Trial Outcomes & Findings for Assessing Inflammatory and Behavioral Pathways Linking PTSD to Increased Asthma Morbidity in WTC Workers (NCT NCT04552301)
NCT ID: NCT04552301
Last Updated: 2024-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
361 participants
Primary outcome timeframe
Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 months
Results posted on
2024-09-19
Participant Flow
10 participants did not have their baseline demographic info because they were added later on in the pilot study
Participant milestones
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Inflammatory and Behavioral Pathways Linking PTSD to Increased Asthma Morbidity in WTC Workers
Baseline characteristics by cohort
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=12 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=16 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported or Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education
8th grade or less
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
Some high school
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
High school or GED
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
1 to 3 years of college
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Education
4-year college graduate
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Higher degree
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Missing information
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Monthly income
Less than $3000
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Monthly income
More than $3000
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Monthly income
Missing Information
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital status
Unmarried
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Marital status
Married
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Language
Mostly English
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Language
Mostly Spanish
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Language
About the same
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Smoking status
Current/former smoker
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Smoking status
Never smoker
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Smoking status
Missing Information
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Insurance
Medicare
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Insurance
Medicaid
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Insurance
Medicare and Medicaid
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Insurance
Private
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Insurance
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Insurance
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 monthsPopulation: Data available for participants who completed instrument.
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.
Outcome measures
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=19 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=19 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Pilot Baseline Pre-Intervention
|
39.2 score on a scale
Standard Deviation 10.3
|
36.4 score on a scale
Standard Deviation 9.6
|
|
PTSD Checklist for DSM-5 (PCL-5)
1 Week Post-Intervention
|
32.9 score on a scale
Standard Deviation 14.7
|
34.3 score on a scale
Standard Deviation 11.3
|
|
PTSD Checklist for DSM-5 (PCL-5)
3 Months Post-Intervention
|
29.8 score on a scale
Standard Deviation 17.4
|
30.9 score on a scale
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 monthsPopulation: Data available for participants who completed instrument.
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.
Outcome measures
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=19 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=19 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ)
Pilot Baseline Pre-Intervention
|
2.1 score on a scale
Standard Deviation 1.1
|
2.1 score on a scale
Standard Deviation 0.4
|
|
Asthma Control Questionnaire (ACQ)
1 Week Post-Intervention
|
1.7 score on a scale
Standard Deviation 1.0
|
2.0 score on a scale
Standard Deviation 2.1
|
|
Asthma Control Questionnaire (ACQ)
3 Months Post-Intervention
|
1.9 score on a scale
Standard Deviation 1.5
|
2.1 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, 1 week post-intervention, 3 months post-interventionPopulation: Data available for participants who completed instrument.
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
Outcome measures
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=19 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=19 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ)
Pilot Baseline Pre-Intervention
|
3.7 score on a scale
Standard Deviation 1.1
|
3.7 score on a scale
Standard Deviation 0.8
|
|
Asthma Quality of Life Questionnaire (AQLQ)
1 Week Post-Intervention
|
4.3 score on a scale
Standard Deviation 1.2
|
3.9 score on a scale
Standard Deviation 1.0
|
|
Asthma Quality of Life Questionnaire (AQLQ)
3 Months Post-Intervention
|
4.4 score on a scale
Standard Deviation 1.6
|
3.8 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 monthsPopulation: Data available for participants who completed instrument.
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.
Outcome measures
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=19 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=19 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
Medication Adherence Report Scale (MARS)
Pilot Baseline Pre-Intervention
|
4.4 score on a scale
Standard Deviation 0.8
|
4.5 score on a scale
Standard Deviation 0.7
|
|
Medication Adherence Report Scale (MARS)
1 Week Post-Intervention
|
4.5 score on a scale
Standard Deviation 0.6
|
4.5 score on a scale
Standard Deviation 1.1
|
|
Medication Adherence Report Scale (MARS)
3 Months Post-Intervention
|
4.6 score on a scale
Standard Deviation 0.6
|
4.5 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 monthsPopulation: Data available for participants who completed instrument.
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.
