Personalized Treatment for Eating Disorders Versus CBT-E Trial

Study Overview
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Brief Summary
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The scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: CBT-E). The study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of NA-PT versus CBT-E and (2) to test if network-identified precision targets are the mechanism of change. These goals will ultimately lead to the very first personalized treatment for ED and can be extended to additional psychiatric illnesses. Specific aims are (1) To collect preliminary data on the feasibility and acceptability of the randomization of NA-PT (n=40) for EDs versus CBT-E (n=40), (2) To test the initial clinical efficacy of NA-PT versus CBT-E on clinical outcomes (e.g., ED symptoms, body mass index, quality of life) and (3) To examine if changes in NA-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.

Official Title
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A Pilot Investigation of Network-Informed Personalized Treatment for Eating Disorders Versus Enhanced Cognitive Behavioral Therapy and Dynamic Mechanisms of Change

Conditions
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Eating Disorders

Intervention / Treatment
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* Behavioral: Personalized Treatment for Eating Disorders
* Behavioral: Cognitive Behavioral Therapy for Eating Disorders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Meets criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN) Not currently receiving psychological treatment focused on ED Exclusion Criteria: Under 18 Over 65 Does not meet criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN) High and active Suicidality Active Mania Medically Compromised Status including extremely low weight - less than or equal to 75% median BMI for age, sex, and height Simultaneous psychological treatment focused on ED

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Treatment for Eating Disorders<br>Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of personalized treatment for eating disorders. | Behavioral: Personalized Treatment for Eating Disorders<br>* The first three sessions consist of diagnosis and general psychoeducation on EDs and treatment for ED. After mobile-assessment is complete, Session 4 includes psychoeducation on the network-informed model of personalized treatment and 14 sessions (sessions 5-19) are focused on the top three targets (4-5 sessions per target). Session 20 is a termination and conclusion session.<br>|
| Active Comparator: Cognitive Behavioral Therapy for Eating Disorders<br>Participants will complete 3 sessions of education about the treatment while completing 2 weeks of mobile application questions. After completion of treatment education and mobile application questions, participants will complete 17 sessions of Cognitive Behavioral Therapy for Eating Disorders. | Behavioral: Cognitive Behavioral Therapy for Eating Disorders<br>* The first three sessions consist of diagnosis and general psychoeducation on EDs and treatment for ED. After mobile-assessment is complete, Session 4 consists of food monitoring, addressing irregular eating, challenging thoughts, making adaptive behavioral changes, and relapse prevention. Session 20 is a termination and conclusion session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Impairment using the Clinical Impairment Assessment | The Clinical Impairment Assessment (CIA), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine the severity of psychosocial impairment caused by eating disorders. The scores range from 0 to 64 with higher scores indicating more impairment. | Up to 1-Month Follow-Up | 
| Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire | The Eating Disorder Examination Questionnaire (EDE-Q), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine attitudes and behaviors in individuals with eating disorder symptoms. The scores range from 0-6 with higher scores indicating higher severity of eating disorder symptoms. | Up to 1-Month Follow-Up | 
| Change in Quality of Life using the Quality of Life Scale | The Quality of Life Scale (QOLS), a self report measure, is assessed at multiple time points throughout the duration of the study and is used to examine various domains of quality of life. Scores range from 16 to 112 with higher scores indicating better quality of life. | Up to 1-Month Follow-Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eating disorder, treatment, anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia nervosa, therapy, other specified feeding and eating disorder