Skip to main content
Clinical Trials/NCT04862247
NCT04862247
Completed
N/A

A Pilot Randomized Control Trial of a Relapse Prevention Online Exposure Protocol for Eating Disorders and Mechanisms of Change

University of Louisville1 site in 1 country130 target enrollmentJune 4, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Eating Disorders
Sponsor
University of Louisville
Enrollment
130
Locations
1
Primary Endpoint
Re-admission Percentage
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. The second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ED outcomes (e.g., ED symptoms, fears). The investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ED outcomes. The investigators also plan to test if baseline differences in fear conditioning relate to change in ED outcomes across treatment.

Registry
clinicaltrials.gov
Start Date
June 4, 2021
End Date
February 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cheri Levinson

Director

University of Louisville

Eligibility Criteria

Inclusion Criteria

  • over the age of 18
  • discharged from intensive treatment within the last four months (inpatient, residential, partial hospital/day program, intensive outpatient program)
  • currently meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa

Exclusion Criteria

  • high and active suicidality, psychosis, mania, or medical compromised status will be excluded, as these comorbidities would make it difficult to complete study procedures
  • under the age of 18
  • does not meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa.
  • discharged from intensive treatment more than four months ago

Outcomes

Primary Outcomes

Re-admission Percentage

Time Frame: 1 Month Follow Up and 6 Month Follow Up

Using the Treatment Interview, we will assess all current and past treatment experiences, dates of treatment, and primary type of treatment. Re-admission will be assessed at follow up timepoints and defined as re-entry into a more intensive treatment setting.

Rate of Eating Disorder Relapse

Time Frame: 6-Month Follow-Up

First, the investigators will define relapse as moving from one stage of remission to another (e.g., remission to partial remission or partial remission to currently ill). Second, the investigators will define relapse as re-entry into a more intensive treatment setting (e.g., moving from outpatient to partial hospitalization).

Change in Eating Disorder Symptoms using the EDE-Q

Time Frame: Up to 6-Month Follow-Up

The Eating Disorder Examination Questionnaire (EDEQ), a self-reported measure, is assessed at multiple time points throughout the duration of the study and is used to examine the attitudes and behaviors in individuals with eating disorder symptoms.

Secondary Outcomes

  • Change in Positive and Negative Affect(Treatment Session 2 through 5)
  • Fear Extinction(Up to 6 Month Follow Up)
  • Change in Eating Disorder Symptoms(Treatment Session 2 through 5)
  • Change in State Anxiety(Treatment Session 1 through 5)
  • Change in State Fear of Food(Treatment Session 2 through 5)

Study Sites (1)

Loading locations...

Similar Trials