Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT05363995
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2022-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Trial i-Sleep & BioClock Intervention
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm open feasibility study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': '7 weeks after baseline (T1)', 'description': '8-item self-report questionnaire for client satisfaction with services, total score ranging from 8-32, higher indicating higher satisfaction'}, {'measure': 'System Usability Scale (SUS-10)', 'timeFrame': '7 weeks after baseline (T1)', 'description': '10-item self-report scale for system usability, five response options for respondents; from strongly agree to strongly disagree, scores ranging from 0-40, higher scores indicating better system usability'}, {'measure': 'Working Alliance Inventory for guided Internet interventions (WAI-I)', 'timeFrame': '7 weeks after baseline (T1)', 'description': '12-item self-report instrument to capture alliance in guided Internet interventions, 5-point Likert scale ranging from 1 (never) to 5 (always), scores ranging from 12-60, higher scores indicating better alliance'}, {'measure': 'Acceptability and usability of the sleep & light exposure diary', 'timeFrame': '7 weeks after baseline (T1)', 'description': '11 items on the sleep \\& light exposure diary, 5 point Likert Scale, scores ranging from 0-44, higher scores indicating better usability and acceptability, one visual scale on usefulness of the diary, 0 (not at all useful) to 10 (Very much useful)'}, {'measure': 'Adherence to the program', 'timeFrame': 'Through study completion, on average 7 weeks', 'description': 'Will be measured by the total number of completed modules and lessons, time spent in the platform, and the number of logins'}], 'primaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': 'Change from baseline (T0) to 7 weeks after baseline (T1)', 'description': '7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity'}], 'secondaryOutcomes': [{'measure': 'Sleep and light exposure diary', 'timeFrame': 'Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1)', 'description': 'This diary includes measures such as sleep efficiency, sleep onset latency, total sleep time, wake after sleep onset, number of awakenings, early morning awakening, time spent outside, screen use before bedtime)'}, {'measure': 'Munich Chronotype Questionnaire (MCTQ)', 'timeFrame': 'Change from baseline (T0) to 7 weeks after baseline (T1)', 'description': 'Self-rated scale to assess individual phase of entrainment on work and work-free days, Addresses questions about: bedtime, time spent in bed awake before deciding to turn off the lights, how long it takes to fall asleep, wake up time, get up time on work and work-free days. MCTQ uses the midpoint between sleep on- and offset on free days (mid-sleep on free days, MSF) to assess chronotype'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Change from baseline (T0) to 7 weeks after baseline (T1)', 'description': '9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression'}, {'measure': 'Generalised Anxiety Disorder scale (GAD-7)', 'timeFrame': 'Change from baseline (T0) to 7 weeks after baseline (T1)', 'description': '7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety'}, {'measure': 'Work and Social Adjustment Scale (WSAS)', 'timeFrame': 'Change from baseline (T0) to 7 weeks after baseline (T1)', 'description': '5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning'}, {'measure': 'Mental Health Quality of Life questionnaire (MHQoL)', 'timeFrame': 'Change from baseline (T0) to 7 weeks after baseline (T1)', 'description': '7-item self report instrument for quality of life measure for use in people with mental health problems, scores ranging from 0-21, higher scores indicating higher quality of life, and MHQoL-VAS visual scale ranging from 0 (worst imaginable psychological wellbeing) to 10 (best imaginable psychological wellbeing)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'biological clock', 'CBTi', 'e-health intervention', 'university students'], 'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '40593043', 'type': 'DERIVED', 'citation': 'Pape LM, Antypa N, Spinhoven P, van Straten A, Struijs SY; Caring Universities Consortium. Open pilot study of a guided digital self-help intervention targeting sleep and the biological clock in university students using a pre-test post-test design. Sci Rep. 2025 Jul 1;15(1):21837. doi: 10.1038/s41598-025-04891-8.'}]}, 'descriptionModule': {'briefSummary': 'Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.', 'detailedDescription': 'The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being fluent in Dutch and/or English\n* Being enrolled as a student (Bachelor, Master or PhD) in one of the seven participating universities (Leiden University, Vrije Universiteit Amsterdam, Utrecht University, Maastricht University, Erasmus University Rotterdam, University of Amsterdam, Inholland University of Applied Sciences)\n* Being ≥ 16 years old\n* Having self-reported sleep problems; Insomnia Severity Index ≥ 8 (at least subthreshold insomnia)\n\nExclusion Criteria:\n\n* Current risk for suicidal behaviour'}, 'identificationModule': {'nctId': 'NCT05363995', 'briefTitle': 'Feasibility Trial i-Sleep & BioClock Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among University Students (i-Sleep & BioClock)', 'orgStudyIdInfo': {'id': 'BioClockWP1.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Blended e-health intervention', 'interventionNames': ['Behavioral: i-Sleep & BioClock Intervention']}], 'interventions': [{'name': 'i-Sleep & BioClock Intervention', 'type': 'BEHAVIORAL', 'description': "The 'i-Sleep \\& BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules:\n\n1. psychoeducation on insomnia, sleep hygiene and the biological clock,\n2. stimulus control and sleep restriction therapy,\n3. worrying and relaxation exercises,\n4. cognitive therapy to change dysfunctional thoughts about sleep, and\n5. summary module, relapse prevention, and plan for the future.\n\nThe intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep \\& light exposure diary daily.", 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333AK', 'city': 'Leiden', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Leiden Univeristy'}], 'overallOfficials': [{'name': 'Niki Antypa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Philip Spinhoven', 'investigatorFullName': 'Philip Spinhoven', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}