Stepped Care Treatment for Binge-Eating

Binge Eating Disorder Clinical Trial

Official title:

Dialectical Behavior Therapy for Early Non-Responders to CBT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965705
• Other study ID #: 20472
• Secondary ID: K23MH081030-01
• Status: Completed
• Phase: N/A
• First received: August 25, 2009
• Last updated: April 18, 2018
• Start date: June 2009
• Est. completion date: March 2017

Study information

• Verified date: April 2018
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders

Intervention

Behavioral:
• Therapy
Individual Therapy and Group Therapy

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chen EY, Cacioppo J, Fettich K, Gallop R, McCloskey MS, Olino T, Zeffiro TA. An adaptive randomized trial of dialectical behavior therapy and cognitive behavior therapy for binge-eating. Psychol Med. 2017 Mar;47(4):703-717. doi: 10.1017/S0033291716002543. — View Citation

Southward MW, Christensen KA, Fettich KC, Weissman J, Berona J, Chen EY. Loneliness mediates the relationship between emotion dysregulation and bulimia nervosa/binge eating disorder psychopathology in a clinical sample. Eat Weight Disord. 2014 Dec;19(4):5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Temple University Eating Disorders (TED) Website