{"protocolSection":{"identificationModule":{"nctId":"NCT02813447","orgStudyIdInfo":{"id":"Pro00071349"},"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)","officialTitle":"Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease","acronym":"SAD-COPD"},"statusModule":{"statusVerifiedDate":"2021-09","overallStatus":"TERMINATED","whyStopped":"COVID-19 hold","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-08","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-02-20","type":"ACTUAL"},"completionDateStruct":{"date":"2019-02-20","type":"ACTUAL"},"studyFirstSubmitDate":"2016-06-13","studyFirstSubmitQcDate":"2016-06-22","studyFirstPostDateStruct":{"date":"2016-06-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2022-07-29","resultsFirstSubmitQcDate":"2025-06-26","resultsFirstPostDateStruct":{"date":"2025-07-01","type":"ACTUAL"},"dispFirstSubmitDate":"2021-09-01","dispFirstSubmitQcDate":"2021-09-01","dispFirstPostDateStruct":{"date":"2021-09-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-06-26","lastUpdatePostDateStruct":{"date":"2025-07-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Duke University","class":"OTHER"}},"descriptionModule":{"briefSummary":"Objective: Determine whether treatment of perceived stress, anxiety, and depression with anti-depressant therapy improves dyspnea scores, 6-minute walk (6MW) distance and quality of life (QoL) in patients with Chronic Obstructive Pulmonary Disease (COPD) and ILD (Interstitial Lung Disease) undergoing pulmonary rehab.\n\nThe study is a prospective, randomized, double-blinded, placebo-controlled study to assess the effect of an SSRI on 6MW, dyspnea scores, and QoL in COPD and ILD patients undergoing pulmonary rehab. Thirty subjects that carry an ICD-9 code diagnosis of COPD and/or ILD and CES-D (Center for Epidemiologic Studies Depression) score of \\> 16 will be recruited from Duke Pulmonary Rehab.\n\nMultivariable regression models will be constructed to evaluate the relationship between perceived stress, anxiety, and depression with adjustments by race, gender, age, BMI and GOLD score. A multivariable regression model will be constructed to assess whether treatment of perceived stress, depression, and anxiety with antidepressant therapy (sertraline) is an effect modifier on 6MW distance and dyspnea scores in patients with COPD or ILD who are enrolled in pulmonary rehab.\n\nDescriptive statistics will be used to examine the socio-demographic characteristic data. Student t-tests will be performed to assess group differences in continuous data. Categorical variables will be examined using the Pearson's Chi-Squared test."},"conditionsModule":{"conditions":["COPD","Anxiety","Depression","Stress","Interstitial Lung Disease"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":13,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Pulmonary Rehab + Study Drug","type":"ACTIVE_COMPARATOR","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.","interventionNames":["Drug: Sertraline"]},{"label":"Pulmonary Rehab + Placebo","type":"PLACEBO_COMPARATOR","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Sertraline","armGroupLabels":["Pulmonary Rehab + Study Drug"]},{"type":"DRUG","name":"Placebo","armGroupLabels":["Pulmonary Rehab + Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in 6MW Distance","description":"Patients will undergo 6-minute walk at visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12)."},{"measure":"Change in Dyspnea Scores, as Measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)","description":"To monitor changes in dyspnea scores, patients will complete the UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB). Participants will complete this at all visits (1-6). The UCSD is a 24-item questionnaire that asks participants to rate themselves from 0 (\"Not at all\") to 5 (\"Maximally or unable to do because of breathlessness\"). Scores range from 0-120, with higher scores indicating greater dyspnea.","timeFrame":"visit 1(baseline), visit 4 (week 4), visit 6 (week 12)"}],"secondaryOutcomes":[{"measure":"Change in Quality of Life, as Measured by Ferrans & Powers Quality of Life Index - Pulmonary Version (QOL)","description":"To monitor changes in quality of life, patients will complete the Ferrans \\& Powers Quality of Life Index - Pulmonary version (QOL). Scores range from 0 to 30, with higher scores indicating a higher quality of life.","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12)."},{"measure":"Change in Perceived Stress, as Measured by General Health Questionnaire-12 (GHQ-12)","description":"To monitor changes in perceived stress, patients will complete the General Health Questionnaire-12 (GHQ-12). Scores range from 0 to 36, with higher scores indicating greater distress.","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12)."},{"measure":"Change in Anxiety, as Measured by Hamilton Anxiety and Depression Scale (HADS)","description":"Scores on the HADS range from 0-21, with higher scores indicating more severe of symptoms.","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12)."},{"measure":"Change in Anxiety, as Measured by the Anxiety Inventory for Respiratory Disease (AIR) Questionnaire","description":"Scores on the Anxiety Inventory for Respiratory Disease (AIR) range from 0-30, with higher scores indicating more symptoms.","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12)."