---
title: Online Relapse Prevention Study
nct_id: NCT04862247
overall_status: COMPLETED
phase: NA
sponsor: University of Louisville
study_type: INTERVENTIONAL
primary_condition: Eating Disorders
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04862247.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04862247"
ct_last_update_post_date: 2025-03-30
last_seen_at: "2026-05-12T07:30:31.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Online Relapse Prevention Study

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

**NCT ID:** [NCT04862247](https://clinicaltrials.gov/study/NCT04862247)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 130
- **Lead Sponsor:** University of Louisville
- **Collaborators:** National Institute of Mental Health (NIMH), King's College London
- **Conditions:** Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical, Other Specified Feeding or Eating Disorder
- **Start Date:** 2021-06-04
- **Completion Date:** 2025-02-01
- **CT.gov Last Update:** 2025-03-30

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Imaginal Exposure Condition** (EXPERIMENTAL) — Participants will complete one phone session including education about the treatment followed by four online sessions of imaginal exposure across a one month time period. Each session is separated by 1 week.
- **Writing and Thinking Condition** (ACTIVE_COMPARATOR) — Participants will complete one phone session including education about the treatment followed by four online sessions of a writing and thinking intervention across a one month time period. Each session is separated by 1 week.

## Interventions

- **Imaginal Exposure Condition** (BEHAVIORAL) — Participants will be asked to think and write about an eating related fear or anxiety. Specifically, they will be asked to spend 20-30 minutes writing about a specific fear or anxiety they have, then another 20-35 minutes re-reading and imagining that what they have written is happening.
- **Writing and Thinking Condition** (BEHAVIORAL) — Participants will be asked to think and write about their eating disorder using specific prompts designed to help them process their eating disorder. Specifically, they will be asked to spend 20-30 minutes writing their eating disorder, then another 20-35 minutes re-reading what they wrote.

## Primary Outcomes

- **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.
- **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.

## Secondary Outcomes

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

## Locations (1)

- Eating Anxiety Treatment Laboratory and Clinic, Louisville, Kentucky, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.eating anxiety treatment laboratory and clinic|louisville|kentucky|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04862247.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04862247*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*