Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 4:44 PM
Study NCT ID:
NCT04771234
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Psychological Self-care for Sleep Problems
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment Pragmatic, within-group pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events and Negative effects questionnaire (NEQ)', 'timeFrame': 'From base-line to 4 weeks', 'description': 'Self-report measures of negative effects and adverse events; Higher values represent more adverse events and negative effects'}, {'measure': 'Actigraphy', 'timeFrame': 'From base-line to 4 weeks', 'description': 'A wrist-worn device to measure sleep, giving measures of e.g. total sleep time, wake after sleep onset, and sleep efficiency'}], 'primaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': 'From base-line to 4 weeks', 'description': '7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'From base-line to 20 weeks', 'description': '7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represent higher severity (worse outcome)'}, {'measure': 'Treatment acceptability/usefulness', 'timeFrame': 'From base-line to 4 weeks', 'description': 'Qualitative quesions regarding participant perception of using the digital tool (ease of use, whether the tool was helpful)'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'From base-line to 4 weeks', 'description': '9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'From base-line to 20 weeks', 'description': '9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)'}, {'measure': 'Generalized Anxiety Disorder Scale (GAD7)', 'timeFrame': 'From base-line to 4 weeks', 'description': '7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)'}, {'measure': 'Generalized Anxiety Disorder Scale (GAD7)', 'timeFrame': 'From base-line to 20 weeks', 'description': '7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital tool', 'Self-guided'], 'conditions': ['Chronic Insomnia']}, 'descriptionModule': {'briefSummary': "In this non-randomized treatment feasibility pilot we want to explore if a simplified version of CBT-i as a non-therapist-guided digital tool can work; if the digital tool is perceived as user friendly and if participants' insomnia severity is improved following four weeks of treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insomnia complaints of at least medium severity (15 or above on the ISI)\n* Insomnia disorder according to DSM-5\n* Adequate language skills (Swedish)\n* No foreseeable practical hinders to participate\n* Can wear actigraph 24/7\n* Daily access to the internet, via computer, smart phone or tablet\n\nExclusion Criteria:\n\n* Sleep disorders requiring other treatment (e.g. sleep apnea)\n* Somatic or psychiatric disorders that require other treatment (e.g. suicide risk, severe depression) or that decrease level of functioning enough to prevent working independently.\n* Use of alcohol or drugs in a way that will affect sleep negatively, use of medications with a negative impact on sleep. (Stable use of anti depressants and stable use or tapering of hypnotics are allowed)\n* Night work or shift work involving night work\n* Ongoing or previous psychological treatment including sleep restricion and stimulus control'}, 'identificationModule': {'nctId': 'NCT04771234', 'briefTitle': 'Digital Psychological Self-care for Sleep Problems', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Self-guided Digital Psychological Self-care for Individuals With Sleep Problems - Feasibility and Preliminary Effects', 'orgStudyIdInfo': {'id': '2019-06197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'The intervention consists of a self-guided digital tool to guide participants with chronic insomnia through sleep restriction and stimulus control procedures.', 'interventionNames': ['Behavioral: Digital self-guided CBT-i']}], 'interventions': [{'name': 'Digital self-guided CBT-i', 'type': 'BEHAVIORAL', 'otherNames': ['Self-care digital tool'], 'description': 'A brief version of CBT-i consisting of brief psychoeducation, and the core components sleep restricion and stimulus control, where sleep restriction is based on a simplified sleep diary.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Susanna Jernelöv', 'investigatorAffiliation': 'Karolinska Institutet'}}}}