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

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ClinicalTrials.gov Identifier: NCT02716831
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Drexel University

Tracking Information
First Submitted Date  ICMJE March 11, 2016
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date September 14, 2018
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02716831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Treatments for Bulimia Nervosa: Innovation in Psychological Interventions for Regulating Eating
Official Title  ICMJE Addressing Weight History to Improve Behavioral Treatments for Bulimia Nervosa
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bulimia Nervosa
  • Bulimia
  • Binge Eating
  • Purging (Eating Disorders)
  • Eating Disorder
Intervention  ICMJE
  • Behavioral: Nutritional Counseling & Acceptance-based Therapy
  • Behavioral: Cognitive Behavioral Therapy for Eating Disorders
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Cognitive Behavioral Therapy for Eating Disorders
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rowan Hunt, BA 215-553-7186 edresearch@drexel.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02716831
Other Study ID Numbers  ICMJE 1501003366
1K23MH105680-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Drexel University
Study Sponsor  ICMJE Drexel University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Adrienne S Juarascio, PhD Drexel University
PRS Account Drexel University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP