Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 7:47 AM
Study NCT ID:
NCT03852966
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Better Sleep in Psychiatric Care - ADHD Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pragmatic, within-group pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-10', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Change from baseline to 10 weeks', 'description': '7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Change from baseline to 24 weeks', 'description': '7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Adult ADHD Self-Report Scale (ASRS)', 'timeFrame': 'Change from baseline to 10 weeks', 'description': '18-item self-reported measure of inattention and hyperactivity symptoms. Total score 0-72. Subscale inattention/hyperactivity 0-36 points per scale. Higher scores represents more severe symptoms (worse outcome).'}, {'measure': 'Adult ADHD Self-Report Scale (ASRS)', 'timeFrame': 'Change from baseline to 24 weeks', 'description': '18-item self-reported measure of inattention and hyperactivity symptoms. Total score 0-72. Subscale inattention/hyperactivity 0-36 points per scale. Higher scores represents more severe symptoms (worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Disorder', 'Sleep Initiation and Maintenance Disorders', 'Sleep Wake Disorders']}, 'referencesModule': {'references': [{'pmid': '31340804', 'type': 'RESULT', 'citation': 'Jernelov S, Larsson Y, Llenas M, Nasri B, Kaldo V. Effects and clinical feasibility of a behavioral treatment for sleep problems in adult attention deficit hyperactivity disorder (ADHD): a pragmatic within-group pilot evaluation. BMC Psychiatry. 2019 Jul 24;19(1):226. doi: 10.1186/s12888-019-2216-2.'}]}, 'descriptionModule': {'briefSummary': 'Comorbidities, including sleep problems, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD and sleep problems.\n\nThe purpose of this study was to investigate if patients at a specialist clinic for ADHD benefit from a group delivered CBT-i treatment; whether insomnia severity improves following this treatment.\n\nThis pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult ADHD.\n\nAs an adjunct to care-as-usual at the clinic, a CBT-i-based group treatment targeting sleep problems prevalent in the ADHD-population, designed for patients with executive difficulties, was offered as 10 weekly 90-minute group sessions and scheduled telephone support.\n\nAll outcome measures were subjectively reported by participants. Data analyzed with dependent t-tests according to intent-to-treat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being a patient at the clinic (i.e. having a diagnosis of AD(H)D)\n* self-reported sleep problems\n* returning pre-treatment questionnaires and signed consent form\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03852966', 'acronym': 'BeSiP-ADHD', 'briefTitle': 'Better Sleep in Psychiatric Care - ADHD Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Better Sleep in Psychiatric Care - ADHD. A Pragmatic Within-group Pilot Study to Develop and Evaluate Effects and Feasibility of a CBT-based Manual for Treating Sleep Problems in Adult Patients With ADHD', 'orgStudyIdInfo': {'id': '2015/2078-31/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-i/ADHD', 'description': 'Behavioral treatment for sleep problems in ADHD', 'interventionNames': ['Behavioral: CBT-i/ADHD']}], 'interventions': [{'name': 'CBT-i/ADHD', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD', 'armGroupLabels': ['CBT-i/ADHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113 21', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of ADHD, Northern Stockholm Psychiatry', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Susanna Jernelöv, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Susanna Jernelöv', 'investigatorAffiliation': 'Karolinska Institutet'}}}}