Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT02808702
Status:
COMPLETED
Last Update Posted:
2022-10-31
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Correlates of Self-Focused Processing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D057215', 'term': 'Body Dysmorphic Disorders'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline clinical symptoms at 12 weeks', 'timeFrame': 'Baseline and 12 weeks from baseline', 'description': 'Evidence of symptom improvement as determined by clinician-administered assessment of body dysmorphic and socially anxious symptoms'}, {'measure': 'Neural activation in the default mode network', 'timeFrame': 'Baseline and 12 weeks later', 'description': 'Difference in regional brain activation in the default mode network in the Self vs. Other contrast (specifically in the medial prefrontal cortex, temporoparietal junction, posterior cingulate) during fMRI activation paradigm'}, {'measure': 'Resting state functional connectivity within the default mode network', 'timeFrame': 'Baseline and 12 weeks later', 'description': 'Functional connectivity within the default mode network during resting state scan'}, {'measure': 'Response latencies during Self vs. Other conditions', 'timeFrame': 'Baseline and 12 weeks later', 'description': 'Difference in average response latencies (in ms) during Self and Other conditions of a self-referential processing task'}], 'secondaryOutcomes': [{'measure': 'Word valence during Self vs. Other conditions', 'timeFrame': 'Baseline and 12 weeks later', 'description': 'Number of positive and negative words endorsed during Self and Other task conditions'}, {'measure': 'Structural connectivity within the default mode network', 'timeFrame': 'Baseline and 12 weeks later', 'description': 'White matter connectivity within the default mode network during DTI scan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Attention', 'Cognitive behavioral therapy', 'Neuroimaging'], 'conditions': ['Social Phobia', 'Body Dysmorphic Disorder']}, 'referencesModule': {'references': [{'pmid': '38266332', 'type': 'DERIVED', 'citation': 'Fang A, Baran B, Feusner JD, Phan KL, Beatty CC, Crane J, Jacoby RJ, Manoach DS, Wilhelm S. Self-focused brain predictors of cognitive behavioral therapy response in a transdiagnostic sample. J Psychiatr Res. 2024 Mar;171:108-115. doi: 10.1016/j.jpsychires.2024.01.018. Epub 2024 Jan 16.'}, {'pmid': '37693433', 'type': 'DERIVED', 'citation': 'Fang A, Baran B, Feusner JD, Phan KL, Beatty CC, Crane J, Jacoby RJ, Manoach DS, Wilhelm S. Self-Focused Brain Predictors of Cognitive Behavioral Therapy Response in a Transdiagnostic Sample. medRxiv [Preprint]. 2023 Sep 2:2023.08.30.23294878. doi: 10.1101/2023.08.30.23294878.'}, {'pmid': '34875086', 'type': 'DERIVED', 'citation': 'Fang A, Baran B, Beatty CC, Mosley J, Feusner JD, Phan KL, Wilhelm S, Manoach DS. Maladaptive self-focused attention and default mode network connectivity: a transdiagnostic investigation across social anxiety and body dysmorphic disorders. Soc Cogn Affect Neurosci. 2022 Jul 2;17(7):645-654. doi: 10.1093/scan/nsab130.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether neuroimaging-based markers of maladaptive self-focused processing are better predictors of treatment response to cognitive-behavioral therapy than behavioral markers.', 'detailedDescription': 'First, the investigators propose to identify the neural correlates of self-focused processing. The investigators will assess baseline resting state connectivity within the default network, as well as regional brain activation using a well-validated event-related fMRI task that manipulates self-focused processing in patients with body dysmorphic and socially anxious symptoms, compared to healthy controls. This clinical sample was selected because such patients display heightened self-focused attention, and sampling individuals across these symptom dimensions will ensure greater variability on this dimension of maladaptive self-focused processing. Second, the investigators will examine the neural correlates of self-focused processing as a predictor of treatment response. Neuroimaging data will be acquired from patients with body dysmorphic and socially anxious symptoms during two scan sessions, before and after 12 weeks of individual cognitive behavioral therapy, and compared with healthy controls scanned twice at a 12 week interval. Finally, the investigators will compare the prediction of treatment response between neural measures and behavioral measures of self-focused processing. The investigators will assess the behavioral correlates of self-focused processing using a self-reference effect paradigm, and assess their relation to treatment response. If the investigators hypotheses are borne out, the investigators will have new targets for treatment, a method to identify promising candidates for treatment, and sensitive surrogate markers of treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, age 18-45\n* For patients: treatment-seeking individuals presenting with at least moderate levels of social anxiety/body dysmorphic symptoms, and a score of at least 1 SD above the mean on the public self-consciousness scale of the Self-Consciousness Scale- Revised\n* For healthy controls only: no current or lifetime history of psychiatric disorders, and score of below 1 SD of mean on the SCS-R\n* Right-handed, as determined by the Handedness Inventory\n* Fluent in English, and willing to provide informed consent\n\nExclusion Criteria:\n\n* Positive MR screen\n* History of head injury, neurological disorder, or neurosurgical procedure\n* Active suicidal or homicidal ideation\n* Current or past manic/hypomanic episode or psychotic symptoms\n* Active alcohol and substance dependence (as assessed by the SCID-5-RV\n* Current use of psychotropic medications, except antidepressants taken at a stable dose for 2 weeks, to maximize generalizability of sample\n* Current CBT and/or formal mindfulness/meditation training\n* History of more than 10 sessions of CBT and formal mindfulness/meditation training'}, 'identificationModule': {'nctId': 'NCT02808702', 'briefTitle': 'Brain Correlates of Self-Focused Processing', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Brain Correlates of Self-Focused Processing as a Biomarker of Treatment Response', 'orgStudyIdInfo': {'id': '1K23MH109593-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23MH109593-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive-behavioral therapy', 'description': 'Twelve weekly sessions of individual cognitive-behavioral therapy', 'interventionNames': ['Behavioral: Cognitive-behavioral therapy']}], 'interventions': [{'name': 'Cognitive-behavioral therapy', 'type': 'BEHAVIORAL', 'description': 'Twelve weekly sessions of individual cognitive-behavioral therapy', 'armGroupLabels': ['Cognitive-behavioral therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Angela Fang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychology', 'investigatorFullName': 'Angela Fang', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}