Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 12:01 PM
Study NCT ID:
NCT00965705
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2009-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stepped Care Treatment for Binge-Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2009-08-25', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month', 'timeFrame': 'Up to 12 months after randomization', 'description': 'Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Binge Eating Disorder', 'overeating', 'binge eating', 'women', 'overweight', 'compulsive overeating'], 'conditions': ['Binge Eating Disorder']}, 'referencesModule': {'references': [{'pmid': '27852348', 'type': 'RESULT', 'citation': 'Chen EY, Cacioppo J, Fettich K, Gallop R, McCloskey MS, Olino T, Zeffiro TA. An adaptive randomized trial of dialectical behavior therapy and cognitive behavior therapy for binge-eating. Psychol Med. 2017 Mar;47(4):703-717. doi: 10.1017/S0033291716002543. Epub 2016 Nov 17.'}, {'pmid': '24235091', 'type': 'RESULT', 'citation': 'Southward MW, Christensen KA, Fettich KC, Weissman J, Berona J, Chen EY. Loneliness mediates the relationship between emotion dysregulation and bulimia nervosa/binge eating disorder psychopathology in a clinical sample. Eat Weight Disord. 2014 Dec;19(4):509-13. doi: 10.1007/s40519-013-0083-2.'}], 'seeAlsoLinks': [{'url': 'http://sites.temple.edu/tedp', 'label': 'Temple University Eating Disorders (TED) Website'}]}, 'descriptionModule': {'briefSummary': 'Temple University is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder.\n\nBinge-Eating Disorder is a significant public health problem for women. Despite this, there is limited research on how best to treat this disorder at varying levels of severity. The purpose of this NIMH-funded study is to enroll individuals in a brief form of cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been adapted for women living with binge-eating disorder and are free of charge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female, 18 years to 60 years\n* Meets DSM-IV criteria for Binge Eating Disorder\n* Resides within commuting distance\n* Consents to research protocol, i.e.\n* 18-24 months in assessment and treatment\n* willing to be part of a biological assessment/physiological assessment\n* have to be prepared that they will receive a brief individual treatment and if this does not work for them, that they will receive more intensive treatment including both group and individual treatment.\n* agreement not to see other health professionals unless recommended\n* seeing their own Primary care Physician/Nurse Practitioner for medical screening prior to study (i.e., before being allocated a guided self-help therapist)\n* payment for their own medical assessment, monitoring, and medication if needed\n\nExclusion Criteria:\n\n* Anorexia nervosa\n* Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS, or Bipolar Mood Disorder\n* Needs priority treatment for other debilitating conditions, e.g. current substance dependence requiring inpatient detox\n* chronic absence of shelter\n* IQ less than 70\n* Impending jail/prison, court order to treatment, court order to treatment or to jail, or agency order to treatment or to loss of child custody (due to consequent inability to freely drop-out of treatment)\n* Is pregnant, plans to become pregnant during treatment, or becomes pregnant before random assignment to study condition\n* Medical instability\n* Has had or is seeking Gastric bypass surgery\n* On anti-seizure medication, beta-blockers, asthma medication, medication for heart disease, or any other medication that affects appetite or weight\n* Psychotropics are acceptable if the doses are stable for at least 3 months prior to screening'}, 'identificationModule': {'nctId': 'NCT00965705', 'briefTitle': 'Stepped Care Treatment for Binge-Eating', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Dialectical Behavior Therapy for Early Non-Responders to CBT', 'orgStudyIdInfo': {'id': '20472'}, 'secondaryIdInfos': [{'id': 'K23MH081030-01', 'link': 'https://reporter.nih.gov/quickSearch/K23MH081030-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Guided Self Help', 'interventionNames': ['Behavioral: Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dialectical Behavioral Therapy', 'interventionNames': ['Behavioral: Therapy']}], 'interventions': [{'name': 'Therapy', 'type': 'BEHAVIORAL', 'description': 'Individual Therapy and Group Therapy', 'armGroupLabels': ['Cognitive Behavioral Therapy', 'Dialectical Behavioral Therapy', 'Guided Self Help']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19122', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Eunice Y Chen, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Eunice Chen', 'investigatorAffiliation': 'Temple University'}}}}