Outcome measures
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=19 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=19 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
Illness Perception Questionnaire (IPQ)
Pilot Baseline Pre-Intervention
|
47.0 score on a scale
Standard Deviation 14.3
|
46.8 score on a scale
Standard Deviation 12.3
|
|
Illness Perception Questionnaire (IPQ)
1 Week Post-Intervention
|
41.4 score on a scale
Standard Deviation 10.3
|
44.0 score on a scale
Standard Deviation 12.3
|
|
Illness Perception Questionnaire (IPQ)
3 Months Post-Intervention
|
42.7 score on a scale
Standard Deviation 13.1
|
44.6 score on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 monthsPopulation: Data available for participants who completed instrument.
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.
Outcome measures
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=19 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=19 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
Beliefs About Medicines Questionnaire (BMQ)
Pilot Baseline Pre-Intervention Concerns Score
|
16.3 score on a scale
Standard Deviation 2.7
|
17.2 score on a scale
Standard Deviation 4.0
|
|
Beliefs About Medicines Questionnaire (BMQ)
Pilot Baseline Pre-Intervention Necessity Score
|
20.1 score on a scale
Standard Deviation 2.8
|
19.5 score on a scale
Standard Deviation 3.2
|
|
Beliefs About Medicines Questionnaire (BMQ)
1 Week Post-Intervention Necessity Score
|
20.7 score on a scale
Standard Deviation 1.8
|
19.4 score on a scale
Standard Deviation 4.1
|
|
Beliefs About Medicines Questionnaire (BMQ)
3 Months Post-Intervention Necessity Score
|
19.5 score on a scale
Standard Deviation 3.5
|
18.8 score on a scale
Standard Deviation 3.7
|
|
Beliefs About Medicines Questionnaire (BMQ)
1 Week Post-Intervention Concerns Score
|
16.0 score on a scale
Standard Deviation 3.7
|
16.9 score on a scale
Standard Deviation 4.4
|
|
Beliefs About Medicines Questionnaire (BMQ)
3 Months Post-Intervention Concerns Score
|
17.1 score on a scale
Standard Deviation 4.6
|
16.0 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 monthsPopulation: Data available for participants who completed instrument.
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.
Outcome measures
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=19 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=19 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9) Depression Severity
Pilot Baseline Pre-Intervention
|
12.9 score on a scale
Standard Deviation 5.4
|
10.9 score on a scale
Standard Deviation 4.9
|
|
Patient Health Questionnaire-9 (PHQ-9) Depression Severity
1 Week Post-Intervention
|
9.7 score on a scale
Standard Deviation 4.6
|
10.4 score on a scale
Standard Deviation 6.4
|
|
Patient Health Questionnaire-9 (PHQ-9) Depression Severity
3 Months Post-Intervention
|
10.1 score on a scale
Standard Deviation 7.5
|
9.7 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline; 1 week post-intervention, up to 11 weeks; 3 months post-intervention, up to 5.5 monthsPopulation: Data available for participants who completed instrument.
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.
Outcome measures
| Measure |
Cognitive Processing Therapy and Targeted Asthma Education
n=19 Participants
Intervention group - Cognitive Processing Therapy and Targeted Asthma Education
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.
Targeted Asthma Education: The manualized 10-session program of asthma self-management
|
Psychotherapy and General Asthma Education
n=19 Participants
Psychotherapy and General Asthma Education
Psychotherapy: The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
General Asthma Education: A 10-session program of similar time
|
|---|---|---|
|
Generalized Anxiety Disorder-7
Pilot Baseline Pre-Intervention
|
11.1 score on a scale
Standard Deviation 5.1
|
9.4 score on a scale
Standard Deviation 4.6
|
|
Generalized Anxiety Disorder-7
1 Week Post-Intervention
|
10.1 score on a scale
Standard Deviation 5.6
|
8.9 score on a scale
Standard Deviation 5.7
|
|
Generalized Anxiety Disorder-7
3 Months Post-Intervention
|
9.3 score on a scale
Standard Deviation 7.8
|
8.1 score on a scale
Standard Deviation 5.2
|
Adverse Events
Cognitive Processing Therapy and Targeted Asthma Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Psychotherapy and General Asthma Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Juan Wisnivesky
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-2125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place