Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-03 @ 2:30 AM
Study NCT ID:
NCT01906268
Status:
UNKNOWN
Last Update Posted:
2014-07-21
First Post:
2013-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010698', 'term': 'Phobic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2013-07-23', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dot-probe and Executive Function Measures', 'timeFrame': 'Endpoint and 3-months follow-up', 'description': 'Change in bias in attention orienting and executive function measures from baseline to endpoint and 3-months follow-up'}], 'primaryOutcomes': [{'measure': 'Overall Anxiety Severity and Impairment Scale (OASIS)', 'timeFrame': 'Endpoint and 3-months follow-up', 'description': 'Disorder non-specific primary outcome:\n\nScore change on OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to endpoint and 3-months follow-up'}, {'measure': 'Panic Disorder Severity Scale (PDSS), Generalized Anxiety Disorder 7-item Scale (GAD-7) or Liebowitz Social Anxiety Scale (LSAS)', 'timeFrame': 'Endpoint and 3-months follow up', 'description': 'Disorder-specific primary outcome:\n\nFor patients with Panic Disorder - change from baseline to endpoint and 3 months follow-up in the PDSS\n\nFor patients with Generalized Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the GAD-7\n\nFor patients with Social Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the LSAS'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'Endpoint and 3-months follow-up', 'description': 'Score change on BDI from baseline to endpoint and 3-months follow up'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Endpoint and 3-months follow-up', 'description': 'Score change on BAI from baseline to endpoint and 3-months follow up'}, {'measure': 'DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]', 'timeFrame': 'Endpoint and 3-months follow-up', 'description': 'Score change on Cross-D from baseline to endpoint and 3-months follow up'}, {'measure': 'Profile of Mood States (POMS)', 'timeFrame': 'Endpoint and 3-months follow-up', 'description': 'Score Change on POMS from baseline to endpoint and 3-months follow up.'}, {'measure': 'Clinical Global Impression(CGI)', 'timeFrame': 'Endpoint and 3-months follow-up', 'description': 'Dichotomous outcome: percentage of patients with a score of 2 or less at the endpoint and 3-months follow-up evaluations'}]}, 'conditionsModule': {'keywords': ['Generalized Anxiety Disorder', 'Social Anxiety Disorder', 'Panic Disorder', 'Antidepressants Resistant', 'Attentional Bias Modification Treatment (ABMT)', 'Attentional Retraining', 'Adjuvant Therapy'], 'conditions': ['Generalized Anxiety Disorder', 'Social Anxiety Disorder', 'Panic Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant to antidepressants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of Generalized Anxiety Disorder, Panic Disorder or Social Anxiety Disorder according to the International Neuropsychiatric Interview psychiatric interview (M.I.N.I.)\n* Current treatment for the anxiety disorder with antidepressants with an appropriate dose for at least 8 weeks;\n* Score on OASIS (Overall Anxiety Severity and Impairment Scale)equal or greater than 8\n\nExclusion Criteria:\n\n* Other psychiatric disorder that causes more impairment and suffering than generalized anxiety disorder, panic disorder or social anxiety disorder in the clinical evaluation\n* Current Cognitive Behavior Therapy\n* Marked intellectual disability (clinically evident)\n* Suicidal ideation or suicide plan at the time of assessment(M.I.N.I.)\n* Psychotic disorder (M.I.N.I.)\n* Bipolar disorder type I (M.I.N.I.)\n* Abuse / Dependence substances (M.I.N.I.)'}, 'identificationModule': {'nctId': 'NCT01906268', 'briefTitle': 'Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '13-0338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAU + ABMT active', 'description': 'Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor\n\nAttention Bias Modification Treatment (ABMT) - active', 'interventionNames': ['Other: Attentional Bias Modification Treatment (ABMT) - Active']}, {'type': 'SHAM_COMPARATOR', 'label': 'TAU + AMBT placebo', 'description': 'Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor\n\nAttention Bias Modification Treatment (ABMT) - placebo (sham)', 'interventionNames': ['Other: Attentional Bias Modification Treatment - Placebo']}], 'interventions': [{'name': 'Attentional Bias Modification Treatment (ABMT) - Active', 'type': 'OTHER', 'description': 'The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (\\< or \\>) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.\n\nNumber of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)', 'armGroupLabels': ['TAU + ABMT active']}, {'name': 'Attentional Bias Modification Treatment - Placebo', 'type': 'OTHER', 'description': 'The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.\n\nNumber of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)', 'armGroupLabels': ['TAU + AMBT placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90040-371', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90040-371', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Rachel Montagner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giovanni A Salum Junior', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juliana L Muller', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Clarissa Trentini', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Rachel Montagner, MD', 'role': 'CONTACT', 'email': 'rachelmontagner@hotmail.com', 'phone': '+55 51 3359 8983'}], 'overallOfficials': [{'name': 'Gisele G Manfro, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}