RECRUITING

Facing Eating Disorder Fears for Anorexia Nervosa

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-12-08
Study Completion:2025-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05596799

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-65
  2. * 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
  3. * Has been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months
  1. * Under 18
  2. * Over 65
  3. * Does not meet criteria for DSM-5 defined AN, AN partial-remission, or AN full-remission
  4. * High and active Suicidality
  5. * Active Mania
  6. * Active psychosis
  7. * Medically Compromised Status including extremely low weight (less than or equal to 75% median BMI for age, sex, and height)
  8. * Does not meet criteria for DSM-5 defined AN, AN partial remission, or AN full remission, AAN, AAN partial remission, or AAN full remission
  9. * Has not been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months

Contacts and Locations

Study Contact

Cheri A Levinson, Ph.D.
CONTACT
502-852-7710
cheri.levinson@louisville.edu
Abigail M McCarthy, B.S.
CONTACT
502-230-1844
abigail.mccarthy.1@louisville.edu

Principal Investigator

Cheri A Levinson, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Louisville

Study Locations (Sites)

Eating Anxiety Laboratory and Clinic
Louisville, Kentucky, 40205
United States

Collaborators and Investigators

Sponsor: University of Louisville

  • Cheri A Levinson, Ph.D., PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-08
Study Completion Date2025-02-01

Study Record Updates

Study Start Date2022-12-08
Study Completion Date2025-02-01

Terms related to this study

Keywords Provided by Researchers

  • therapy
  • eating disorder
  • anorexia nervosa
  • treatment
  • relapse prevention
  • virtual treatment

Additional Relevant MeSH Terms

  • Eating Disorders
  • Anorexia Nervosa
  • Anorexia Nervosa in Remission