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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

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.

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Bulimia Binge Eating Purging (Eating Disorders) Eating Disorder Behavioral: Nutritional Counseling & Acceptance-based Therapy Behavioral: Cognitive Behavioral Therapy for Eating Disorders Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addressing Weight History to Improve Behavioral Treatments for Bulimia Nervosa
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716831


Contacts
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Contact: Rowan Hunt, BA 215-553-7186 edresearch@drexel.edu

Locations
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United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rowan Hunt, BA    215-553-7186    edresearch@drexel.edu   
Principal Investigator: Adrienne S Juarascio, PhD         
Sponsors and Collaborators
Drexel University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Adrienne S Juarascio, PhD Drexel University

Additional Information:
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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT02716831     History of Changes
Other Study ID Numbers: 1501003366
1K23MH105680-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: August 2018

Keywords provided by Drexel University:
Bulimia Nervosa
Eating Disorders
Binge Eating
Bulimia
Purging

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Bulimia Nervosa
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms