Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-27 @ 12:42 AM
Study NCT ID:
NCT01955850
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2013-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online or Face-to-face Treatment 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2013-09-20', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)', 'timeFrame': 'Change from baseline to post-test, 3-months, and 6-months follow-up', 'description': 'For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'Change from baseline to post-test, 3-months, and 6-months follow-up'}], 'secondaryOutcomes': [{'measure': 'Anxiety (HADS-A)', 'timeFrame': 'Change from baseline to post-test, 3-months, and 6-months follow-up'}, {'measure': 'Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale', 'timeFrame': 'Change from baseline to post-test, 3-months, and 6-months follow-up'}, {'measure': 'Sleep related arousal measured with the Pre-arousal sleep scale', 'timeFrame': 'Change from baseline to post-test, 3-months, and 6-months follow-up'}, {'measure': 'Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)', 'timeFrame': 'Change from baseline to post-test, 3-months, and 6-months follow-up'}, {'measure': 'Sleep medication usage per day measured with the sleep diary', 'timeFrame': 'Change from baseline to post-test, 3-months, and 6-months follow-up'}, {'measure': 'Depression measured with the CES-D', 'timeFrame': 'Change from baseline to post-test, 3-months, and 6-months follow-up'}]}, 'conditionsModule': {'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '22055281', 'type': 'BACKGROUND', 'citation': 'Lancee J, van den Bout J, van Straten A, Spoormaker VI. Internet-delivered or mailed self-help treatment for insomnia?: a randomized waiting-list controlled trial. Behav Res Ther. 2012 Jan;50(1):22-9. doi: 10.1016/j.brat.2011.09.012. Epub 2011 Oct 24.'}, {'pmid': '26414893', 'type': 'DERIVED', 'citation': 'Lancee J, van Straten A, Morina N, Kaldo V, Kamphuis JH. Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial. Sleep. 2016 Jan 1;39(1):183-91. doi: 10.5665/sleep.5344.'}], 'seeAlsoLinks': [{'url': 'http://www.insomnie.nl', 'label': 'General website for insomnia and used for the recruitment'}]}, 'descriptionModule': {'briefSummary': 'The object of this study is to compare internet-delivered treatment for insomnia to face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Both the online and face-to-face interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. Participants on the waiting-list receive online treatment after the first post-test. The investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insomnia disorder according to DSM-5\n* Sleep onset latency/wake after sleep onset \\> 30 minutes , three times or more a week\n* Insomnia three months or longer\n* Access to internet\n* Possibility to travel to one of the treatment sites\n\nExclusion Criteria:\n\n* Earlier cognitive behavioral treatment for insomnia\n* Start other psychological treatment in the last 6 months\n* Doing shift work\n* Major depression disorder\n* Pregnancy or breast feeding\n* Schizophrenia or psychosis\n* Suicidal plans\n* Sleep apnea\n* drugs or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01955850', 'briefTitle': 'Online or Face-to-face Treatment for Insomnia?', 'organization': {'class': 'OTHER', 'fullName': 'VU University of Amsterdam'}, 'officialTitle': 'Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial', 'orgStudyIdInfo': {'id': 'UvA-2013-KP-3125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-delivered CBT for insomnia', 'description': 'Online Cognitive behavioral treatment for insomnia', 'interventionNames': ['Behavioral: Cognitive behavioral treatment for insomnia']}, {'type': 'EXPERIMENTAL', 'label': 'Face-to-face CBT for insomnia', 'description': 'Face-to-face Cognitive behavioral treatment for insomnia', 'interventionNames': ['Behavioral: Cognitive behavioral treatment for insomnia']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting-list', 'description': 'Waiting-list'}], 'interventions': [{'name': 'Cognitive behavioral treatment for insomnia', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.', 'armGroupLabels': ['Face-to-face CBT for insomnia', 'Internet-delivered CBT for insomnia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1018XA', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Department of Clinical Psychology', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Jaap Lancee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VU University of Amsterdam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Slaapmakend', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Jaap Lancee', 'investigatorAffiliation': 'VU University of Amsterdam'}}}}