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

• ClinicalTrials.gov Identifier: NCT04552301
• Recruitment Status: Recruiting
• First Posted: September 17, 2020
• Last Update Posted: September 17, 2020
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma; PTSD	Behavioral: Cognitive Processing Therapy; Behavioral: Psychotherapy; Behavioral: Targeted Asthma Education; Behavioral: General Asthma Education	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Eligibility will be determined based on Asthma Control Questionnaire (ACQ) score >1.5, indicating uncontrolled asthma and results of the Structured Clinical Interview for DSM-5 Disorders (SCID) and/or PCL-5 showing evidence of PTSD. Participants will be consented by trained research staff and randomized 1:1 (stratified by level of asthma control) into an intervention (combined asthma self-management and cognitive processing therapy for PTSD) or an active attention control arm (supportive psychotherapy plus asthma education) after completing their 12-month visit.
• Masking: Single (Outcomes Assessor)
• Masking Description: Research coordinators (RCs) are blinded to study randomization and treatment arm for each participant.
• Primary Purpose: Treatment
• Official Title: Evaluating the Effectiveness of an Integrated Intervention for WTC Workers With PTSD and Asthma
• Actual Study Start Date: August 17, 2020
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: August 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cognitive Processing Therapy and Targeted Asthma Education; Intervention group - Cognitive Processing Therapy and Targeted Asthma Education	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.; Other Name: CPT; Behavioral: Targeted Asthma Education; The manualized 10-session program of asthma self-management; Other Name: Asthma Education
Active Comparator: Psychotherapy and General Asthma Education; Control group - Psychotherapy and General Asthma Education	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: General Asthma Education; A 10-session program of similar time; Other Name: Asthma Education

Outcome Measures

Primary Outcome Measures :

1. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 24 Weeks ]
   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 :

1. Asthma Control Questionnaire (ACQ) [ Time Frame: 24 Weeks ]
   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.
2. Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 24 Weeks ]
   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
3. Medication Adherence Report Scale (MARS) [ Time Frame: 24 Weeks ]
   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.
4. Illness Perception Questionnaire (IPQ) [ Time Frame: 24 Weeks ]
   The IPQ assess asthma beliefs about illness perception. The IPQ is an 80-item instrument, total scale from 0-10, with higher score indicating higher perception of effects on illness.
5. Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: 24 Weeks ]
   The BMQ assess beliefs about medications. The BMQ has two components: beliefs about overuse (score range from 3-15) and perceived risk of medicines (score range from 5-25), total scale 8-40, higher score indicates stronger beliefs in the concepts of the scale.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Active Suicidal Ideation
• Co-existence of COPD or other chronic respiratory illnesses

Contacts and Locations

Contacts

Contact: Shynah James, MPH; 212-824-7983; shynah.james@mountsinai.org

Locations

United States, New York

Icahn School of Medicine at Mount Sinai; Recruiting

New York, New York, United States, 10029

Principal Investigator: Juan P Wisnivesky, MD, DrPH

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Juan P Wisnivesky, MD, DrPH; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Juan P Wisnivesky, Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT04552301
• Other Study ID Numbers: GCO 16-0945
• First Posted: September 17, 2020
• Last Update Posted: September 17, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai:

World Trade Center; Cognitive Processing Therapy; Asthma; Intervention; Pilot Randomized Control Trial

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases