Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-31 @ 8:00 AM
Study NCT ID:
NCT01624168
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'caldwellkaren@appstate.edu', 'phone': '828-262-6045', 'title': 'Dr. Karen Caldwell, Professor', 'organization': 'Appalachian State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'None of the reported Serious Adverse Events or Adverse Events were determined to be a result of participation in the intervention.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Participants were asked to complete weekly reports of mood using the Generalized Anxiety Disorder-7 scale and the Patient Health Questionnaire - 2. Participants also were asked about adverse events at 4-week and 10-week laboratory visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study', 'otherNumAtRisk': 19, 'otherNumAffected': 9, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week', 'otherNumAtRisk': 28, 'otherNumAffected': 9, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice', 'otherNumAtRisk': 28, 'otherNumAffected': 12, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anxiety with Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Family Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feeling Blue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feeling sick', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Knee pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Poor sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Worry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'overdose suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fell on ice, broke ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retention of Randomized Subjects During Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study'}, {'id': 'OG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week'}, {'id': 'OG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice'}], 'classes': [{'title': 'Retained', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Not retained', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks', 'description': 'Retained subjects are those who are willing to return for complete assessments', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Retention of Randomized Subjects for Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study'}, {'id': 'OG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week'}, {'id': 'OG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice'}], 'classes': [{'title': 'Retained for follow-up', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Lost to follow-up', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months', 'description': 'Subjects retained for follow-up are those willing to respond to follow-up assessments', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence to Out-of-class Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study'}, {'id': 'OG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week'}, {'id': 'OG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice'}], 'classes': [{'title': 'Adherent to out-of-class practice', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Not adherent to out-of-class practice', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks', 'description': 'Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence to Practice After the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study'}, {'id': 'OG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week'}, {'id': 'OG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice'}], 'classes': [{'title': 'Adherent to practice after the intervention', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Not adherent to practice after the intervention', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Individuals in the Anxiety Management Education group did not participate in tai chi classes or home practice.', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months', 'description': 'Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in State Anxiety Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study'}, {'id': 'OG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week'}, {'id': 'OG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice'}], 'classes': [{'title': 'Change from Baseline to 4 weeks', 'categories': [{'measurements': [{'value': '-1.93', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-2.70', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '-3.17', 'spread': '1.68', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 10 weeks', 'categories': [{'measurements': [{'value': '-1.43', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '-4.36', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '-3.04', 'spread': '1.73', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 2 Month Follow-up', 'categories': [{'measurements': [{'value': '-1.90', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-5.08', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '-3.58', 'spread': '1.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to 4 weeks, 10 weeks, 2 month follow-up', 'description': 'Anxiety was measured by the State Trait Anxiety Inventory - State Scale. Lower scores on this scale reflect better outcomes. Scores can range from 20 to 80.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pittsburgh Sleep Quality Index Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study'}, {'id': 'OG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week'}, {'id': 'OG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice'}], 'classes': [{'title': 'Change from Baseline to 4 weeks', 'categories': [{'measurements': [{'value': '-1.06', 'spread': '.45', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '.39', 'groupId': 'OG001'}, {'value': '-1.32', 'spread': '.36', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 10 weeks', 'categories': [{'measurements': [{'value': '-1.71', 'spread': '.46', 'groupId': 'OG000'}, {'value': '-2.98', 'spread': '.41', 'groupId': 'OG001'}, {'value': '-2.03', 'spread': '.38', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to 2 month follow-up', 'categories': [{'measurements': [{'value': '-1.82', 'spread': '.47', 'groupId': 'OG000'}, {'value': '-3.60', 'spread': '.45', 'groupId': 'OG001'}, {'value': '-3.05', 'spread': '.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks, 10 weeks, 2 month follow-up', 'description': 'Sleep quality was measured by the Pittsburgh Sleep Quality Index Total Score. Lower scores on this scale reflect better outcomes. Scores can range from 0 to 21.