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

September 12, 2018 updated by: Drexel University

Addressing Weight History to Improve Behavioral Treatments for Bulimia Nervosa

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Bulimia nervosa (BN) is an eating disorder characterized by a pattern of binge eating and compensatory behaviors as well as an overemphasis on body weight and shape in self-evaluation. BN has a lifetime prevalence rate of 1-3% and is associated with numerous psychiatric and medical complications. Cognitive behavioral therapy (CBT) is regarded as the gold-standard treatment for BN and the treatment approach with the most empirical support to date. However, although CBT has accumulated impressive empirical support for its effectiveness, CBT produces abstinence from binge eating and purging in only 30-50% of treatment completers. Furthermore, relapse is common and many individuals do not maintain treatment gains. Innovative treatments that can improve rates of remission among patients with BN and related disorders are sorely needed for bulimia nervosa and related eating disorders, particularly for individuals for whom existing treatments fail.

Existing CBT may be enhanced by incorporating acceptance-based behavioral strategies and nutritional counseling to help patients eliminate BN symptoms. Acceptance-based behavioral treatments (ABBTs) emphasize "changing what you can and accepting what you can't", which refers to a focus on learning how to accept and tolerate distressing internal experiences (e.g., thoughts, emotions, urges, physical sensations) that might not be directly under the patients' control while choosing to engage in adaptive behavioral choices that are within their control. Patients may benefit from the provision of more adaptive behavioral strategies to maintain weight in a healthy range, which is not a primary goal of existing behavioral treatments. Nutritional counseling (NC), which is designed to promote healthy, non-rigid dietary restraint and exercise habits, can lead to improvements in weight control that may also improve disordered eating behaviors. As described above, a primary maintenance factor for BN is the strict and rigid dieting behavior that triggers urges to binge. Several studies have indicated that the provision of healthy restraint strategies to patients with BN can reduce binge eating and purging behaviors, suggesting that this approach can be an effective treatment alone or in combination with other behavioral techniques.

Study Objectives-

  • Test the feasibility, acceptability, and preliminary efficacy of Nutritional Counseling And Acceptance-based Therapy (N-CAAT) for bulimia nervosa (BN) in a small pilot RCT trial
  • Assess the mechanisms of action to enhance treatment development
  • Evaluate the feasibility of recruitment, randomization, retention, assessment procedures, and implementation of the novel treatment to enhance the probability of success in subsequent larger RCTs

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Drexel University
        • Contact:
        • Principal Investigator:
          • Adrienne S Juarascio, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Counseling & Acceptance-based Therapy
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
ACTIVE_COMPARATOR: Cognitive Therapy for Eating Disorders
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binge and purge frequency assessed by the Eating Disorder Examination (EDE)
Time Frame: Change from Baseline Binge and Purge Frequency at 5 months and 11 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Change from Baseline BMI at 1 month, 3 months, 5 months, and 11 months
Body Mass Index (BMI) will be assessed to ensure weight remains in a healthy range and to track weight change
Change from Baseline BMI at 1 month, 3 months, 5 months, and 11 months
Broader Psychological Functioning assessed by the Symptom Checklist-90-Revisited
Time Frame: Change from Baseline Symptom Checklist-90 Revisited at 1 month, 3 months, 5 months, and 11 months
Broader psychological functioning will be assessed by the Symptom Checklist-90-Revisited (SC) which assesses a broad range of psychological problems and symptoms of psychopathology
Change from Baseline Symptom Checklist-90 Revisited at 1 month, 3 months, 5 months, and 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Adrienne S Juarascio, PhD, Drexel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (ESTIMATE)

March 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1501003366
  • 1K23MH105680-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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