Adrienne S. Juarascio, Ph.D. - US grants

? DESCRIPTION (provided by applicant): The current project is a re-submission for a K23 award for Dr. Adrienne Juarascio, an Assistant Research Professor at Drexel University. Dr. Juarascio is establishing herself as an early-career investigator in patient oriented research with a focus on innovative treatment development for eating disorders. In particular, Dr. Juarascio is interested in using experimental therapeutics approaches to improve existing treatments for subgroups who experience minimal improvement from existing treatments. This K23 award will provide Dr. Juarascio with the necessary support to accomplish the following goals: (1) Develop expertise in the mechanisms of existing gold-standard treatments for eating pathology and moderators of response to treatment, (2) attain the skills and knowledge necessary to design, conduct, and evaluate clinical trials in outpatient settings, (3) gain experience with assessment techniques for hypothesized maintenance factors in eating pathology, with a focus on bio-behavioral assessment procedures, (4) build proficiency with multi-level and longitudinal analytic approaches related to clinical trial research, and (5) increase skills related to manuscript preparation, grant writing and management, clinical supervision, and academic leadership. To achieve these goals, Dr. Juarascio has assembled a mentoring team comprised of two co-primary mentors (Dr. Michael Lowe and Dr. Evan Forman), two co-mentors (Dr. Carl Lejuez, and Dr. Matthew Hayes) and two consultants (Dr. Carlos Grilo and Dr. Robert Gallop) with whom she has created a training plan that will provide her with the skills needed to become a successful federally-funded independent investigator. As part of this training plan, Dr. Juarascio will develop and assess a novel treatment (Nutritional Counseling and Acceptance-based Treatment, N-CAAT) for patients with bulimia nervosa (BN) who are high in weight suppression, a factor associated with the development and maintenance of BN symptoms and with poor treatment outcome. The poor outcomes for this sub-group are likely due to the predictable weight gain that occurs once normal eating behavior resumes. Although weight gain can reduce the biobehavioral bind that promotes continued pathology, weight gain can also be distressing and promote continued engagement in maladaptive eating behaviors. Innovative treatments that address core maintenance factors are needed to improve outcome. The proposed project will consist of three phases, with Phase I focusing on the creation of a treatment manual, Phase II pilot testing the manual in a small sample and assessing target engagement, and Phase III testing the feasibility, acceptability, target engagement, and target validation of N-CAAT in a small pilot RCT. The primary study aims will be to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, and implementation of the novel treatment to enhance the probability of success in subsequent RCTs. This research will form the basis of a randomized interventional trial that will be submitted in an R01 grant application before the end of the K23 award.

PROJECT SUMMARY/ABSTRACT Binge eating disorder (BED) is the most prevalent eating disorder and is associated with substantial psychiatric and medical comorbidity. Although obesity is not part of the diagnostic criteria for BED, more than 65% of individuals with BED are obese, and more than a quarter of patients seeking treatment for obesity present with BED. To date, although there exist several effective treatments for reducing binge eating, facilitating clinically significant weight loss in patients with BED remains a challenge. We believe the failure of existing treatment approaches is related to 1) a lack of emphasize on altering the calorie balance (through both diet and physical activity) without encouraging strict dietary restraint that could promote an eventual re- occurrence of binge eating pathology, 2) limited strategies designed to promote long-term adherence to dietary and physical activity goals, and 3) the failure of both standard behavioral weight loss treatments (SBT) and cognitive behavioral therapy (CBT) to address key maintenance factors for BED (e.g. elevated food reward sensitivity, overvaluation of weight and shape, negative affect and distress intolerance). Acceptance-based behavioral treatment (ABBT) can provide individuals with the psychological tools necessary to improve negative affect, distress intolerance, and overvaluation of weight and shape and support long-term adherence to the dietary and physical activity recommendations designed to produce weight loss despite elevated food reward sensitivity. Our existing pilot data support the ability of ABBTs to produce superior weight loss outcomes both for obese patients at large and for obese patients with vulnerabilities similar to those observed in BED. ABBTs have also been shown to effectively reduce binge eating episodes in BED. Our pilot data suggests that ABBT could produce superior weight loss outcomes for patients with BED compared to SBT. The primary goal of the proposed project is to evaluate the efficacy of ABBT in relation to SBT for facilitating weight loss and weight loss maintenance in patients with BED. A secondary goal is to test hypothesized mechanisms of action of the two treatments, both during active intervention and during the post-treatment weight loss maintenance phase. Lastly, we aim to evaluate moderation hypotheses stating that the superiority of ABBT will be especially pronounced for those with higher food reward sensitivity, overvaluation of weight and shape, negative affect, and distress intolerance. Our aims work towards longer-range goals of identifying more effective methods for improving weight loss outcomes, using evidence to maximize the effective components of interventions, and matching patients to treatment type. Accordingly, we will randomly assign 130 overweight and obese patients with BED to 25 sessions of ABBT or SBT. All participants will be followed until one year post-treatment. Lab-based behavioral assessments, clinician guided interventions, and self- report measures will be used to provide a multi-method assessment of hypothesized moderating and mediating pathways, and how these associations are affected by treatment.

