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Stepped Care Treatment for Binge-Eating

Dialectical Behavior Therapy for Early Non-Responders to CBT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00965705
Enrollment
109
Registered
2009-08-26
Start date
2009-06-30
Completion date
2017-03-31
Last updated
2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating Disorder

Keywords

Binge Eating Disorder, overeating, binge eating, women, overweight, compulsive overeating

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.

Interventions

BEHAVIORALTherapy

Individual Therapy and Group Therapy

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last monthUp to 12 months after randomizationNumber of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026