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Online Relapse Prevention Study (ORP)

Primary Purpose

Eating Disorders, Anorexia Nervosa, Bulimia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imaginal Exposure Condition
Writing and Thinking Condition
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Relapse Prevention, Treatment, Eating Disorder Symptoms, Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eating Anxiety Treatment Laboratory and ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Imaginal Exposure Condition

Writing and Thinking Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 23, 2021
Last Updated
August 17, 2023
Sponsor
University of Louisville
Collaborators
National Institute of Mental Health (NIMH), King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT04862247
Brief Title
Online Relapse Prevention Study
Acronym
ORP
Official Title
A Pilot Randomized Control Trial of a Relapse Prevention Online Exposure Protocol for Eating Disorders and Mechanisms of Change
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institute of Mental Health (NIMH), King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Anorexia Nervosa, Atypical, Other Specified Feeding or Eating Disorder
Keywords
Relapse Prevention, Treatment, Eating Disorder Symptoms, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaginal Exposure Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Writing and Thinking Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Imaginal Exposure Condition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Writing and Thinking Condition
Intervention Description
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 Outcome Measure Information:
Title
Rate of Eating Disorder Relapse
Description
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).
Time Frame
6-Month Follow-Up
Title
Change in Eating Disorder Symptoms using the EDE-Q
Description
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.
Time Frame
Up to 6-Month Follow-Up
Title
Re-admission Percentage
Description
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.
Time Frame
1 Month Follow Up and 6 Month Follow Up
Secondary Outcome Measure Information:
Title
Change in State Anxiety
Description
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.
Time Frame
Treatment Session 1 through 5
Title
Change in State Fear of Food
Description
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.
Time Frame
Treatment Session 2 through 5
Title
Change in Positive and Negative Affect
Description
State Positive and Negative Affect Schedule will be used to assess positive and negative affect at the beginning and end of each session.
Time Frame
Treatment Session 2 through 5
Title
Change in Eating Disorder Symptoms
Description
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.
Time Frame
Treatment Session 2 through 5
Title
Fear Extinction
Description
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.
Time Frame
Up to 6 Month Follow Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheri A Levinson, PhD
Phone
502-852-7710
Email
cheri.levinson@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Taylor E Penwell, B.A.
Email
taylor.penwell@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheri A Levinson, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eating Anxiety Treatment Laboratory and Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheri A Levinson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31735247
Citation
Farrell NR, Brosof LC, Vanzhula IA, Christian C, Bowie OR, Levinson CA. [Exploring Mechanisms of Action in Exposure-Based Cognitive Behavioral Therapy for Eating Disorders: The Role of Eating-Related Fears and Body-Related Safety Behaviors]. Behav Ther. 2019 Nov;50(6):1125-1135. doi: 10.1016/j.beth.2019.01.008. Epub 2019 Feb 12. French.
Results Reference
background
PubMed Identifier
29145095
Citation
Levinson CA, Brosof LC, Ma J, Fewell L, Lenze EJ. Fear of food prospectively predicts drive for thinness in an eating disorder sample recently discharged from intensive treatment. Eat Behav. 2017 Dec;27:45-51. doi: 10.1016/j.eatbeh.2017.11.004. Epub 2017 Nov 9.
Results Reference
background
PubMed Identifier
31317512
Citation
Levinson CA, Christian C, Vanzhula IA. Manipulating the theoretical framing of exposure therapy for eating disorders impacts clinicians' treatment preferences. Eat Weight Disord. 2020 Oct;25(5):1205-1212. doi: 10.1007/s40519-019-00751-3. Epub 2019 Jul 17.
Results Reference
background
PubMed Identifier
30392878
Citation
Murray SB, Strober M, Craske MG, Griffiths S, Levinson CA, Strigo IA. Fear as a translational mechanism in the psychopathology of anorexia nervosa. Neurosci Biobehav Rev. 2018 Dec;95:383-395. doi: 10.1016/j.neubiorev.2018.10.013. Epub 2018 Oct 28.
Results Reference
background
PubMed Identifier
28815659
Citation
Reilly EE, Anderson LM, Gorrell S, Schaumberg K, Anderson DA. Expanding exposure-based interventions for eating disorders. Int J Eat Disord. 2017 Oct;50(10):1137-1141. doi: 10.1002/eat.22761. Epub 2017 Aug 16.
Results Reference
background
PubMed Identifier
32794449
Citation
Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21.
Results Reference
background
PubMed Identifier
24691784
Citation
Levinson CA, Rapp J, Riley EN. Addressing the fear of fat: extending imaginal exposure therapy for anxiety disorders to anorexia nervosa. Eat Weight Disord. 2014 Dec;19(4):521-4. doi: 10.1007/s40519-014-0115-6. Epub 2014 Apr 2. No abstract available.
Results Reference
background
PubMed Identifier
20127936
Citation
Steinglass JE, Sysko R, Glasofer D, Albano AM, Simpson HB, Walsh BT. Rationale for the application of exposure and response prevention to the treatment of anorexia nervosa. Int J Eat Disord. 2011 Mar;44(2):134-41. doi: 10.1002/eat.20784.
Results Reference
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Online Relapse Prevention Study

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