Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 4:19 AM
Study NCT ID:
NCT01188460
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2010-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kewilson@toh.ca', 'title': 'Dr. Keith Wilson', 'organization': 'OHRI'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insomnia Severity Index (ISI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '19.84', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '16.04', 'spread': '5.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation)', 'description': 'Measures insomnia symptoms, scores range from 0-28 with higher scores (ranging from 15-28) indicating clinical insomnia and therefore worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Diary- Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '5.34', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '5.46', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nTotal Sleep Time in hours, higher scores indicate better outcomes', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Diary- Time to Fall Asleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nTime to Fall Asleep in minutes, higher scores indicate worse outcomes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Diary- Number of Nocturnal Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '1', 'groupId': 'OG000'}, {'value': '3', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nNumber of Nocturnal Awakenings, higher scores indicate worse outcomes', 'unitOfMeasure': 'Number of nocturnal awakenings', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Diary- Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '63.06', 'spread': '8.33', 'groupId': 'OG000'}, {'value': '67.09', 'spread': '8.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nSleep Efficiency (percentage)- higher scores indicate better outcomes', 'unitOfMeasure': 'Percentage of efficiency', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Diary- Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '1', 'groupId': 'OG000'}, {'value': '4', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nSleep Quality (units on a scale from 0-10), higher scores indicate better outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Severity Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '27.96', 'spread': '5.19', 'groupId': 'OG000'}, {'value': '25.35', 'spread': '6.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures pain severity, rated on scale from 0-10, total scores range from 0-40, higher scores indicate worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Disability Index (PDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '48.12', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '46.13', 'spread': '10.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures pain disability impact on various life domains, scores range from 0-70, higher scores indicate worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '22.08', 'spread': '7.43', 'groupId': 'OG000'}, {'value': '19.43', 'spread': '5.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures symptoms of depression and anxiety, total scores range from 0-42, higher scores indicate worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pre-Sleep Arousal Scale (PSAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '44.84', 'spread': '11.52', 'groupId': 'OG000'}, {'value': '35.43', 'spread': '9.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures pre-sleep hyperarousal, total scores range from 16-80, higher scores indicate worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fatigue Severity Scale (FSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'OG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'classes': [{'categories': [{'measurements': [{'value': '50.60', 'spread': '8.74', 'groupId': 'OG000'}, {'value': '47.30', 'spread': '10.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures symptoms of fatigue, total scores range from 9-63, higher scores indicate worse outcomes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'FG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints\n\nSleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'BG001', 'title': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints\n\nSelf-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.29', 'spread': '9.55', 'groupId': 'BG000'}, {'value': '47.96', 'spread': '10.21', 'groupId': 'BG001'}, {'value': '46.09', 'spread': '9.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Missing data for age for one participant'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2010-08-19', 'resultsFirstSubmitDate': '2017-01-20', 'studyFirstSubmitQcDate': '2010-08-23', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-10', 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Timepoint 2 (week 7 of study participation)', 'description': 'Measures insomnia symptoms, scores range from 0-28 with higher scores (ranging from 15-28) indicating clinical insomnia and therefore worse outcomes'}, {'measure': 'Sleep Diary- Total Sleep Time', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nTotal Sleep Time in hours, higher scores indicate better outcomes'}, {'measure': 'Sleep Diary- Time to Fall Asleep', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nTime to Fall Asleep in minutes, higher scores indicate worse outcomes'}, {'measure': 'Sleep Diary- Number of Nocturnal Awakenings', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nNumber of Nocturnal Awakenings, higher scores indicate worse outcomes'}, {'measure': 'Sleep Diary- Sleep Efficiency', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nSleep Efficiency (percentage)- higher scores indicate better outcomes'}, {'measure': 'Sleep Diary- Sleep Quality', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures:\n\nSleep Quality (units on a scale from 0-10), higher scores indicate better outcomes'}], 'secondaryOutcomes': [{'measure': 'Pain Severity Rating', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures pain severity, rated on scale from 0-10, total scores range from 0-40, higher scores indicate worse outcomes'}, {'measure': 'Pain Disability Index (PDI)', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures pain disability impact on various life domains, scores range from 0-70, higher scores indicate worse outcomes'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures symptoms of depression and anxiety, total scores range from 0-42, higher scores indicate worse outcomes'}, {'measure': 'Pre-Sleep Arousal Scale (PSAS)', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures pre-sleep hyperarousal, total scores range from 16-80, higher scores indicate worse outcomes'}, {'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': 'Timepoint 2 (week 7 of study participation).', 'description': 'Measures symptoms of fatigue, total scores range from 9-63, higher scores indicate worse outcomes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Chronic pain'], 'conditions': ['Insomnia', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This