Stepped Care Treatment for Binge-Eating
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Binge Eating Disorder |
Behavioral: Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Dialectical Behavior Therapy for Early Non-Responders to CBT |
- symptom improvement [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Guided Self Help |
Behavioral: Therapy
Individual Therapy and Group Therapy
|
| Active Comparator: Cognitive Behavioral Therapy |
Behavioral: Therapy
Individual Therapy and Group Therapy
|
| Active Comparator: Dialectical Behavioral Therapy |
Behavioral: Therapy
Individual Therapy and Group Therapy
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| 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
- 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
Contacts and Locations| Contact: Eunice Y Chen, PhD | (215) 204-2645 | eunice.chen@temple.edu |
| United States, Pennsylvania | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19122 | |
| Contact: Eunice Y Chen, PhD 215-204-2645 eunice.chen@temple.edu | |
| Principal Investigator: Eunice Y Chen, PhD | |
| Principal Investigator: | Eunice Y Chen, PHD | Temple University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Chen, Study Principal Investigator, Temple University |
| ClinicalTrials.gov Identifier: | NCT00965705 History of Changes |
| Other Study ID Numbers: | 20472, K23MH081030-01 |
| Study First Received: | August 25, 2009 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Temple University:
|
Binge Eating Disorder overeating binge eating |
women overweight compulsive overeating |
Additional relevant MeSH terms:
|
Bulimia Binge-Eating Disorder Eating Disorders Hyperphagia |
Signs and Symptoms, Digestive Signs and Symptoms Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013