Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT03633305
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2018-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Insomnia Treatment in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006993', 'term': 'Hypnotics and Sedatives'}], 'ancestors': [{'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The study involves two treatment phases of six to eight weeks. In the first phase, participants choose medication (treatment as usual), online cognitive behavior therapy, or online cognitive behavior therapy combined with medication. Participants enter a second treatment phase if they still experience insomnia after the first treatment. The treatment arms for the second phase are medication, in-person cognitive-behavior therapy, or no additional treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission of insomnia', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Insomnia Severity Index score (average of two consecutive weeks \\< 8, with none \\> 10)'}, {'measure': 'Remission of insomnia', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Insomnia Severity Index score (average of two consecutive weeks \\< 8, with none \\> 10)'}], 'secondaryOutcomes': [{'measure': 'Total sleep time from sleep diary', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Mean total sleep time per night in minutes from sleep diary'}, {'measure': 'Total sleep time from sleep diary', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Mean total sleep time per night in minutes from sleep diary'}, {'measure': 'Total wake time from sleep diary', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary'}, {'measure': 'Total wake time from sleep diary', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary'}, {'measure': 'Sleep efficiency from sleep diary', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary'}, {'measure': 'Sleep efficiency from sleep diary', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary'}, {'measure': 'Total sleep time from actigraphy', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Mean total sleep time per night in minutes from actigraphy'}, {'measure': 'Total sleep time from actigraphy', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Mean total sleep time per night in minutes from actigraphy'}, {'measure': 'Total wake time from actigraphy', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy'}, {'measure': 'Total wake time from actigraphy', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy'}, {'measure': 'Sleep efficiency from actigraphy', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy'}, {'measure': 'Sleep efficiency from actigraphy', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy'}, {'measure': 'Fatigue', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Flinders Fatigue Scale (7-item self-report scale measuring fatigue over the past two weeks; total score ranges from 0 to 31, higher scores indicating greater fatigue)'}, {'measure': 'Fatigue', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Flinders Fatigue Scale (7-item self-report scale measuring fatigue over the past two weeks; total score ranges from 0 to 31, higher scores indicating greater fatigue)'}, {'measure': 'Depression', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Patient Health Questionnaire (PHQ-9)'}, {'measure': 'Depression', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Patient Health Questionnaire (PHQ-9)'}, {'measure': 'Anxiety', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Generalized Anxiety Disorder 7-item (GAD-7)'}, {'measure': 'Anxiety', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Generalized Anxiety Disorder 7-item (GAD-7)'}, {'measure': 'Disability', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Work and Social Adjustment Scale (5-item scale scale assessing functional impact of insomnia; total score ranging from 0 to 40, higher scores indicating greater disability)'}, {'measure': 'Disability', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Work and Social Adjustment Scale (5-item scale scale assessing functional impact of insomnia; total score ranging from 0 to 40, higher scores indicating greater disability)'}, {'measure': 'Medication use', 'timeFrame': 'Post-1 (after 6-week treatment phase 1)', 'description': 'Frequency of use (number of nights/week)'}, {'measure': 'Medication use', 'timeFrame': 'Post-2 (after 6-week treatment phase 2)', 'description': 'Frequency of use (number of nights/week)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Pragmatic Clinical Trial', 'Drug Therapy', 'Cognitive Behavior Therapy', 'Primary Care'], 'conditions': ['Insomnia Disorder']}, 'referencesModule': {'references': [{'pmid': '40570832', 'type': 'DERIVED', 'citation': 'Cheung JMY, Ritterband LM, Chen SJ, Ivers H, Morin CM. Stepped-Care Management of Insomnia: Treatment Choices Guided by a Patient Decision Aid in a Pragmatic Nonrandomized Clinical Trial Setting. J Sleep Res. 2025 Jun 26:e70127. doi: 10.1111/jsr.70127. Online ahead of print.'}, {'pmid': '40373353', 'type': 'DERIVED', 'citation': 'Morin CM, Chen SJ, Lemieux K, Ivers H, Cheung JMY, Lamy M, Ritterband L. Stepped care for insomnia in primary care using digital and face-to-face cognitive behavioral therapies: A pragmatic nonrandomized clinical trial. Sleep Med. 2025 Aug;132:106551. doi: 10.1016/j.sleep.2025.106551. Epub 2025 May 3.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this pragmatic clinical trial is to evaluate the efficacy, feasibility, and adaptability of pharmacological and non-pharmacological treatments for insomnia disorder, delivered in primary care clinics. The second objective is to evaluate the efficacy of a sequential (stepped care) approach for persistent insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or over\n* Meeting criteria for insomnia disorder\n* Registered patient at one of the primary care clinics participating in the study\n* Fluent in French\n* Computer and internet access\n\nExclusion Criteria:\n\n* Unstable or untreated psychiatric disorder\n* Lifetime psychotic or bipolar disorder\n* Current suicide risk\n* Progressive or unstable medical disorder\n* Untreated sleep disorder other than insomnia\n* Use of medication altering sleep\n* Irregular or atypical sleep-wake schedule\n* Current or planned pregnancy'}, 'identificationModule': {'nctId': 'NCT03633305', 'briefTitle': 'Optimization of Insomnia Treatment in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial', 'orgStudyIdInfo': {'id': 'CIHR0083000212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks', 'interventionNames': ['Drug: Hypnotics']}, {'type': 'EXPERIMENTAL', 'label': 'Online cognitive behavior therapy', 'description': 'Online CBT- Internet self-help program for insomnia with 6 cores', 'interventionNames': ['Behavioral: Online CBT']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment as usual + Online CBT', 'description': 'Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores', 'interventionNames': ['Drug: Hypnotics', 'Behavioral: Online CBT']}, {'type': 'EXPERIMENTAL', 'label': 'Medication', 'description': 'Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)', 'interventionNames': ['Drug: Hypnotics']}, {'type': 'EXPERIMENTAL', 'label': 'In-person cognitive behavior therapy', 'description': 'Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.', 'interventionNames': ['Behavioral: Face-to-face CBT']}, {'type': 'NO_INTERVENTION', 'label': 'No additional treatment'}], 'interventions': [{'name': 'Hypnotics', 'type': 'DRUG', 'description': 'Medication used 1 to 7 nights/week for 6 to 8 weeks.', 'armGroupLabels': ['Medication', 'Treatment as usual', 'Treatment as usual + Online CBT']}, {'name': 'Online CBT', 'type': 'BEHAVIORAL', 'description': 'Internet self-help program for insomnia with 6 cores.', 'armGroupLabels': ['Online cognitive behavior therapy', 'Treatment as usual + Online CBT']}, {'name': 'Face-to-face CBT', 'type': 'BEHAVIORAL', 'description': 'Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.', 'armGroupLabels': ['In-person cognitive behavior therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1K 0A6', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Manon Lamy', 'role': 'CONTACT', 'email': 'manon.lamy@psy.ulaval.ca', 'phone': '418 656-2131', 'phoneExt': '12467'}, {'name': 'Charles M Morin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laval University', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Manon Lamy', 'role': 'CONTACT', 'email': 'manon.lamy@psy.ulaval.ca', 'phone': '418-656-2131', 'phoneExt': '12467'}], 'overallOfficials': [{'name': 'Charles Morin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Université Laval Centre d'étude des troubles du sommeil"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Charles M. Morin', 'investigatorAffiliation': 'Laval University'}}}}