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Online Relapse Prevention Study (ORP)

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ClinicalTrials.gov Identifier: NCT04862247
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : April 11, 2022
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
King's College London
Information provided by (Responsible Party):
Cheri Levinson, University of Louisville

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eating Disorders Anorexia Nervosa Bulimia Nervosa Anorexia Nervosa, Atypical Other Specified Feeding or Eating Disorder Behavioral: Imaginal Exposure Condition Behavioral: Writing and Thinking Condition Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Control Trial of a Relapse Prevention Online Exposure Protocol for Eating Disorders and Mechanisms of Change
Actual Study Start Date : June 4, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Imaginal Exposure Condition
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
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.
Active Comparator: Writing and Thinking Condition
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
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over the age of 18
  • discharged from intensive treatment within the last month (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 a month ago
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862247


Contacts
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Contact: Cheri A Levinson, PhD 502-852-7710 cheri.levinson@louisville.edu
Contact: Taylor E Gardner, B.A. taylor.gardner.1@louisville.edu

Locations
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United States, Kentucky
Eating Anxiety Treatment Laboratory and Clinic Recruiting
Louisville, Kentucky, United States, 40292
Contact: Cheri A Levinson, PhD         
Sponsors and Collaborators
University of Louisville
National Institute of Mental Health (NIMH)
King's College London
Investigators
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Principal Investigator: Cheri A Levinson, PhD University of Louisville
More Information
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Publications:

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Responsible Party: Cheri Levinson, Director, University of Louisville
ClinicalTrials.gov Identifier: NCT04862247    
Other Study ID Numbers: IRB#20.0626
1R34MH124799-01 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheri Levinson, University of Louisville:
Relapse Prevention
Treatment
Eating Disorder Symptoms
Therapy
Additional relevant MeSH terms:
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Disease
Recurrence
Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
 Bulimia Nervosa
Pathologic Processes
Disease Attributes
Mental Disorders
Signs and Symptoms, Digestive
Hyperphagia