Online Relapse Prevention Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical, Other Specified Feeding or Eating Disorder

Intervention / Treatment
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* Behavioral: Imaginal Exposure Condition
* Behavioral: Writing and Thinking Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaginal Exposure Condition<br>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. | Behavioral: Imaginal Exposure Condition<br>* 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.<br>|
| Active Comparator: Writing and Thinking Condition<br>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. | Behavioral: Writing and Thinking Condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Eating Disorder Relapse | 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). | 6-Month Follow-Up | 
| Change in Eating Disorder Symptoms using the EDE-Q | 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. | Up to 6-Month Follow-Up | 
| Re-admission Percentage | 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. | 1 Month Follow Up and 6 Month Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in State Anxiety | 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. | Treatment Session 1 through 5 | 
| Change in State Fear of Food | 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. | Treatment Session 2 through 5 | 
| Change in Positive and Negative Affect | State Positive and Negative Affect Schedule will be used to assess positive and negative affect at the beginning and end of each session. | Treatment Session 2 through 5 | 
| Change in Eating Disorder Symptoms | 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. | Treatment Session 2 through 5 | 
| Fear Extinction | 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. | Up to 6 Month Follow Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse Prevention, Treatment, Eating Disorder Symptoms, Therapy