Stepped Care Treatment for Binge-Eating

Study Overview
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Brief Summary
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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.

Official Title
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Dialectical Behavior Therapy for Early Non-Responders to CBT

Conditions
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Binge Eating Disorder

Intervention / Treatment
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* Behavioral: Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 18-24 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guided Self Help<br> | Behavioral: Therapy<br>* Individual Therapy and Group Therapy<br>|
| Active Comparator: Cognitive Behavioral Therapy<br> | Behavioral: Therapy<br>* Individual Therapy and Group Therapy<br>|
| Active Comparator: Dialectical Behavioral Therapy<br> | Behavioral: Therapy<br>* Individual Therapy and Group Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge Eating Disorder, overeating, binge eating, women, overweight, compulsive overeating