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Completed

NCT Number: NCT04862247

Online Relapse Prevention Study

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.

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Key information

Conditions

Eating Disorders Anorexia Nervosa Anorexia Nervosa, Atypical Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Other Specified Feeding or Eating Disorder Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, 40292, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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).

  2. 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.

  3. 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

  1. Change in State Anxiety

    Time frame: Treatment Session 1 through 5

    Subjective Units of Distress(SUDS) is a valid and reliable behavioral measure of state anxiety used during each treatment session to measure anxiety and distress and will be collected before, during, and after each session. Additionally, the Brief State Anxiety Measure is a 6-item measure with acceptable reliability and validity and sensitivity to fluctuations in state anxiety levels and will be collected at the beginning and end of each session.

  2. Change in State Fear of Food

    Time frame: Treatment Session 2 through 5

    State Fear of Food Measure will be used to assess food anxiety, food avoidance, and feared concerns and will be collected at the beginning and end of each session.

  3. Change in Positive and Negative Affect

    Time frame: Treatment Session 2 through 5

    State Positive and Negative Affect Schedule will be used to assess positive and negative affect at the beginning and end of each session.

  4. Change in Eating Disorder Symptoms

    Time frame: Treatment Session 2 through 5

    Eating Disorder-15 is a 15-item measure of eating disorder cognitions and behaviors, which will be collected at the beginning of each treatment session.

  5. Fear Extinction

    Time frame: Up to 6 Month Follow Up

    FLARe is a validated smart-phone behavioral assessment of fear learning that will assess target engagement at baseline, post, and one and six month follow-ups.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • King's College London
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: ORP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2021
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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