Online Relapse Prevention Study

NCT ID: NCT04862247

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-04

Study Completion Date

2025-02-01

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Imaginal Exposure Condition

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Writing and Thinking Condition

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Cheri Levinson

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheri A Levinson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31735247 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29145095 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31317512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30392878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28815659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32794449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24691784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20127936 (View on PubMed)

Other Identifiers

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1R34MH124799-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB#20.0626

Identifier Type: -

Identifier Source: org_study_id

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