Online Relapse Prevention Study

Anorexia Nervosa Clinical Trial

— ORP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862247
• Other study ID #: IRB#20.0626
• Secondary ID: 1R34MH124799-01
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: University of Louisville
• Contact: Cheri A Levinson, PhD
• Phone: 502-852-7710
• Email: cheri.levinson[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Eating Anxiety Treatment Laboratory and Clinic	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Louisville	King's College London, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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