Project Summary/Abstract An overarching goal of cognitive behavioral therapies (CBTS) is to improve skill acquisition (i.e. the ability to successfully perform a skill learned in treatment) and skill utilization (i.e. the frequency with which a patient practices or employs therapeutic skills). However, many patients receiving CBT fail to achieve sufficient rates of skill utilization or adequate skill acquisition and treatment outcomes suffer as a result. Augmentations to CBT that improve skill utilization and acquisition could result in substantial improvements in treatment outcome for a variety of mental health disorders. Ecological momentary interventions (EMIs) are a promising method for improving skill utilization and acquisition in CBT. EMIs provide assistance when and where individuals are most in need (typically through smartphone applications). Smartphone-based EMI systems now have the capability to deliver interventions at the precise moment when these interventions are most needed using algorithm-based context-aware systems. An EMI system designed to increase skill utilization and acquisition could 1) detect when a patient should practice using a therapeutic skill and 2) provide a tailored interventions designed to facilitate skill use at the time when receiving an intervention would be most impactful. Despite the increased development and widespread use of both smartphone app technologies and EMI systems, there currently exists limited data to suggest whether smartphone-based EMI systems can successfully improve skill acquisition and utilization when used as an adjunct to in-person CBT. Patients with bulimia nervosa (BN), a disorder characterized by recurrent episodes of binge eating and purging imposed on top of an otherwise highly restrictive diet, may represent an ideal group to test the utility of a skills-based EMI system. We chose to augment CBT for BN for three reasons: (1) Symptom improvement in CBT for BN can be explained by improvements in a relatively small number of concrete and measureable therapeutic skills, (2) acquisition and utilization of these skills is often poor in CBT for BN and poor skill acquisition and utilization is strongly related to treatment failure, and (3) the barriers to skill acquisition and utilization in CBT for BN are likely addressable by EMI augmentation. In the current study, we propose to develop, refine, and test an EMI system (CBT+) that will use data collected from standard CBT for BN electronic self-monitoring forms to identify when patients should use CBT skills. In Phase 1, we will develop CBT+ (based on prior EMI-systems developed by our team) and will use an iterative development approach (n=10) to ensure CBT+ achieves acceptable target engagement. Using a single-case ABAB design (A= EMI on, B= EMI off), we will evaluate the ability of CBT+ to 1) increase utilization of six core skills in CBT for BN during ?EMI on? phases and 2) produce more rapid gains in skill acquisition during ?EMI on? phases. In Phase 2, we will complete a pilot RCT (n=45) comparing standard CBT for BN (n=15) to CBT for BN augmented with CBT+ (n=30) to assess the feasibility and acceptability of CBT+ and evaluate target engagement and validation.

PROJECT SUMMARY Cognitive Behavioral Therapy (CBT) is typically considered the current gold standard and first line treatment for disorders characterized by recurrent binge eating such as bulimia nervosa (BN) and binge eating disorder (BED). Outcomes, while clinically significant, leave substantial room for improvement with recent systematic reviews and meta-analyses finding that 40-50% of patients with BED and nearly 70% of patients with BN remain at least partially symptomatic after a full course of CBT. In an effort to improve outcomes, a growing number of researchers have begun to evaluate the use of mindfulness and acceptance-based behavioral treatments (MABTs) for BN and BED and preliminary evidence suggests such treatments can be effective for this population. Although the research on MABTs for binge eating remains nascent, MABTs are frequently used in clinical practice for BN and BED, with one recent study showing that patients are more likely to report that their therapist has used mindfulness-based techniques than CBT-specific techniques. Given the widespread clinical interest in MABTs and the growing body of research supporting the preliminary efficacy of these treatments, a fully powered tests of the efficacy, mechanisms of action, and moderators of outcome for MABT appears warranted. In particular, rather than testing any specific MABT treatment package (e.g. acceptance and commitment therapy, dialectical behavioral therapy, mindfulness-based eating interventions) in a large clinical trial, we believe that a study that can isolate and evaluate the independent and synergistic efficacy of the most commonly used MABT components has the highest potential for impact. A review of MABTs for BN and BED suggests that there are four commonly used MABT components: (1) Mindful Awareness, (2) Distress Tolerance, (3) Emotion Modulation, and (4) Values-Based Decision Making. MABT treatment packages have vary widely in which of these components they incorporated and which they emphasized. By identifying which components of MABTs are most effective (and for whom they are effective), we can emphasize the powerful elements of MABTs and deemphasize or eliminate inert components. A traditional RCT would not provide the power necessary to evaluate the independent and synergistic efficacies of four distinct treatment components compared to an active treatment approach such as CBT. Instead, the proposed study will use a Multiphasic Optimization Strategy (MOST) approach (including a full factorial design) in which 256 individuals with transdiagnostic binge eating pathology are assigned to one of sixteen behavioral treatments, i.e., representing each permutation of the MABT component described above being included or excluded from the base treatment (a version of CBT that emphasizes the key behavioral ingredients of this treatment approach). Results of the component analysis set up future work to evaluate an optimized treatment containing only effective components (which can be expected to have superior efficacy, efficiency and disseminability) against current gold-standard CBT.