Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-04-13 @ 11:19 PM
Study NCT ID:
NCT01719120
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-Based Cognitive-Behavioral Therapy 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2012-10-29', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) changes from baseline to 5-week posttreatment by subjective measures using sleep log.', 'timeFrame': 'Baseline, 1-week, 5-week, and 12-week posttreatment.', 'description': '12-week posttreatment is only for within-group comparison in treatment groups'}], 'secondaryOutcomes': [{'measure': 'Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire', 'timeFrame': 'Baseline, 1-week, 5-week, and 12-week posttreatment.', 'description': '12-week posttreatment is only for within-group comparison in treatment groups'}, {'measure': 'Self-rated sleep-related cognition score measured by Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)', 'timeFrame': 'Baseline, 1-week, 5-week, and 12-week posttreatment.', 'description': '12-week posttreatment is only for within-group comparison in treatment groups'}, {'measure': 'Self-rated severity of depressive and anxiety symptoms measured by Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline, 1-week, 5-week, and 12-week posttreatment', 'description': '12-week posttreatment is only for within-group comparison in treatment groups'}, {'measure': "Subjects' general health and quality of life regarding physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, vitality, bodily pain, and general health perception measured by Short form -36 (SF-36)", 'timeFrame': 'Baseline, 1-week, 5-week, and 12-week posttreatment.', 'description': '12-week posttreatment is only for within-group comparison in treatment groups'}, {'measure': 'Self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)', 'timeFrame': 'Baseline, 1-week, 5-week, and 12-week posttreatment.', 'description': '12-week posttreatment is only for within-group comparison in treatment groups'}, {'measure': "Subjects' acceptability and credibility to the treatment measured by Treatment acceptability and credibility rating scale", 'timeFrame': 'Baseline and 1-week posttreatment'}, {'measure': "Subjects' adherence to the treatment measured by Treatment adherence rating scale", 'timeFrame': '1-week posttreatment'}, {'measure': "Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale", 'timeFrame': 'Treatment Week 2-6'}, {'measure': 'Potential side effects associated with each component of CBT measured by Symptom checklist', 'timeFrame': 'Treatment Week 2-6 and 1-week posttreatment'}, {'measure': 'Self-rated sleep quality score changes from baseline to 12-week posttreatment measured by Insomnia Severity Index questionnaire', 'timeFrame': 'Baseline, treatment Week 3, 1-week, 5-week and 12 week posttreatment.', 'description': '12-week posttreatment is only for within-group comparison in treatment groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insomnia', 'Cognitive-Behavioral Therapy', 'Internet-Based', 'Self-Help', 'Randomized Controlled Trial'], 'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '25461790', 'type': 'RESULT', 'citation': 'Ho FY, Chung KF, Yeung WF, Ng TH, Cheng SK. Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy. Behav Res Ther. 2014 Dec;63:147-56. doi: 10.1016/j.brat.2014.10.002. Epub 2014 Oct 23.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to develop an Internet-based self-help therapy program for insomnia in Chinese language, and to conduct a randomized waiting-list controlled trial on the efficacy of Internet-based self-help therapy for insomnia.', 'detailedDescription': 'This study is a randomized controlled trial in patients with insomnia. Eligible subjects will be randomly assigned to self-help treatment with telephone consultation (SHTC), self-help treatment without telephone consultation (SH), or waiting-list control. The subjects will receive self-help treatment once per week for 6 consecutive weeks. In addition to self-help treatment, the subjects in SHTC group will receive telephone consultation once per week for 6 consecutive weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hong Kong residents aged ≥18 years\n* Predominant complaint of difficulty initiating or maintaining sleep or early morning awakening or nonrestorative sleep with associated distress or impairment in social, occupational and other important areas of functioning for at least 3 nights per week for at least 3 months based on self- administered questionnaire\n* Able to read Chinese and type Chinese or English\n* Have Internet access (PC/ mobile phone), and with an email address\n* Willing to give informed consent and comply with the trial protocol\n\nExclusion Criteria:\n\n* Have suicidal ideas based on self-report'}, 'identificationModule': {'nctId': 'NCT01719120', 'briefTitle': 'Internet-Based Cognitive-Behavioral Therapy for Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Internet-Based Self-Help Cognitive-Behavioral Therapy for Insomnia (CBTI): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CBTI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-help CBT with tel. consultation', 'description': 'Self-help CBT with tel. consultation (SHTC)group will receive telephone consultation provided by the investigator in addition to self-help cognitive-behavioral therapy once per week for 6 consecutive weeks.During the consultation, the investigator will answer questions about the treatment content, monitor whether the subjects read the assigned materials and comply with the tasks and procedures, and provide encouragement and support.', 'interventionNames': ['Behavioral: Cognitive-Behavioral Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Self-help CBT', 'description': 'The subjects will receive self-help cognitive-behavioral therapy (SH)once per week for 6 consecutive weeks.', 'interventionNames': ['Behavioral: Cognitive-Behavioral Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting-list control (WL)', 'description': 'Subjects in this group will not receive any kind of treatment during the waiting period. They will receive the treatment identical to the self-help group within 3 months from the baseline.'}], 'interventions': [{'name': 'Cognitive-Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'CBT for insomnia aims at changing dysfunctional cognitive beliefs and maladaptive behaviors contributed to the maintenance of insomnia. It involves 4 main components including behavioral, cognitive, educational, and relaxation treatments.', 'armGroupLabels': ['Self-help CBT', 'Self-help CBT with tel. consultation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'the University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Ka-Fai Chung, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}