MedPath

Online Relapse Prevention Study

Not Applicable
Active, not recruiting
Conditions
Bulimia Nervosa
Eating Disorders
Anorexia Nervosa
Anorexia Nervosa, Atypical
Other Specified Feeding or Eating Disorder
Interventions
Behavioral: Imaginal Exposure Condition
Behavioral: Writing and Thinking Condition
Registration Number
NCT04862247
Lead Sponsor
University of Louisville
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
130
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Imaginal Exposure ConditionImaginal Exposure ConditionParticipants 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 ConditionWriting and Thinking ConditionParticipants 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.
Primary Outcome Measures
NameTimeMethod
Re-admission Percentage1 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 Relapse6-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-QUp 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 Outcome Measures
NameTimeMethod
Change in Positive and Negative AffectTreatment 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.

Fear ExtinctionUp 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.

Change in Eating Disorder SymptomsTreatment 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.

Change in State AnxietyTreatment 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.

Change in State Fear of FoodTreatment 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.

Trial Locations

Locations (1)

Eating Anxiety Treatment Laboratory and Clinic

🇺🇸

Louisville, Kentucky, United States

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