Viewing Study NCT02068261


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Study NCT ID: NCT02068261
Status: UNKNOWN
Last Update Posted: 2015-10-23
First Post: 2014-02-19
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Working Memory Training in Adults With Substance Abuse and Executive Function Deficits.
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000987', 'term': 'Antisocial Personality Disorder'}, {'id': 'D004410', 'term': 'Dyslexia'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-22', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in substance abuse measured with Substance abuse scales in Adult Self Report (ASR; ASEBA).', 'timeFrame': 'Baseline and at 25 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Adult Self Report (ASR; ASEBA) Attention problems scale.', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in Adult Self Report (ASR; ASEBA) Internalizing index.', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in Adult Self Report (ASR; ASEBA) Externalizing index.', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in Adult Self Report (ASR; ASEBA) Adaptive functioning scales.', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in Executive functioning measured with Behavior Rating Inventory of Executive Function-Adult (BRIEF-A).', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in verbal working memory measured with performance on Digit span.', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in visual working memory measured with performance on Span board.', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in focused attention measured with performance on Conners Continuous Performance Test-II (CCPT-II).', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in vigilance measured with performance on Conners Continuous Performance Test-II (CCPT-II).', 'timeFrame': 'Baseline and at 25 weeks'}, {'measure': 'Change from baseline in reading speed measured with performance on Reading speed in Diagnostic Reading and Writing Test (DLS; Swedish version).', 'timeFrame': 'Baseline and at 25 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Substance Abuse', 'Executive Dysfunction', 'Anxiety', 'Depression', 'Antisocial Personality', 'Reading Disabilities']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of a computerized working memory training program on substance abuse, psychosocial functioning, cognitive performance and psychiatric problems in adults with substance abuse and attention problems.', 'detailedDescription': 'The primary aim of this study is to examine the effects of 5 weeks of computerized working memory training on substance abuse. Secondary aims are to explore whether effects are mediated by changes in executive functions and/or moderated by personality. Also, effects on measures of psychosocial functioning, depression, anxiety and attention will be explored. Follow-up assessment will be conducted at 6 months post training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment seeking adults with substance abuse and executive function deficits.\n\nExclusion Criteria:\n\n* Acute intoxication or abstinence symptoms of any substance.\n* Psychosis.'}, 'identificationModule': {'nctId': 'NCT02068261', 'briefTitle': 'Working Memory Training in Adults With Substance Abuse and Executive Function Deficits.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Örebro Läns Landsting'}, 'officialTitle': 'Computerized Working Memory Training in Adults With Substance Abuse and Executive Function Deficits: A Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'RA02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cogmed working memory training', 'description': '30-40 minutes of Cogmed computerized working memory training 3-5 days a week for 5-8 weeks. Every training session consists of a set of visual- and verbal working memory tasks that are trained on during the session.', 'interventionNames': ['Behavioral: Computerized Cogmed working memory training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment. After a 8 week period participants in this arm well be offered Cogmed working memory training.', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'Computerized Cogmed working memory training', 'type': 'BEHAVIORAL', 'description': 'Computerized working memory training with Cogmed QM software. The QM software consists of a set of verbal and visual working memory tasks which is trained for 25-40 minutes each session.', 'armGroupLabels': ['Cogmed working memory training']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment.', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701 16', 'city': 'Örebro', 'state': 'Örebro County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Rickard Ahlberg, doctoral student', 'role': 'CONTACT', 'email': 'rickard.ahlberg@orebroll.se'}, {'name': 'Lars Kjellin, docent', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Psychiatric Research Centre', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'centralContacts': [{'name': 'Rickard Ahlberg, doctoral student', 'role': 'CONTACT', 'email': 'rickard.ahlberg@orebroll.se'}, {'name': 'Kurt Skårberg, MD', 'role': 'CONTACT', 'email': 'kurt.skarberg@orebroll.se'}], 'overallOfficials': [{'name': 'Lars Kjellin, Docent', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Örebro Läns Landsting'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro Läns Landsting', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical psychologist, doctoral student.', 'investigatorFullName': 'Rickard Ahlberg', 'investigatorAffiliation': 'Örebro Läns Landsting'}}}}