Stepped Care Treatment for Binge-Eating
Dialectical Behavior Therapy for Early Non-Responders to CBT
2 other identifiers
interventional
109
1 country
1
Brief Summary
Temple University is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder. Binge-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedApril 20, 2018
April 1, 2018
7.8 years
August 25, 2009
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Up to 12 months after randomization
Study Arms (3)
Guided Self Help
ACTIVE COMPARATORCognitive Behavioral Therapy
ACTIVE COMPARATORDialectical Behavioral Therapy
ACTIVE COMPARATORInterventions
Individual Therapy and Group Therapy
Eligibility Criteria
You may qualify if:
- Adult female, 18 years to 60 years
- Meets DSM-IV criteria for Binge Eating Disorder
- Resides within commuting distance
- Consents to research protocol, i.e.
- months in assessment and treatment
- willing to be part of a biological assessment/physiological assessment
- 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.
- agreement not to see other health professionals unless recommended
- seeing their own Primary care Physician/Nurse Practitioner for medical screening prior to study (i.e., before being allocated a guided self-help therapist)
- payment for their own medical assessment, monitoring, and medication if needed
You may not qualify if:
- Anorexia nervosa
- Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS, or Bipolar Mood Disorder
- Needs priority treatment for other debilitating conditions, e.g. current substance dependence requiring inpatient detox
- chronic absence of shelter
- IQ less than 70
- 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)
- Is pregnant, plans to become pregnant during treatment, or becomes pregnant before random assignment to study condition
- Medical instability
- Has had or is seeking Gastric bypass surgery
- On anti-seizure medication, beta-blockers, asthma medication, medication for heart disease, or any other medication that affects appetite or weight
- Psychotropics are acceptable if the doses are stable for at least 3 months prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Temple Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Temple University
Philadelphia, Pennsylvania, 19122, United States
Related Publications (2)
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: 27852348RESULTSouthward 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.
PMID: 24235091RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eunice Y Chen, PHD
Temple University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
August 25, 2009
First Posted
August 26, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
April 20, 2018
Record last verified: 2018-04