Stepped Care Treatment for Binge-Eating

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Temple University

Status

Completed

Conditions

Binge Eating Disorder

Treatments

Behavioral: Therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00965705
K23MH081030-01 (U.S. NIH Grant/Contract)
20472

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

109 participants in 3 patient groups

Guided Self Help
Active Comparator group
Treatment:
Behavioral: Therapy
Cognitive Behavioral Therapy
Active Comparator group
Treatment:
Behavioral: Therapy
Dialectical Behavioral Therapy
Active Comparator group
Treatment:
Behavioral: Therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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