Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT05384158
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2022-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Valuation in Depressed Mood, Anhedonia, and Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D059445', 'term': 'Anhedonia'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 252}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-05-17', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "change in proportion correct on the 'N-arm bandit learning task'", 'timeFrame': 'study entrance to study exit, an average of 12 weeks', 'description': "change in proportion correct on 'N-arm bandit reinforcement learning task' from study entrance to study exit"}], 'secondaryOutcomes': [{'measure': 'change in depression symptoms (Beck Depression Inventory)', 'timeFrame': 'study entrance to exit, an average of 12 weeks', 'description': 'change in depression symptoms from study entrance to study exit'}, {'measure': 'change in anxiety symptoms (anxiety subscale; Mood and Anxiety Symptom Questionnaire)', 'timeFrame': 'study entrance to exit, an average of 12 weeks', 'description': 'change in anxiety symptoms from study entrance to study exit'}, {'measure': 'change in anhedonia symptoms (anhedonia subscale; Mood and Anxiety Symptom Questionnaire)', 'timeFrame': 'study entrance to exit, an average of 12 weeks', 'description': 'change in anhedonia symptoms from study entrance to study exit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depression', 'anxiety', 'anhedonia'], 'conditions': ['Neurobehavioral Components of Reward and Loss Valuation']}, 'descriptionModule': {'briefSummary': 'This study examines how people respond to rewards and losses, and the extent to which these responses are linked or distinct among people experiencing depressed mood, anhedonia, and/or anxiety.', 'detailedDescription': 'This study tests relationships among neural and behavioral valuation mechanisms, and how these mechanisms change (or not) over time, with task instructions, and following cognitive behavior therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mood, anxiety, or anhedonia symptoms that affect functioning; fluent in English; able to see computer display; able to perform simple computer games.\n\nExclusion Criteria:\n\n* history of seizure disorder, stroke, or head injury with more than 10 minutes of unconsciousness; hormone disorder; electroconvulsive therapy within 5 years; history of chemotherapy for cancer; current pregnancy; contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT05384158', 'briefTitle': 'Valuation in Depressed Mood, Anhedonia, and Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Polytechnic Institute and State University'}, 'officialTitle': 'Evaluating Overlap and Distinctiveness in Neurocomputational Loss and Reward Elements of the RDoC Matrix', 'orgStudyIdInfo': {'id': 'RDOC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive behavioral therapy', 'description': 'cognitive behavioral therapy for depression, anxiety, and/or anhedonia', 'interventionNames': ['Behavioral: cognitive behavioral therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valuation with instruction', 'description': 'repeat laboratory sessions of a reward/loss learning computer game with specific instructions', 'interventionNames': ['Behavioral: valuation with instruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valuation without instruction', 'description': 'repeat laboratory sessions of a reward/loss learning computer game without specific instructions', 'interventionNames': ['Behavioral: valuation without instruction']}], 'interventions': [{'name': 'cognitive behavioral therapy', 'type': 'BEHAVIORAL', 'description': 'cognitive behavioral therapy', 'armGroupLabels': ['Cognitive behavioral therapy']}, {'name': 'valuation with instruction', 'type': 'BEHAVIORAL', 'description': 'repeat laboratory sessions of computerized learning game', 'armGroupLabels': ['Valuation with instruction']}, {'name': 'valuation without instruction', 'type': 'BEHAVIORAL', 'description': 'repeat laboratory sessions of computerized learning game', 'armGroupLabels': ['Valuation without instruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pearl Chiu, PhD', 'role': 'CONTACT', 'email': 'chiup@vtc.vt.edu', 'phone': '540-526-2032'}], 'facility': 'Fralin Biomedical Research Institute at Virginia Tech Carilion', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Polytechnic Institute and State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pearl Chiu', 'investigatorAffiliation': 'Virginia Polytechnic Institute and State University'}}}}