Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:12 AM
Study NCT ID:
NCT01224912
Status:
COMPLETED
Last Update Posted:
2013-01-08
First Post:
2010-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet Delivered Self-Help CBT for Insomnia
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 479}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-07', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep diary', 'timeFrame': 'baseline', 'description': 'Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.'}, {'measure': 'Sleep diary', 'timeFrame': '4-week follow-up', 'description': 'Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.'}, {'measure': 'Sleep diary', 'timeFrame': '18-week follow-up', 'description': 'Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.'}, {'measure': 'Sleep diary', 'timeFrame': '48-week follow-up', 'description': 'Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.'}], 'secondaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Baseline', 'description': 'Measured with the HADS'}, {'measure': 'Anxiety', 'timeFrame': '4-week follow-up', 'description': 'HADS'}, {'measure': 'Anxiety', 'timeFrame': '18-week follow-up', 'description': 'HADS'}, {'measure': 'Anxiety', 'timeFrame': '48-week follow-up', 'description': 'HADS'}, {'measure': 'Depression', 'timeFrame': 'Baseline', 'description': 'CES-D'}, {'measure': 'Depression', 'timeFrame': '4 week follow-up', 'description': 'CES-D'}, {'measure': 'Depression', 'timeFrame': '18-week follow-up', 'description': 'CES-D'}, {'measure': 'Depression', 'timeFrame': '48-week follow-up', 'description': 'CES-D'}, {'measure': 'Sleep medication', 'timeFrame': 'Baseline', 'description': 'Sleep medication as measured by the sleep diary'}, {'measure': 'Sleep medication', 'timeFrame': '4-week follow-up', 'description': 'Sleep medication as measured by the sleep diary'}, {'measure': 'Sleep medication', 'timeFrame': '18-week follow-up', 'description': 'Sleep medication as measured by the sleep diary'}, {'measure': 'Sleep medication', 'timeFrame': '48-week follow-up', 'description': 'Sleep medication as measured by the sleep diary'}, {'measure': 'Insomnia Severity', 'timeFrame': 'Baseline', 'description': 'Insomnia Severity Index'}, {'measure': 'Insomnia severity', 'timeFrame': 'four-week follow-up', 'description': 'Insomnia Severity Index'}, {'measure': 'Insomnia severity', 'timeFrame': '18-week follow-up', 'description': 'Insomnia Severity Index'}, {'measure': 'Insomnia severity', 'timeFrame': '48-week follow-up', 'description': 'Insomnia Severity Index'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Insomnia', 'Intervention', 'Self-help', 'Internet'], 'conditions': ['Insomnia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.insomnie.nl', 'label': 'Popular scientific website about insomnia'}]}, 'descriptionModule': {'briefSummary': 'The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insomnia\n* Access to the internet\n\nExclusion Criteria:\n\n* Alcohol or substance abuse\n* Being suicidal\n* Sleep apnea\n* Schizophrenic or having a psychosis disorder'}, 'identificationModule': {'nctId': 'NCT01224912', 'briefTitle': 'Internet Delivered Self-Help CBT for Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'Utrecht University'}, 'officialTitle': 'Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention', 'orgStudyIdInfo': {'id': 'UU-vandenBout-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet Deliviered CBT for Insomnia', 'description': 'Cognitive behavioral self-help method for insomnia via the Internet', 'interventionNames': ['Behavioral: Cognitive Behavioral Treatment']}], 'interventions': [{'name': 'Cognitive Behavioral Treatment', 'type': 'BEHAVIORAL', 'description': "The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).", 'armGroupLabels': ['Internet Deliviered CBT for Insomnia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3508TC', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'Utrecht University', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Jaap Lancee, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utrecht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Utrecht University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Utrecht University', 'oldOrganization': 'Utrecht University'}}}}