study will test the impact of a cognitive-behavioural self-management approach for the management of insomnia among patients with chronic pain. This self-management approach consists of a manual describing cognitive behavioural techniques for the management of insomnia. In terms of primary outcomes, it is anticipated that there would be improvements in sleep-related dimensions such as sleep quality, sleep efficiency, and night-time awakenings in the sample group receiving a copy of the self-help manual intervention to be implemented by participants in their home (intervention group), relative to the group receiving treatment as usual (control group). In terms of secondary outcomes, it is anticipated that the intervention group will show improvements in mood, fatigue, pain severity, and pain-related disability relative to the control group. The tertiary outcome variable of pre-sleep arousal is anticipated to have a moderating or mediating relationship with the sleep variables investigated.', 'detailedDescription': "In summary therefore, insomnia and other sleep difficulties have been reported to frequently occur in conjunction with other medical or psychiatric disorders, however insomnia co-occurring with other medical or psychiatric conditions has received less attention relative to primary insomnia with no such concurrent conditions (e.g., Lichstein, 2006; McCrae, \\& Lichstein, 2001; Taylor, Mallory, Lichstein, Durrence, Riedel, \\& Bush, 2007). In chronic pain, there have not been many well-controlled studies involving insomnia existing with a concurrent chronically painful condition. Research thus far has found multi-component cognitive-behavioural approaches to be successful in treating primary insomnia, and there have been some studies applying these approaches in the context of insomnia and concurrent medical conditions (Currie, Wilson, Pontefract, \\& deLaplante, 2000; Morin, 1993). Based on Morin's work (Morin, 1993; Morin, Beaulieu-Bonneau, LeBlanc, \\& Savard, 2005) involving a cognitive-behaviour therapy (CBT) protocol for patients with sleep problems related to chronic pain, a self-help format of such an intervention has also been developed (Currie \\& Wilson, 1997). However, this has thus far only been delivered within a group-based treatment programme (Currie, 1998; Currie \\& Wilson, 1997; Currie, Wilson, Pontefract, \\& deLaplante, 2000). From this context, and building on a prior study involving a group treatment format (Currie, 1998; Currie, Wilson, Pontefract, \\& deLaplante, 2000), the usefulness of a manualized self-management approach in manageing insomnia will be investigated, including the impact of this approach with regard to other salient measures of improved functioning (such as pain severity or pain-related disability) for individuals with chronic pain. The proposed study will involve a randomized control trial of this self-help treatment strategy for comorbid insomnia in chronically painful medical conditions among an adult outpatient sample at a hospital rehabilitation centre and pain clinic. This study thus seeks to investigate how successful a cognitive-behaviour therapy (CBT) self-help management approach is for manageing insomnia amongst people with chronic pain. Given the public health implications of the relationship of poor sleep to quality of life (e.g., Morin, Stone, McDonald, \\& Jones, 1994; Quesnel, Savard, Simard, Ivers, \\& Morin, 2003), a self-management approach to insomnia in the context of chronic pain may offer an accessible and cost-effective treatment option.\n\nThe following hypotheses will be tested:\n\nThe first hypothesis predicts that participants in the intervention group will show changes in their scores on psychological measures in terms of greater improvements in sleep-related dimensions, in comparison with controls between the baseline and post-treatment periods.\n\nThe second hypothesis predicts that participants in the intervention group will show changes in their scores on psychological measures in terms of lower levels of anxiety, depression, fatigue, pain severity, and pain-related disability, in comparison with controls between the baseline and post-treatment periods. These secondary outcome variables are not directly targeted by the intervention, however it is proposed that if improvements in sleep are experienced, there would be subsequent improvements in the variables of mood, fatigue, pain severity, and pain-related disability among chronic pain patients who experience insomnia.\n\nThe third hypothesis predicts that the variable of pre-sleep arousal will have a moderating or mediating influence on the sleep-related variables (which will be the primary outcome variables). The moderating or mediating variable of pre-sleep arousal is proposed to assess dimensions related to sleep that are not tapped into by the primary outcome, sleep-related variables, but that may be of salience in the context of insomnia that is comorbid with chronically painful conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years of age\n* Not in state of crisis\n* Able to read and understand English\n* Experiences sleep difficulties or insomnia\n* Has chronic pain\n\nExclusion Criteria:\n\n* Under 18 or over 65 years of age\n* In a state of crisis\n* Does not read or understand English\n* Does not experience sleep difficulties or insomnia\n* Does not have chronic pain'}, 'identificationModule': {'nctId': 'NCT01188460', 'briefTitle': 'A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '2009902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only (sleep diary measures Total Sleep Time in hours, Time to Fall Asleep in minutes, Number of Nocturnal Awakenings, Sleep Efficiency as a percentage, and Sleep Quality as units on a scale), complete questionnaires at three study timepoints', 'interventionNames': ['Behavioral: Sleep diary']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries (sleep diary measures Total Sleep Time in hours, Time to Fall Asleep in minutes, Number of Nocturnal Awakenings, Sleep Efficiency as a percentage, and Sleep Quality as units on a scale), implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints', 'interventionNames': ['Behavioral: Self-help manual for insomnia', 'Behavioral: Sleep diary']}], 'interventions': [{'name': 'Self-help manual for insomnia', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention Group'], 'description': 'Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality', 'armGroupLabels': ['Experimental Group']}, {'name': 'Sleep diary', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital, Pain Clinic', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K1H 8M2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital Rehabilitation Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Keith E Wilson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital Rehabilitation Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ottawa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}