Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 1:39 AM
Study NCT ID:
NCT00644995
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2008-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of The Step Up Wellness Program for People With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcclure.j@ghc.org', 'phone': '206-287-2737', 'title': 'Jennifer McClure, PhD', 'organization': 'Group Health Cooperative'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This was a pilot feasibility trial and was not powered to detect statistically significant outcomes.\n\nPoint prevalent abstinence outcomes imputed missing values as smokers.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression, and physical activity', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care'}, {'id': 'OG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression and physical activity'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '1.85'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': '% with significant change (50% reduction in SCL \\[Symptom Checklist\\] depression score)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Abstinent From Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care'}, {'id': 'OG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression and PA'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'self-reported 7 day point prevalent abstinence with non-responders coded as smokers', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Days Walk Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care'}, {'id': 'OG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression, and PA'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '7.0'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean change in days walk per week from baseline', 'unitOfMeasure': 'mean change in days walked per week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Minutes Per Week of Moderate Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care'}, {'id': 'OG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression, and PA'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '-360', 'upperLimit': '1500'}, {'value': '121', 'groupId': 'OG001', 'lowerLimit': '-600', 'upperLimit': '2520'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)', 'unitOfMeasure': 'mean change in minutes per week of PA', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Minutes Per Week of Vigorous Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care'}, {'id': 'OG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression, and PA'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '-45.0', 'upperLimit': '360.0'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-960.0', 'upperLimit': '480.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean change from baseline assessed using IPAQ physical activity scale', 'unitOfMeasure': 'minutes per week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care'}, {'id': 'OG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression, and PA'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-14.0', 'upperLimit': '10.0'}, {'value': '-3.2', 'groupId': 'OG001', 'lowerLimit': '-20.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 months', 'description': 'Mean change in cigarettes smoked per day from baseline', 'unitOfMeasure': 'mean change in number of cigs/day smoked', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quit Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care'}, {'id': 'OG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression, and PA'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': '% who made a quit attempt, defined as intentionally not smoking for at least 24 hours', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Advice to quit and referral to standard care'}, {'id': 'FG001', 'title': 'Step Up', 'description': 'proactive phone counseling addressing smoking, depression, and PA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Completed 4 Month Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 6 month assessment', 'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Refused', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from Group Health, a large regional health plan.Potential participants were identified from automated medical records, mailed study invitation letters, and then contacted by phone to be screened for interest and eligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Advice to quit smoking and referral to standard care'}, {'id': 'BG001', 'title': 'Step Up', 'description': 'Proactive phone counseling addressing smoking, depression, and physical activity (PA)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '43.5', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '44.5', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2008-03-25', 'resultsFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-23', 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Score', 'timeFrame': '6 months', 'description': '% with significant change (50% reduction in SCL \\[Symptom Checklist\\] depression score)'}, {'measure': 'Abstinent From Smoking', 'timeFrame': '6 months', 'description': 'self-reported 7 day point prevalent abstinence with non-responders coded as smokers'}, {'measure': 'Days Walk Per Week', 'timeFrame': '6 months', 'description': 'Mean change in days walk per week from baseline'}, {'measure': 'Minutes Per Week of Moderate Physical Activity', 'timeFrame': '6 months', 'description': 'Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)'}, {'measure': 'Minutes Per Week of Vigorous Physical Activity', 'timeFrame': '6 months', 'description': 'Mean change from baseline assessed using IPAQ physical activity scale'}], 'secondaryOutcomes': [{'measure': 'Number of Cigarettes Smoked Per Day', 'timeFrame': '4 months', 'description': 'Mean change in cigarettes smoked per day from baseline'}, {'measure': 'Quit Attempt', 'timeFrame': '6 months', 'description': '% who made a quit attempt, defined as intentionally not smoking for at least 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Smoking', 'Physical Activity'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '21414216', 'type': 'RESULT', 'citation': 'McClure JB, Catz SL, Ludman EJ, Richards J, Riggs K, Grothaus L. Feasibility and acceptability of a multiple risk factor intervention: the Step Up randomized pilot trial. BMC Public Health. 2011 Mar 17;11:167. doi: 10.1186/1471-2458-11-167.'}]}, 'descriptionModule': {'briefSummary': 'This randomized pilot study will evaluate the feasibility and acceptability of a phone-based wellness program for improving mood, physical activity, and smoking abstinence rates among people with depression who also are physically inactive and smoke cigarettes.', 'detailedDescription': 'This pilot study will evaluate the feasibility, acceptability, and potential effectiveness of the Step Up Wellness Program among people with depression who also are physically inactive and smoke cigarettes.\n\nParticipation in this study will last 6 months. All participants will complete a baseline survey and then be assigned randomly to receive the Step Up Wellness Program or usual care for 3 months. Participants in the Step Up program will receive weekly phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking. Participants will also be given materials to review and homework assignments between calls. Participants in the usual care group will receive standard care which includes referrals for treatment of depression and nicotine dependence, as well as self-help information on physical activity. All participants will be surveyed at 4 and 6 months post-enrollment. Participants will also provide qualitative feedback on the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Member of Group Health insurance plan\n* Aged 18 to 75\n* Experiencing at least moderate depressive symptoms\n* Low physical activity defined as failure to meet Centers for Disease Control (CDC) guidelines for weekly activity OR low to moderate physical activity as assessed by International Physical Activity Questionnaire (IPAQ)\n* Current smoker\n* Has a phone\n* Able to read and speak in English\n* No mobility or physical impairments that would prevent engaging in moderate physical activity\n* Without a hearing impairment that would prevent participation with the phone-based counseling or assessments\n\nExclusion Criteria:\n\n* Self-report of bipolar disorder or schizophrenia\n* Currently receiving specialty mental health care or smoking cessation treatment\n* If on an antidepressant, has been taking it less than 30 days'}, 'identificationModule': {'nctId': 'NCT00644995', 'briefTitle': 'Effectiveness of The Step Up Wellness Program for People With Depression', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Step Up Wellness Program for Depression, Physical Inactivity, and Smoking', 'orgStudyIdInfo': {'id': 'R34MH080658', 'link': 'https://reporter.nih.gov/quickSearch/R34MH080658', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R34MH080658', 'link': 'https://reporter.nih.gov/quickSearch/R34MH080658', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Control', 'description': "Participants will receive usual care which includes advice to stop smoking and referral to standard care treatment available through participants' health insurance and health plan.", 'interventionNames': ['Behavioral: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Step Up Intervention', 'description': 'Participants will receive the Step Up Wellness Program. The intervention is detailed below.', 'interventionNames': ['Behavioral: Step Up Wellness Program']}], 'interventions': [{'name': 'Step Up Wellness Program', 'type': 'BEHAVIORAL', 'description': 'Participants in the Step Up Wellness program will receive weekly phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking.', 'armGroupLabels': ['Step Up Intervention']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.', 'armGroupLabels': ['Usual Care Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Group Health Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jennifer McClure, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Group Heatlh Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}