Improving Treatments for Bulimia Nervosa: Innovation in Psychological Interventions for Regulating Eating

NCT02716831 | Unknown DMC

• 2 other identifiers: 15010033661K23MH105680-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test a novel, acceptance-based behavioral treatment for bulimia nervosa (BN) in adults. This treatment is a type of individual psychotherapy called Nutritional Counseling And Acceptance-Based Therapy (N-CAAT) that enhances existing cognitive behavioral therapy (CBT) for BN by incorporating acceptance-based behavioral strategies and nutritional counseling to help patients eliminate BN symptoms.

Conditions

Bulimia Nervosa; Bulimia; Binge Eating; Purging (Eating Disorders); Eating Disorder

Keywords

Bulimia Nervosa; Eating Disorders; Binge Eating; Bulimia; Purging

Outcome Measures

Primary Outcomes (1)

• Binge and purge frequency assessed by the Eating Disorder Examination (EDE)

  Binge and purge frequency as assessed by the Eating Disorder Examination (EDE)

  Change from Baseline Binge and Purge Frequency at 5 months and 11 months

Secondary Outcomes (2)

• Body Mass Index (BMI)

  Change from Baseline BMI at 1 month, 3 months, 5 months, and 11 months

• Broader Psychological Functioning assessed by the Symptom Checklist-90-Revisited

  Change from Baseline Symptom Checklist-90 Revisited at 1 month, 3 months, 5 months, and 11 months

Study Arms (2)

Counseling & Acceptance-based Therapy

EXPERIMENTAL

Nutritional Counseling \& Acceptance-based Therapy (N-CAAT) incorporates acceptance-based behavioral strategies and nutritional counseling designed to encourage willingness to tolerate distress and the ability to pursue chosen values in an adaptive manner despite distressing internal experiences. In addition to these skills, a principal focus of the treatment will be on identifying, practicing, and achieving behavioral goals, such as normalization of eating, reduction of maladaptive dietary restraint and restriction, and elimination of compensatory behaviors.

Behavioral: Nutritional Counseling & Acceptance-based Therapy

Cognitive Therapy for Eating Disorders

ACTIVE COMPARATOR

Participants in the Cognitive Behavioral Therapy for Eating Disorders (CBT) condition will receive 20-sessions of standard CBT for eating disorders based on the treatment approach developed by Dr. Christopher Fairburn and published in his book Cognitive Behavioral Therapy and Eating Disorders.

Behavioral: Cognitive Behavioral Therapy for Eating Disorders

Interventions

Nutritional Counseling & Acceptance-based Therapy BEHAVIORAL

Counseling & Acceptance-based Therapy

Cognitive Behavioral Therapy for Eating Disorders BEHAVIORAL

Cognitive Therapy for Eating Disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets Diagnostic Statistical Manual(DSM)-5 criteria for Bulimia Nervosa
• Age 18 or above

You may not qualify if:

• Body Mass Index (BMI) below 85% of ideal body weight or other medical complications that prevent ability to engage in outpatient treatment
• Acute suicide risk
• Co-morbid diagnosis of a psychotic disorder, bipolar disorder, or substance dependence
• Diagnosis of mental retardation or a pervasive development disorder
• Current pregnancy

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• Parker MN, Wilkinson ML, Hunt RA, Ortiz A, Manasse SM, Juarascio AS. Eating expectancies and hedonic hunger among individuals with bulimia-spectrum eating disorders who plan binge-eating episodes. Int J Eat Disord. 2022 Jan;55(1):120-124. doi: 10.1002/eat.23628. Epub 2021 Oct 13.

  PMID: 34643949 DERIVED

Related Links

• For more information, please email edresearch@drexel.edu or call 215-553-7186

MeSH Terms

Conditions

Bulimia Nervosa; Bulimia; Feeding and Eating Disorders

Interventions

Nutrition Assessment; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adrienne S Juarascio, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rowan Hunt, BA

CONTACT

215-553-7186; edresearch@drexel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 23, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 14, 2018

Record last verified: 2018-08

Locations

US (1)