Clinical trial NCT05596799: Facing Eating Disorder Fears for Anorexia Nervosa
Official title: Facing Eating Disorder Fears for Anorexia Nervosa: a Virtual Relapse Prevention Program Targeted At Approach and Avoidance Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Anorexia Nervosa
Anorexia Nervosa in Remission
Keywords: therapy
eating disorder
anorexia nervosa
treatment
relapse prevention
virtual treatment
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-10-27
Enrollment: 70
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: FED-F is a modular treatment that enhances exposure therapy with psychoeducation and cognitive skills teaching how to face fears of (a) food, (b) weight gain, (c) interoception/body, and (d) social situations. The study goals are to (1) refine and test the acceptability and feasibility of FED-F treatment (Phase I), (2) test if this treatment outperforms treatment as usual (TAU) delivered post-acute treatment as adjunctive to stepdown specialty care (Phase II), and (3) to examine if treatment targets the hypothesized mechanism of action: approach behaviors (Phase II). These goals will lead to a highly deployable and accessible virtual treatment targeted at core AN mechanisms that predict relapse. Specific aims are to (1) refine FED-F into a fully virtual format with input from patients and stakeholders and collect preliminary data (N=10) on its feasibility and acceptability (Phase I), (2) conduct a small pilot RCT (randomized controlled trial) of FED-F (n=30) as compared to TAU (n=30; Phase II), and (3) examine if FED-F targets approach/avoidance behaviors and test if this mechanism is associated with clinical outcomes (Phase II).


Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Meets criteria for DSM-5 defined AN, AN partial remission, or AN full remission, Atypical Anorexia Nervosa (AAN), AAN partial remission, or AAN full remission
* Has been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months

Exclusion Criteria:

* Under 18
* Over 65
* Does not meet criteria for DSM-5 defined AN, AN partial-remission, or AN full-remission
* High and active Suicidality
* Active Mania
* Active psychosis
* Medically Compromised Status including extremely low weight (less than or equal to 75% median BMI for age, sex, and height)
* Does not meet criteria for DSM-5 defined AN, AN partial remission, or AN full remission, AAN, AAN partial remission, or AAN full remission
* Has not been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months

Primary outcomes:
measure: Change in Structured Clinical Interview for DSM-5 (SCID-5)
timeFrame: Up to 2-month follow-up
measure: Change in Eating Disorder Fear Inventory (EFI)
timeFrame: Up to 2-month follow-up
measure: Change in Treatment Interview
timeFrame: Up to 2-month follow-up
measure: Change in Eating Disorder Examination Questionnaire 6.0 (EDE-Q)
timeFrame: Up to 2-month follow-up
measure: Change in Fear of Food Measure (FOFM)
timeFrame: Up to 2-month follow-up
measure: Change in Eating Disorder Fear Questionnaire (EFQ)
timeFrame: Up to 2-month follow-up
Secondary outcomes:
measure: Change in Behavioral Approach Task
timeFrame: Up to 2-month follow-up
measure: Change in Behavioral Inhibition System/Behavioral Activation System (BIS/BAS)
timeFrame: Up to 2-month follow-up
measure: Change in Subjective Units of Distress (SUDS)
timeFrame: Up to session 12
measure: Change in State Fear of Food Measure
timeFrame: Up to Session 12
measure: Change in Mobile Assessment of Approach and Avoidance
timeFrame: Up to Session 12
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Eating Anxiety Laboratory and Clinic
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Cheri A Levinson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
citation: Carl JR, Miller CB, Henry AL, Davis ML, Stott R, Smits JAJ, Emsley R, Gu J, Shin O, Otto MW, Craske MG, Saunders KEA, Goodwin GM, Espie CA. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depress Anxiety. 2020 Dec;37(12):1168-1178. doi: 10.1002/da.23079. Epub 2020 Jul 29.
citation: Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21.
citation: Farrell NR, Brosof LC, Vanzhula IA, Christian C, Bowie OR, Levinson CA. [Exploring Mechanisms of Action in Exposure-Based Cognitive Behavioral Therapy for Eating Disorders: The Role of Eating-Related Fears and Body-Related Safety Behaviors]. Behav Ther. 2019 Nov;50(6):1125-1135. doi: 10.1016/j.beth.2019.01.008. Epub 2019 Feb 12. French.
citation: Butler RM, Heimberg RG. Exposure therapy for eating disorders: A systematic review. Clin Psychol Rev. 2020 Jun;78:101851. doi: 10.1016/j.cpr.2020.101851. Epub 2020 Mar 21.