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female with an ICD-9 code diagnosis of COPD and/or ILD\n* Mild, moderate, or severe major depression symptoms based on Center of Epidemiologic Studies Depression (CES-D) score \\> 16.\n* Able to complete informed consent†\n* Read and write in English\n\nExclusion Criteria:\n\n* Current treatment with antidepressants\n* Current treatment with anti-psychotics\n* Severe physical disability that would interfere with lung assessment\n* History of major psychiatric illness, including bipolar disorder, psychoses, and/or severe personality disorder.\n* Active suicidal ideations\n* Serious cognitive problems (dementia syndrome) or cognitive impairment defined as MMSE \\< 22\n* Recent loss of spouse within 6 weeks of study enrollment.\n* History of alcohol or drug dependence in the last 6 months.\n* Pregnant women or nursing mothers\n* Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator.","healthyVolunteers":false,"sex":"ALL","minimumAge":"40 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Anne Mathews, MD","affiliation":"Duke University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Duke Pulmonary Rehabilitation","city":"Durham","state":"North Carolina","zip":"27705","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline"},{"id":"FG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline"},{"id":"BG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"13"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"8"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"13"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"13"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in 6MW Distance","description":"Patients will undergo 6-minute walk at visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).","populationDescription":"only participants who completed all 3 visits (visits 1, 4, and 6) were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"feet","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).","groups":[{"id":"OG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline"},{"id":"OG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"}]}],"classes":[{"title":"change from baseline to Visit 4","categories":[{"measurements":[{"groupId":"OG000","value":"-264.00","spread":"0"},{"groupId":"OG001","value":"273.20","spread":"103.89"}]}]},{"title":"change from baseline to Visit 6","categories":[{"measurements":[{"groupId":"OG000","value":"-94.00","spread":"0"},{"groupId":"OG001","value":"163.60","spread":"312.50"}]}]}]},{"type":"PRIMARY","title":"Change in Dyspnea Scores, as Measured by UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB)","description":"To monitor changes in dyspnea scores, patients will complete the UCSD Medical Center Pulmonary Rehabilitation Program Shortness of Breath Questionnaire (UCSD-SOB). Participants will complete this at all visits (1-6). The UCSD is a 24-item questionnaire that asks participants to rate themselves from 0 (\"Not at all\") to 5 (\"Maximally or unable to do because of breathlessness\"). Scores range from 0-120, with higher scores indicating greater dyspnea.","populationDescription":"Participants with data at the indicated time points are included in the analysis. All collected data are reported.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"visit 1(baseline), visit 4 (week 4), visit 6 (week 12)","groups":[{"id":"OG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline"},{"id":"OG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"62.67","spread":"8.08"},{"groupId":"OG001","value":"36.00","spread":"14.33"}]}]},{"title":"Change from Baseline to Visit 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-0.50","spread":"6.36"},{"groupId":"OG001","value":"7.50","spread":"26.16"}]}]},{"title":"Change from Baseline to Visit 6","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.00","spread":"0.00"},{"groupId":"OG001","value":"-14.00","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Change in Quality of Life, as Measured by Ferrans & Powers Quality of Life Index - Pulmonary Version (QOL)","description":"To monitor changes in quality of life, patients will complete the Ferrans \\& Powers Quality of Life Index - Pulmonary version (QOL). Scores range from 0 to 30, with higher scores indicating a higher quality of life.","populationDescription":"Participants with data at the indicated time points are included in the analysis. All collected data are reported.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).","groups":[{"id":"OG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline"},{"id":"OG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"19.23","spread":"5.26"},{"groupId":"OG001","value":"20.12","spread":"2.77"}]}]},{"title":"Change from Baseline to Visit 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"4.53","spread":"0.00"},{"groupId":"OG001","value":"-0.40","spread":"0.00"}]}]},{"title":"Change from Baseline to Visit 6","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in Perceived Stress, as Measured by General Health Questionnaire-12 (GHQ-12)","description":"To monitor changes in perceived stress, patients will complete the General Health Questionnaire-12 (GHQ-12). Scores range from 0 to 36, with higher scores indicating greater distress.","populationDescription":"Participants with data at the indicated time points are included in the analysis. All collected data are reported.