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
|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|
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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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)
- 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
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
|Contact: Rowan Hunt, BAfirstname.lastname@example.org|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Rowan Hunt, BA 215-553-7186 email@example.com|
|Principal Investigator: Adrienne S Juarascio, PhD|
|Principal Investigator:||Adrienne S Juarascio, PhD||Drexel University|