Clinical trial NCT05195840: Personalized Treatment for Eating Disorders Versus CBT-E Trial
Official title: A Pilot Investigation of Network-Informed Personalized Treatment for Eating Disorders Versus Enhanced Cognitive Behavioral Therapy and Dynamic Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Eating Disorders
Keywords: eating disorder
treatment
anorexia nervosa
bulimia nervosa
binge eating disorder
atypical anorexia nervosa
therapy
other specified feeding and eating disorder
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-01-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinical Impairment using the Clinical Impairment Assessment
timeFrame: Up to 1-Month Follow-Up
measure: Change in Eating Disorder Symptoms using the Eating Disorder Examination Questionnaire
timeFrame: Up to 1-Month Follow-Up
measure: Change in Quality of Life using the Quality of Life Scale
timeFrame: Up to 1-Month Follow-Up
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Eating Anxiety Treatment Laboratory and Clinic
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Cheri A Levinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levinson CA, Williams BM. Eating disorder fear networks: Identification of central eating disorder fears. Int J Eat Disord. 2020 Dec;53(12):1960-1973. doi: 10.1002/eat.23382. Epub 2020 Sep 12.
citation: Levinson CA, Vanzhula I, Brosof LC. Longitudinal and personalized networks of eating disorder cognitions and behaviors: Targets for precision intervention a proof of concept study. Int J Eat Disord. 2018 Nov;51(11):1233-1243. doi: 10.1002/eat.22952. Epub 2018 Oct 6.
citation: Murphy R, Straebler S, Cooper Z, Fairburn CG. Cognitive behavioral therapy for eating disorders. Psychiatr Clin North Am. 2010 Sep;33(3):611-27. doi: 10.1016/j.psc.2010.04.004.
citation: Fairburn CG, Cooper Z, Shafran R. Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28. doi: 10.1016/s0005-7967(02)00088-8.