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).","groups":[{"id":"OG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline"},{"id":"OG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.33","spread":"6.51"},{"groupId":"OG001","value":"11.50","spread":"5.07"}]}]},{"title":"GHQ Change from Baseline to Visit 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-2.50","spread":"2.12"},{"groupId":"OG001","value":"-3.67","spread":"3.79"}]}]},{"title":"GHQ Change from Baseline to Visit 6","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"-7.00","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Change in Anxiety, as Measured by Hamilton Anxiety and Depression Scale (HADS)","description":"Scores on the HADS range from 0-21, with higher scores indicating more severe of symptoms.","populationDescription":"Participants with data at the indicated time points are included in the analysis. All collected data are reported.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).","groups":[{"id":"OG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline"},{"id":"OG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"16.67","spread":"6.11"},{"groupId":"OG001","value":"11.00","spread":"6.98"}]}]},{"title":"Change from Baseline to Visit 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-6.50","spread":"3.54"},{"groupId":"OG001","value":"-0.67","spread":"2.08"}]}]},{"title":"Change from Baseline to Visit 6","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-3.00","spread":"0.00"},{"groupId":"OG001","value":"-7.00","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Change in Anxiety, as Measured by the Anxiety Inventory for Respiratory Disease (AIR) Questionnaire","description":"Scores on the Anxiety Inventory for Respiratory Disease (AIR) range from 0-30, with higher scores indicating more symptoms.","populationDescription":"Participants with data at the indicated time points are included in the analysis. All collected data are reported.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"visit 1(baseline), visit 4 (after one month of study drug + intensive pulmonary rehab), and visit 6 (week 12).","groups":[{"id":"OG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline"},{"id":"OG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"categories":[{"measurements":[{"groupId":"OG001","value":"15.00","spread":"0.00"}]}]},{"title":"Visit 4","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Visit 6","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"12 weeks","eventGroups":[{"id":"EG000","title":"Pulmonary Rehab + Study Drug","description":"Subjects randomized into this arm will be given active study drug (sertraline). Subjects will take 25mg tablets by mouth daily starting at visit 1 along with participating in the intensive pulmonary rehab program. Subjects will be assessed at one week intervals +/- 7 days for tolerability and side effects, and if tolerating study drug, the dose will be increased weekly by 25mg over the course of the first four weeks with maximum effective dose of 100mg daily by the end of week four. Subjects will continue this dose over the course of the remaining 8 weeks of the study, while participating in the graduate program of pulmonary rehab.\n\nSertraline","deathsNumAffected":1,"deathsNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"otherNumAffected":2,"otherNumAtRisk":6},{"id":"EG001","title":"Pulmonary Rehab + Placebo","description":"Subjects randomized to the placebo arm will have the same procedures as described above in the study drug arm with the exception that they will be receiving matched placebo drug.\n\nPlacebo","deathsNumAffected":0,"deathsNumAtRisk":7,"seriousNumAffected":0,"seriousNumAtRisk":7,"otherNumAffected":0,"otherNumAtRisk":7}],"seriousEvents":[{"term":"dyspnea","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":7}]}],"otherEvents":[{"term":"nausea, vomiting and jitteriness","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":7}]},{"term":"drowsiness, lethargy and jitteriness","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6},{"groupId":"EG001","numAffected":0,"numAtRisk":7}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"The data captured was deemed unreliable due to the turnover among study personnel and insufficient personnel to administer the questionnaires accurately."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Neil MacIntyre","organization":"Duke University Medical Center","email":"macin001@mc.duke.edu","phone":"919 681 2720"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2022-07-26","uploadDate":"2022-07-29T14:49","filename":"Prot_SAP_000.pdf","size":519334}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D029424","term":"Pulmonary Disease, Chronic Obstructive"},{"id":"D001008","term":"Anxiety Disorders"},{"id":"D003863","term":"Depression"},{"id":"D017563","term":"Lung Diseases, Interstitial"}],"ancestors":[{"id":"D008173","term":"Lung Diseases, Obstructive"},{"id":"D008171","term":"Lung Diseases"},{"id":"D012140","term":"Respiratory Tract Diseases"},{"id":"D002908","term":"Chronic Disease"},{"id":"D020969","term":"Disease Attributes"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D001523","term":"Mental Disorders"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D020280","term":"Sertraline"}],"ancestors":[{"id":"D015057","term":"1-Naphthylamine"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009281","term":"Naphthalenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}