Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-12 @ 10:06 AM
Study NCT ID:
NCT00879151
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2009-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Treatment for Adolescents With Bulimia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002032', 'term': 'Bulimia'}], 'ancestors': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2009-04-07', 'studyFirstSubmitQcDate': '2009-04-08', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binge and purge frequency as assessed by the Eating Disorder Examination (EDE)', 'timeFrame': 'End of Treatment'}], 'secondaryOutcomes': [{'measure': 'Changes in the subscale scores of the EDE', 'timeFrame': 'End of Treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bulimia']}, 'referencesModule': {'references': [{'pmid': '30734406', 'type': 'DERIVED', 'citation': 'Gorrell S, Kinasz K, Hail L, Bruett L, Forsberg S, Lock J, Le Grange D. Rituals and preoccupations associated with bulimia nervosa in adolescents: Does motivation to change matter? Eur Eat Disord Rev. 2019 May;27(3):323-328. doi: 10.1002/erv.2664. Epub 2019 Feb 7.'}, {'pmid': '29446174', 'type': 'DERIVED', 'citation': 'Valenzuela F, Lock J, Le Grange D, Bohon C. Comorbid depressive symptoms and self-esteem improve after either cognitive-behavioural therapy or family-based treatment for adolescent bulimia nervosa. Eur Eat Disord Rev. 2018 May;26(3):253-258. doi: 10.1002/erv.2582. Epub 2018 Feb 15.'}, {'pmid': '26506579', 'type': 'DERIVED', 'citation': 'Le Grange D, Lock J, Agras WS, Bryson SW, Jo B. Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa. J Am Acad Child Adolesc Psychiatry. 2015 Nov;54(11):886-94.e2. doi: 10.1016/j.jaac.2015.08.008. Epub 2015 Sep 2.'}, {'pmid': '25146149', 'type': 'DERIVED', 'citation': 'Darcy AM, Fitzpatrick KK, Manasse SM, Datta N, Klabunde M, Colborn D, Aspen V, Stiles-Shields C, Labuschagne Z, Le Grange D, Lock J. Central coherence in adolescents with bulimia nervosa spectrum eating disorders. Int J Eat Disord. 2015 Jul;48(5):487-93. doi: 10.1002/eat.22340. Epub 2014 Aug 22.'}, {'pmid': '23001391', 'type': 'DERIVED', 'citation': 'Darcy AM, Fitzpatrick KK, Colborn D, Manasse S, Datta N, Aspen V, Shields CS, Le Grange D, Lock J. Set-shifting among adolescents with bulimic spectrum eating disorders. Psychosom Med. 2012 Oct;74(8):869-72. doi: 10.1097/PSY.0b013e31826af636. Epub 2012 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'In the face of scant literature on the subject, the investigators aim to more clearly identify effective treatments for adolescent bulimia nervosa (BN) through a treatment study comparing two current treatments (Cognitive Behavioral Therapy for Adolescents, CBT-A and Family Based Therapy for Bulimia Nervosa, FBT-BN) for the disorder in comparison with a non-specific therapy, Supportive Psychotherapy for Adolescent Bulimia (SPT). Additionally, the investigators hope to provide clinicians with information on treatment efficacy, variables that might influence outcome, and processes that may affect treatment efficacy that will guide them in their efforts to treat adolescent BN.', 'detailedDescription': "BN is a serious disorder that is characterized by extreme concerns about body weight and shape, dieting, and the disinhibited eating behaviors of binging and purging. There are no published randomized clinical trials of psychotherapy treatment for Bulimia Nervosa in adolescents although it often onsets in this age group. There is evidence that some treatments are effective, but none has been empirically tested. Because Bulimia Nervosa is a serious medical and psychiatric illness it is important to learn efficacious ways to treat this disorder, especially in its early stages. Treatments used in this study are the best known treatments for adults with Bulimia Nervosa. The investigators hope to learn which of two previously studied treatments might be superior to the other, in an effort to guide clinicians in treatment choices. Successfully treating the disorder early on (even in those adolescents with partial BN, characterized by binge eating and purging at least one time per week over a 6 month period) may reduce the number of cases requiring treatment during adulthood, leading to possible reduction in severity of associated psychopathology and lower costs, as well as enable individuals to lead more productive lives.\n\nGiven the neglect of adolescent BN in the research literature and the need for information to guide the clinical treatment of this disorder, this study's primary aim is to compare the efficacy of CBT-A to FBT-BN in decreasing binge eating and purging episodes in adolescents with BN and partial BN (defined as binge eating and purging at least one time per week for the past six months).