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Study ID: NCT00965705

Title: Treatment for Difficult to Treat Eating and Weight Disorders

Status:
Recruiting
Phase:
0

Trial Contact Information

Principal Contact:
Stephanie Harold
Principal Phone:
773-834-9120
Principal Email:
sharold@yoda.bsd.uchicago.edu

Sponsor(s): National Institute of Mental Health (NIMH), University of Chicago

Condition(s):
Eating Disorders
Bulimia nervosa
Compulsive Eating
Binge-eating disorder
Bulimia
Eating Disorder
Binge Eating Disorder

Purpose: The University of Chicago 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.

Eligibility:
Minimum Age:
18 Years
Maximum Age:
60 Years
Accepts Healthy Volunteers:
Yes

Inclusion Criteria:

- Adult female, 18 years to 60 years

- Meets DSM-IV criteria for Binge Eating Disorder

- Resides within commuting distance to the UC

- 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 (4 sessions
of guided self-help 30 minutes per session) and if this does not work for them, that
they will receive more intensive treatment including both groups (2 hours) and
individual (50 minutes) treatment (group and individual involves 24-30 weeks of
treatment). If they respond well to individual treatment alone, they will continue in
individual treatment for the remaining 6 months of the study.

- 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

Other Location(s): Chicago, Illinois United States

Terms: This is an abstract courtesy of ClinicalTrials.gov, a service of the US National Institute of Health Developed by the National Library of Medicine. ClinicalTrials.gov provides regularly updates information about federally and privately supported clinical research in human volunteers.

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