Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT04258618
Status:
COMPLETED
Last Update Posted:
2024-10-24
First Post:
2020-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy for Insomnia with RTMS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}, {'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Reported Unanticipated Adverse Events', 'timeFrame': 'Baseline through post intervention (6 weeks)', 'description': 'Tolerability of CBT-I with TMS determined by patient reported adverse event as assessed by red cap form'}, {'measure': 'Percentage of patients completing CBT-I program', 'timeFrame': 'Determined post intervention (6 weeks)', 'description': 'Feasibility of implementation of CBT-I as assessed by completion percentage of patients enrolled.'}], 'secondaryOutcomes': [{'measure': 'Change in Epworth Sleepiness Scale', 'timeFrame': 'Baseline and post intervention (6 weeks)', 'description': 'Assessing pre and post TMS treatment changes of ESS in TMS + CBT-I group vs no CBT-I group. The scale is scored 0-24 assessing degree of sleepiness. Cutoff scores are as follows: 0-7:It is unlikely that you are abnormally sleepy. 8-9:You have an average amount of daytime sleepiness; 10-15:You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention;16-24:You are excessively sleepy and should consider seeking medical attention. This scale is often used clinically for obstructive sleep apnea, but can be useful to assess daytime impact of insomnia.'}, {'measure': 'Change in Insomnia Severity Index Scale', 'timeFrame': 'Baseline through post intervention (6 weeks)', 'description': 'Assessing pre and post TMS treatment changes of ISI in TMS + CBT-I group vs no CBT-I group. This scale is scored 0-28 and is used to assess severity of insomnia with cutoff scores as follows: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia;15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe).'}, {'measure': 'Change in Patient Health Questionnaire - 9', 'timeFrame': 'Baseline through post intervention (6 weeks)', 'description': 'Assessing pre and post TMS treatment changes of PHQ-9 in TMS + CBT-I group vs no CBT-I group. This scale is used to assess depression severity. Cutoff scores are as follows: 0-4: Minimal or none; 5-9: Mild; 10-14: Moderate; 15-19: Moderately severe; 20-27: Severe.'}, {'measure': 'Change in Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline and post intervention (6 weeks)', 'description': 'Assessing pre and post TMS treatment changes of PSQI in TMS + CBT-I group vs no CBT-I group. This scale is a 9-item questionnaire assessing sleep quality. The score is determined by adding up 7 components, with a score of 5 or greater being considered poor sleep.'}, {'measure': 'Change in Hamilton Rating Scale for Depression 17', 'timeFrame': 'Baseline and post intervention (6 weeks)', 'description': 'Assessing pre and post TMS treatment changes of HRSD 17 in TMS + CBT-I group vs no CBT-I group. This is a 17- item scale assessing severity of depression symptoms and is scored out of 58 (8 questions scored out of 5 and 9 questions scored out of 2), with 0-7 considered normal and \\> 20 considered at least moderate severity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Insomnia']}, 'referencesModule': {'references': [{'pmid': '34563744', 'type': 'DERIVED', 'citation': 'Norred MA, Haselden LC, Sahlem GL, Wilkerson AK, Short EB, McTeague LM, George MS. TMS and CBT-I for comorbid depression and insomnia. Exploring feasibility and tolerability of transcranial magnetic stimulation (TMS) and cognitive behavioral therapy for insomnia (CBT-I) for comorbid major depressive disorder and insomnia during the COVID-19 pandemic. Brain Stimul. 2021 Nov-Dec;14(6):1508-1510. doi: 10.1016/j.brs.2021.09.007. Epub 2021 Sep 23. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Depression and insomnia occur together in a substantial number of patients. Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. A form of cognitive behavioral therapy (CBT) has been developed that specifically helps with insomnia (CBT-I). The study team will give CBT-I to patients who are being treated with TMS for depression, who also have insomnia, to determine if it helps insomnia symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-85 years old\n* Patients starting rTMS treatment for MDD\n* Co-morbid insomnia as determined by meeting the following criteria: (a) Requiring more than 30 minutes to fall asleep at the beginning of the night or more than 30 minutes of time awake after initially falling asleep for at least 3 nights per week for at least 3 months - - An insomnia severity index score of 15 or more\n* Manifested sleep disturbances or associated daytime symptoms causing significant distress or impairment in social, occupational or other areas of functioning\n* Reliable access to a computer with internet access.\n\nExclusion Criteria:\n\n* Obligation to an irregular sleep schedule that prevents the adoption of intervention strategies such as shift workers\n* Participants who have received or are receiving CBT-I targeting insomnia in the past, or those who have initiated a new sedative medication, or sedating antidepressant within 2-weeks preceding enrollment\n* Comorbid psychiatric disorders, including bipolar disorder, psychotic disorders or depression with psychotic features\n* Presence of another untreated sleep disorder such as obstructive sleep apne\n* Pregnancy\n* Active substance use disorder within the past 3 months\n* Use of medications that reduce the seizure threshold including Buproprion, stimulants or augmenting thyroid medications (for those without history of hypothyroid)'}, 'identificationModule': {'nctId': 'NCT04258618', 'briefTitle': 'Cognitive Behavioral Therapy for Insomnia with RTMS', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'CBT-I Targeting Co-morbid Insomnia in Patients Receiving RTMS for Treatment-Resistant Major Depressive Disorder', 'orgStudyIdInfo': {'id': '00089725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS', 'interventionNames': ['Behavioral: CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS']}, {'type': 'OTHER', 'label': 'rTMS (repetitive Transcranial Magnetic Stimulation)', 'description': 'Subjects will be getting Transcranial Magnetic Stimulation as part of their standard of care.', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioral Therapy for insomnia (CBT-I) with rTMS (repetitive Transcranial Magnetic Stimulation) will be performed as part of this study by the PI. This includes weekly, one hour sessions addressing sleep for 6 weeks.', 'armGroupLabels': ['CBT-I (Cognitive Behavioral Therapy for Insomnia) with TMS']}, {'name': 'Repetitive Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': 'Participants in this study will be undergoing repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder as part of their clinical treatment. This involves magnetic stimulation with specific settings to a specific region of the brain to help treat depression. Treatment time ranges, but is around 30 minutes per session and occurs 5 days a week for 6 weeks.', 'armGroupLabels': ['rTMS (repetitive Transcranial Magnetic Stimulation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Michael Norred, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Drug Abuse Research Training Program', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}