\n\nParticipation in this study will last 1 and a half years and will consist of 6 months of treatment and a follow-up session at 6 and 12 months post-treatment. All participants will first undergo baseline assessments, which include interviews and questionnaires about psychological history and BN symptoms, and an Eating Disorder Examination (EDE) interview. All treatment assignments consist of 18 sessions of therapy over the course of 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants will be adolescents living with at least one of their parents and between the ages of 12 and 18 years of age with a DSM IV diagnosis of BN or partial BN (binge eating and purging at least one time per week over a six month period).\n2. Males meeting inclusion criteria will also be entered into the study. They must have age-adjusted BMI greater than 17.5, or ideal body weight (IBW) \\> 85%.\n3. Family, for the purposes of this study, includes members of the subject's household, including at least one parent or adult guardian. Single parent families, divorced families, step-parents, and other types of families will be allowed to enter the study.\n\nExclusion Criteria:\n\n1. psychotic illness or other mental illness requiring hospitalization; bipolar I disorder, depression with active suicidal thoughts and behavior;\n2. associated physical illness that necessitates hospitalization;\n3. current dependence on drugs or alcohol;\n4. current diagnosis of anorexia nervosa or weight less that 85% IBW;\n5. physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight;\n6. currently taking medication for co-morbid conditions for less than 2-months;\n7. currently taking medications that may induce weight loss, e.g., appetite suppressants such as sibutramine, phentermine, and xenical, unless the participant is willing to withdraw from such medications;\n8. currently taking medications for symptoms of BN and unwilling to discontinue these prior to initiating treatment in the study\n9. previous CBT or FBT treatment for BN\n10. married subjects\n11. emancipated minors\n12. family members will be excluded from engaging in treatment for the following reasons:\n\n * Current or history of sexual or physical abuse of the patient by family members. Perpetrators of the abuse will be excluded from treatment. Should sexual or physical abuse by a family member occur during the course of treatment, perpetrators will be excluded from ongoing treatment.\n * Substance dependence, psychosis, or severe medical illness that would limit full participation in therapy, or that might put the family member at risk for worsening of their condition during treatment. The decision whether or not to allow these individuals to continue to participate in treatment will be made by the therapist in consultation with the treatment supervisor."}, 'identificationModule': {'nctId': 'NCT00879151', 'briefTitle': 'Study of Treatment for Adolescents With Bulimia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Treatment of Bulimic Adolescents', 'orgStudyIdInfo': {'id': 'SU-02272009-1878'}, 'secondaryIdInfos': [{'id': 'eProtocol Number 132056'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychotherapy', 'description': 'Patients are randomized to one of three different types of psychotherapy: Cognitive-Behavioral Therapy for adolescents, Family-Based Therapy for Bulimia Nervosa, and Supportive Psychotherapy. All treatments consist of 18 sessions over a period of approximately 6 months.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Adolescents', 'Behavioral: Supportive Psychotherapy', 'Behavioral: Family Based Therapy for Bulimia Nervosa']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy for Adolescents', 'type': 'BEHAVIORAL', 'description': 'The therapist will work with the adolescent to understand triggers to binge eating and purging, such as thoughts, feelings, and interpersonal difficulties. Also, establishing regular eating patterns and eliminating medically harmful behaviors associated with the eating disorder is a primary goal.', 'armGroupLabels': ['Psychotherapy']}, {'name': 'Supportive Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'SPT focuses on having the patient build a relationship with the therapist and explore their unique individual needs within the context of their life and the experience of having an eating disorder.', 'armGroupLabels': ['Psychotherapy']}, {'name': 'Family Based Therapy for Bulimia Nervosa', 'type': 'BEHAVIORAL', 'description': "FBT helps parents to take an active role in guiding their child through eating disorder treatment. In this therapy, the parents are supported in helping their child stop bingeing, purging and engaging in other harmful weight-control behaviors. The way in which the eating disorder has impacted the family and the adolescent's development is also explored.", 'armGroupLabels': ['Psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'James D Lock', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry and Behavioral Sciences', 'investigatorFullName': 'James Dale Lock', 'investigatorAffiliation': 'Stanford University'}}}}