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study'}, {'id': 'FG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week'}, {'id': 'FG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Anxiety Management Education', 'description': 'Anxiety Management Education: written materials on management of anxiety for self-study'}, {'id': 'BG001', 'title': '10 Week Tai Chi Intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week\n\n10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week'}, {'id': 'BG002', 'title': 'Enhanced Tai Chi Instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice\n\nEnhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.42', 'spread': '5.47', 'groupId': 'BG000'}, {'value': '21.21', 'spread': '3.04', 'groupId': 'BG001'}, {'value': '20.18', 'spread': '1.16', 'groupId': 'BG002'}, {'value': '21.13', 'spread': '3.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-06', 'studyFirstSubmitDate': '2012-06-15', 'resultsFirstSubmitDate': '2015-08-31', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-31', 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of Randomized Subjects During Intervention', 'timeFrame': '10 weeks', 'description': 'Retained subjects are those who are willing to return for complete assessments'}, {'measure': 'Retention of Randomized Subjects for Follow-up', 'timeFrame': '2 months', 'description': 'Subjects retained for follow-up are those willing to respond to follow-up assessments'}, {'measure': 'Adherence to Out-of-class Practice', 'timeFrame': '10 weeks', 'description': 'Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention'}, {'measure': 'Adherence to Practice After the Intervention', 'timeFrame': '2 months', 'description': 'Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in State Anxiety Scores', 'timeFrame': 'change from baseline to 4 weeks, 10 weeks, 2 month follow-up', 'description': 'Anxiety was measured by the State Trait Anxiety Inventory - State Scale. Lower scores on this scale reflect better outcomes. Scores can range from 20 to 80.'}, {'measure': 'Change From Baseline in Pittsburgh Sleep Quality Index Scores', 'timeFrame': 'baseline, 4 weeks, 10 weeks, 2 month follow-up', 'description': 'Sleep quality was measured by the Pittsburgh Sleep Quality Index Total Score. Lower scores on this scale reflect better outcomes. Scores can range from 0 to 21.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anxiety', 'sleep quality', 'tai chi chuan', 'young adults'], 'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '20304755', 'type': 'BACKGROUND', 'citation': 'Caldwell K, Harrison M, Adams M, Quin RH, Greeson J. Developing mindfulness in college students through movement-based courses: effects on self-regulatory self-efficacy, mood, stress, and sleep quality. J Am Coll Health. 2010 Mar-Apr;58(5):433-42. doi: 10.1080/07448480903540481.'}, {'pmid': '19329051', 'type': 'BACKGROUND', 'citation': 'Caldwell K, Harrison M, Adams M, Triplett NT. Effect of Pilates and taiji quan training on self-efficacy, sleep quality, mood, and physical performance of college students. J Bodyw Mov Ther. 2009 Apr;13(2):155-63. doi: 10.1016/j.jbmt.2007.12.001. Epub 2008 Feb 20.'}, {'pmid': '21999153', 'type': 'BACKGROUND', 'citation': 'Caldwell K, Emery L, Harrison M, Greeson J. Changes in mindfulness, well-being, and sleep quality in college students through taijiquan courses: a cohort control study. J Altern Complement Med. 2011 Oct;17(10):931-8. doi: 10.1089/acm.2010.0645. Epub 2011 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility of a 10-week tai chi chuan intervention as a treatment for anxiety and sleep quality in young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to severe symptoms of anxiety\n* interest in participating in an exercise intervention\n* willingness to accept randomization\n* provides informed consent\n* low or moderate risk for acute cardiovascular event\n\nExclusion Criteria:\n\n* currently receiving psychotherapy or medication for psychological problems\n* current suicide or homicide risk\n* current or history of psychosis\n* current alcohol or substance dependence\n* high risk for an acute cardiovascular event\n* current use of prescription drugs with potential to influence the parasympathetic or sympathetic nervous system\n* current or previous extensive involvement in mind-body exercise\n* symptoms of severe depression'}, 'identificationModule': {'nctId': 'NCT01624168', 'briefTitle': 'Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Appalachian State University'}, 'officialTitle': 'Effects of Tai Chi Chuan on Psychobiological Indicators of Anxiety and Sleep Quality in Young Adults', 'orgStudyIdInfo': {'id': 'EBT Feasibility'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Anxiety Management Education', 'interventionNames': ['Behavioral: Anxiety Management Education']}, {'type': 'EXPERIMENTAL', 'label': '10 week tai chi intervention', 'description': '10 week course in Evidence Based Tai Chi meeting 2 times per week', 'interventionNames': ['Behavioral: 10 week tai chi intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced tai chi instruction', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice', 'interventionNames': ['Behavioral: Enhanced tai chi instruction']}], 'interventions': [{'name': 'Anxiety Management Education', 'type': 'BEHAVIORAL', 'description': 'written materials on management of anxiety for self-study', 'armGroupLabels': ['Anxiety Management Education']}, {'name': '10 week tai chi intervention', 'type': 'BEHAVIORAL', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week', 'armGroupLabels': ['10 week tai chi intervention']}, {'name': 'Enhanced tai chi instruction', 'type': 'BEHAVIORAL', 'description': '10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice', 'armGroupLabels': ['Enhanced tai chi instruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28608', 'city': 'Boone', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Appalachian State University', 'geoPoint': {'lat': 36.21679, 'lon': -81.67455}}], 'overallOfficials': [{'name': 'Karen L. Caldwell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Appalachian State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Appalachian State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Karen Caldwell', 'investigatorAffiliation': 'Appalachian State University'}}}}