Optimizing digital health technologies to improve therapeutic skill use and acquisition alongside enhanced cognitive-behavior therapy for binge-spectrum eating disorders: Protocol for a randomized controlled trial.

OBJECTIVE: Adjunctive mobile health (mHealth) technologies offer promise for improving treatment response to enhanced cognitive-behavior therapy (CBT-E) among individuals with binge-spectrum eating disorders, but research on the key "active" components of these technologies has been very limited. The present study will use a full factorial design to (1) evaluate the optimal combination of complexity of two commonly used mHealth components (i.e., self-monitoring and microinterventions) alongside CBT-E and (2) test whether the optimal complexity level of these interventions is moderated by baseline self-regulation. Secondary aims of the present study include evaluating target engagement associated with each level of these intervention components and quantifying the component interaction effects (i.e., partially additive, fully additive, or synergistic effects). METHOD: Two hundred and sixty-four participants with binge-spectrum eating disorders will be randomized to six treatment conditions determined by the combination of self-monitoring condition (i.e., standard self-monitoring or skills monitoring) and microinterventions condition (i.e., no microinterventions, automated microinterventions, or just-in-time adaptive interventions) as an augmentation to 16 sessions of CBT-E. Treatment outcomes will be measured using the Eating Disorder Examination and compared by treatment condition using multilevel models. RESULTS: Results will clarify the "active" components in mHealth interventions for binge eating. DISCUSSION: The present study will provide critical insight into the efficacy of commonly used digital intervention components (i.e., skills monitoring and microinterventions) alongside CBT-E. Furthermore, results of this study may inform personalization of digital intervention intensity based on patient profiles of self-regulation. PUBLIC SIGNIFICANCE: This study will examine the relative effectiveness of commonly used components of application-based interventions as an augmentation to cognitive-behavioral therapy for binge eating. Findings from this study will inform the development of an optimized digital intervention for individuals with binge eating.

Testing a Conceptual Model of Early Adversity, Neural Function, and Psychopathology: Protocol for a Retrospective Observational Cohort Study.

BACKGROUND: Early adversity, broadly defined as a set of negative exposures during childhood, is extremely common and increases risk for psychopathology across the life span. Previous research suggests that separate dimensions of adversity increase risk through developmental plasticity mechanisms shaping unique neurobiological pathways. Specifically, research suggests that deprivation is associated with deficits in higher order cognition, while threat is associated with atypicality in fear learning and emotion dysregulation. However, most of this research has been conducted in adolescent and adult samples, long after exposure to adversity occurs and far from periods of peak developmental plasticity. OBJECTIVE: The Wellness Health and Life Experiences (WHALE) study examines the neurobiological and behavioral mechanisms by which deprivation, threat, and unpredictability increase risk for psychopathology in early childhood (age 4-7 years) directly following periods of peak developmental plasticity. The objective of this study is to describe the study rationale and aims, the research design and procedures, and the analytical plan to test the study hypotheses. METHODS: This is a retrospective cohort study that examines associations between exposure to deprivation and threat and their hypothesized neurobiological mechanisms, how these neurobiological mechanisms link early adversity and psychopathology, and associations between unpredictability, reward learning, and psychopathology. The sample was a convenience sample of children (aged 4-7 years) and their families, identified through flyers, email blasts to listserves, school-based advertising, and involvement in community events. Data were collected during a home visit, a subsequent laboratory visit, and a final neuroimaging visit. Planned analyses include linear regression, path analyses, and functional magnetic resonance imaging analyses to explore the role of neural function in the association between early adversity and psychopathology. RESULTS: Participants (N=301) have been recruited into the study, and data collection has commenced. The expected results will be available in 2024. CONCLUSIONS: The findings of this study will help elucidate the neurobiological mechanisms by which early adversity increases risk for psychopathology in early childhood. This study represents the earliest test of an influential theory of biological embedding of early adversity. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59636.