Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-24 @ 12:55 AM
Study NCT ID:
NCT03971903
Status:
COMPLETED
Last Update Posted:
2019-06-03
First Post:
2018-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention Bias Modification Treatment for Young Adults With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Particpants are assigned to active ABM treatment or placebo training'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-31', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of attention bias score', 'timeFrame': 'pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )', 'description': 'Attention bias score changes tested by a typical dot-probe task'}, {'measure': 'Changes of depressive symptoms', 'timeFrame': 'pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )', 'description': 'Depression symptoms tested by clinicians using Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)'}, {'measure': 'Changes of severity of depression', 'timeFrame': 'pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )', 'description': 'The severity of depression tested by clinicians using the 17-Item Hamilton Depression Rating Scale (HAM-D)'}], 'secondaryOutcomes': [{'measure': 'Changes of self-reported depressive symptoms', 'timeFrame': 'pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )', 'description': 'Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II), and trait anxiety assessed by State Trait Anxiety Inventory-Trait(STAI-T), rumination assessed by Rumination Response Scale(RRS).'}, {'measure': 'Changes of self-reported trait anxiety', 'timeFrame': 'pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )', 'description': 'self-reported trait anxiety assessed by State Trait Anxiety Inventory-Trait(STAI-T)'}, {'measure': 'Changes of self-reported rumination', 'timeFrame': 'pre-training, post-training(4 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month(booster pre-training),4-month(booster post-training),5-month,6-month,12-month after post-training )', 'description': 'Self-reported rumination assessed by Rumination Response Scale(RRS).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Attenion bias modification, major depression, treatment'], 'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'references': [{'pmid': '25245928', 'type': 'BACKGROUND', 'citation': 'Yang W, Ding Z, Dai T, Peng F, Zhang JX. Attention Bias Modification training in individuals with depressive symptoms: A randomized controlled trial. J Behav Ther Exp Psychiatry. 2015 Dec;49(Pt A):101-11. doi: 10.1016/j.jbtep.2014.08.005. Epub 2014 Sep 8.'}, {'pmid': '26903254', 'type': 'RESULT', 'citation': 'Yang W, Zhang JX, Ding Z, Xiao L. Attention Bias Modification Treatment for Adolescents With Major Depression: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2016 Mar;55(3):208-18.e2. doi: 10.1016/j.jaac.2015.12.005. Epub 2015 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators test whether a 4-week 12-session attention bias modification treatment (ABMT) could reduce depressive symptoms relative to placebo controls in young adults with major depressive disorder at post-training and 3-month follow-ups. Meanwhile, the investigators also test whether a 2-week 4-session ABMT booster training for every three months could reduce residual depressive symptoms and recurrences relative to placebo controls for 1-year follow-up', 'detailedDescription': 'Attention Bias Modification Training was a modified dot-probe task, in which 90% of the targets appeared at the neutral word position and 10% at the sad word position. The placebo training procedure is a classic dot-probe task in which the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions. The investigators assess attention bias scores, depressive symptoms, trait anxiety, rumination and self-report attention control ability at 1-week, 2-week, 4-week,7-week,3-month,4-month, 5-month, 6-month and 12-month follow-ups after training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '16 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of definite and probable MDD (i.e., at least 1 core symptom plus 3 further depressive symptoms present for at least 2 weeks) diagnoses\n\nExclusion Criteria:\n\n* a diagnosis of bipolar disorder, schizophrenia, or mood disorder due to a general medical condition or substance-induced mood disorder; and any concurrent treatment (i.e., psychotherapy and/or pharmacotherapy).'}, 'identificationModule': {'nctId': 'NCT03971903', 'briefTitle': 'Attention Bias Modification Treatment for Young Adults With Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Normal University'}, 'officialTitle': 'Department of Psychology, Hunan Normal University', 'orgStudyIdInfo': {'id': 'BBA130016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attention bias modification treatment', 'description': '12-session of ABMT', 'interventionNames': ['Behavioral: Attention bias modification']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo controls', 'description': '12-session of placebo(i.e.,sham) training', 'interventionNames': ['Behavioral: Attention bias modification']}], 'interventions': [{'name': 'Attention bias modification', 'type': 'BEHAVIORAL', 'description': 'The ABM training task was a variation of the computerized visual dot-probe task. During the training, each session includes 54 neutral-sad word pairs presenting 6 times (6 × 54=324 trials) during 20-minute. Participants received 12 sessions over 4 weeks (1 session every other day). In the active ABMT, 90% of the probes appeared at the neutral position and 10% at the sad position. At the placebo ABMT, 50% of the probes appeared at the neutral position and 50% at the sad position.', 'armGroupLabels': ['Attention bias modification treatment', 'Placebo controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410081', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Department of Psychology, Hunan Normal University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Wenhui Yang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Normal University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After 2020 and forever', 'ipdSharing': 'YES', 'description': 'After completion, all the data can be shared', 'accessCriteria': 'Just for research'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Psychology', 'investigatorFullName': 'Wenhui Yang', 'investigatorAffiliation': 'Hunan Normal University'}}}}