protocolSection identificationModule nctId: NCT06373718, orgStudyIdInfo id: IRB-74553, briefTitle: A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target., conditionsModule conditions: Insomnia, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Enrolled participants will be randomized into either the Immediate Treatment group, or the Monitored Control group. Both study groups will receive CBT-I., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy for Insomnia, outcomesModule primaryOutcomes measure: Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging, primaryOutcomes measure: Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging, primaryOutcomes measure: Change in Beck Depression Inventory, primaryOutcomes measure: Change in PSG Sleep Efficiency, secondaryOutcomes measure: Change in Columbia Suicide Severity Rating Scale, secondaryOutcomes measure: Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in Actigraph Number of Arousals as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity, secondaryOutcomes measure: Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in PSG Number of Arousals as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture, secondaryOutcomes measure: Change in Sleep Physiology measured by PSG, secondaryOutcomes measure: Change in Insomnia Severity Index (ISI) Scale Score, secondaryOutcomes measure: Change in 36-Item Short Form Survey (SF-36) Score, secondaryOutcomes measure: Change in Beck Anxiety Inventory, secondaryOutcomes measure: Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Stanford University, city: Palo Alto, state: California, zip: 94304, country: United States, contacts name: Pandora Lam, role: CONTACT, phone: 650-497-5130, email: pal217@stanford.edu, contacts name: Andrea Goldstein-Piekarski, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False