Facing Eating Disorder Fears for Anorexia Nervosa: a Virtual Relapse Prevention Program Targeted At Approach and Avoidance Behaviors

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Kentucky
Eating Anxiety Laboratory and Clinic
RECRUITING
Louisville
Contact Information
Primary
Cheri A Levinson, Ph.D.
cheri.levinson@louisville.edu
502-852-7710
Backup
Abigail M McCarthy, B.S.
abigail.mccarthy.1@louisville.edu
502-230-1844
Time Frame
Start Date: 2022-12-08
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 70
Treatments
Experimental: Facing Eating Disorder Fears Condition
Participants will complete 1 session of education about the treatment. After completion of treatment education and baseline questionnaires, participants will complete sessions 2 through 12 of virtual treatment for anorexia nervosa and mobile assessments.
No_intervention: Treatment as Usual
Participants will complete baseline measures, mobile assessments and treatment as usual.
Related Therapeutic Areas
Sponsors
Leads: University of Louisville
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov