma. Data from studies in the general population have also shown
that PTSD is associated with higher asthma morbidity. In summary, studies have documented a
high level of overlap between asthma and PTSD in WTC workers and other exposed populations
and have documented that PTSD is a major contributor to increased asthma morbidity. However,
the underlying mechanisms explaining this relationship remain unknown.
PTSD May Negatively Impact Asthma SMB: Asthma self-management encompasses several complex
behaviors such as adherence to controller medications, adequate inhaler technique, use of
action plans, allergen avoidance, and avoiding tobacco exposure that are critical for
adequate disease control. Adherence to controller medications in particular, is a factor that
heavily influences the outcomes of asthmatics. Studies conducted in the general population
and the preliminary data from WTC workers shown that only ~50% of patients with asthma adhere
to controller therapy or other SMB.
Mental health conditions are associated with low adherence to chronic disease SMB. PTSD, in
particular, has been strongly associated with low treatment adherence in multiple chronic
diseases. With smoking being an important part of asthma self-management, it is of special
concern that higher rates of smoking have been reported among WTC workers with PTSD. Thus,
low adherence to SMB may mediate, in part, the association between PTSD and increased asthma
morbidity. However, there is limited data regarding the relationship between PTSD and asthma
SMB in the general population or among WTC workers, in particular.
Despite the strong link between asthma and PTSD in WTC workers, there are no interventions
aimed at managing both conditions. During the observational component of the study, the
researchers found evidence that PTSD was linked to worse asthma morbidity and WTC workers
with PTSD did not have increased perception of symptoms. As part of this study, the
researchers will test an integrated strategy using Cognitive Processing Therapy (CPT) and
asthma self-management support to improve the outcomes of WTC workers with PTSD and asthma.
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 self-management support component will be based on material the
researchers developed as part of the SAMBA trial for elderly patients with asthma.
