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

Primary Purpose

Bulimia Nervosa, Bulimia, Binge Eating

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional Counseling & Acceptance-based Therapy
Cognitive Behavioral Therapy for Eating Disorders
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Bulimia Nervosa, Eating Disorders, Binge Eating, Bulimia, Purging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drexel UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Counseling & Acceptance-based Therapy

Cognitive Therapy for Eating Disorders

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body Mass Index (BMI)
Body Mass Index (BMI) will be assessed to ensure weight remains in a healthy range and to track weight change
Broader Psychological Functioning assessed by the Symptom Checklist-90-Revisited
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

Full Information

First Posted
March 11, 2016
Last Updated
September 12, 2018
Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02716831
Brief Title
Improving Treatments for Bulimia Nervosa: Innovation in Psychological Interventions for Regulating Eating
Acronym
INSPIRE
Official Title
Addressing Weight History to Improve Behavioral Treatments for Bulimia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Bulimia, Binge Eating, Purging (Eating Disorders), Eating Disorder
Keywords
Bulimia Nervosa, Eating Disorders, Binge Eating, Bulimia, Purging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Counseling & Acceptance-based Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Therapy for Eating Disorders
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Counseling & Acceptance-based Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Eating Disorders
Primary Outcome Measure Information:
Title
Binge and purge frequency assessed by the Eating Disorder Examination (EDE)
Description
Binge and purge frequency as assessed by the Eating Disorder Examination (EDE)
Time Frame
Change from Baseline Binge and Purge Frequency at 5 months and 11 months
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Body Mass Index (BMI) will be assessed to ensure weight remains in a healthy range and to track weight change
Time Frame
Change from Baseline BMI at 1 month, 3 months, 5 months, and 11 months
Title
Broader Psychological Functioning assessed by the Symptom Checklist-90-Revisited
Description
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
Time Frame
Change from Baseline Symptom Checklist-90 Revisited at 1 month, 3 months, 5 months, and 11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rowan Hunt, BA
Phone
215-553-7186
Email
edresearch@drexel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne S Juarascio, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rowan Hunt, BA
Phone
215-553-7186
Email
edresearch@drexel.edu
First Name & Middle Initial & Last Name & Degree
Adrienne S Juarascio, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34643949
Citation
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.
Results Reference
derived
Links:
URL
http://drexel.edu/coas/academics/departments-centers/well-center/research/current-research-projects/
Description
For more information, please email edresearch@drexel.edu or call 215-553-7186

Learn more about this trial

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

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