Assessing Inflammatory and Behavioral Pathways Linking PTSD to Increased Asthma Morbidity in WTC Workers
- Conditions
- PTSDAsthma
- Interventions
- Behavioral: Cognitive Processing TherapyBehavioral: PsychotherapyBehavioral: General Asthma EducationBehavioral: Targeted Asthma Education
- Registration Number
- NCT04552301
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Diagnosed with PTSD based on SCID or PCL-5
- Poorly controlled asthma based on ACQ score ≥1.5
- Completion of observational study 12-month visit
- Active Suicidal Ideation
- Co-existence of COPD or other chronic respiratory illnesses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychotherapy and General Asthma Education General Asthma Education Control group - Psychotherapy and General Asthma Education Cognitive Processing Therapy and Targeted Asthma Education Cognitive Processing Therapy Intervention group - Cognitive Processing Therapy and Targeted Asthma Education Cognitive Processing Therapy and Targeted Asthma Education Targeted Asthma Education Intervention group - Cognitive Processing Therapy and Targeted Asthma Education Psychotherapy and General Asthma Education Psychotherapy Control group - Psychotherapy and General Asthma Education
- Primary Outcome Measures
Name Time Method PTSD Checklist for DSM-5 (PCL-5) Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months The PTSD Checklist for DSM-5 (PCL-5), is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Full range from 0-80, higher score indicates more symptoms.
- Secondary Outcome Measures
Name Time Method Asthma Control Questionnaire (ACQ) Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months The ACQ assess asthma beliefs about asthma control. The ACQ is a 7-item instrument, full scale from 0-6, higher score indicates more impairment.
Asthma Quality of Life Questionnaire (AQLQ) Baseline, 1 week post-intervention, 3 months post-intervention The AQLQ assess asthma beliefs about asthma quality of life. The AQLQ is a 32-item instrument, full scale from 1-7, higher score indicates better health outcomes
Medication Adherence Report Scale (MARS) Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months The MARS assess asthma beliefs about asthma medication adherence. The MARS is a 10-item instrument, full range from 0-10, higher score indicates higher likelihood of medication adherence.
Illness Perception Questionnaire (IPQ) Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months The IPQ assess asthma beliefs about illness perception. The IPQ is an 80-item instrument, total scale from 0-80, with higher score indicating higher perception of effects on illness.
Beliefs About Medicines Questionnaire (BMQ) Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months Beliefs About Medicines Questionnaire (BMQ), a 10-item validated tool assessing medication necessity and concerns. The BMQ consists of two five-item scales assessing patients' beliefs about the necessity of medication and their concerns about taking it. Each item scored on a five-point Likert scale, ranging from 1 = strongly disagree to 5 = strongly agree. Total subscale scores for the Necessity and Concerns Scales range from 5 to 25. Higher scores indicate stronger beliefs.
Patient Health Questionnaire-9 (PHQ-9) Depression Severity Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Generalized Anxiety Disorder-7 Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Full scale from 0-21, with higher score indicating poorer health outcomes.
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States