Clinical trial NCT04862247: Online Relapse Prevention Study
Official title: A Pilot Randomized Control Trial of a Relapse Prevention Online Exposure Protocol for Eating Disorders and Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Anorexia Nervosa, Atypical
Other Specified Feeding or Eating Disorder
Keywords: Relapse Prevention
Treatment
Eating Disorder Symptoms
Therapy
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: King's College London
First posted: 2021-04-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of Eating Disorder Relapse
timeFrame: 6-Month Follow-Up
measure: Change in Eating Disorder Symptoms using the EDE-Q
timeFrame: Up to 6-Month Follow-Up
measure: Re-admission Percentage
timeFrame: 1 Month Follow Up and 6 Month Follow Up
Secondary outcomes:
measure: Change in State Anxiety
timeFrame: Treatment Session 1 through 5
measure: Change in State Fear of Food
timeFrame: Treatment Session 2 through 5
measure: Change in Positive and Negative Affect
timeFrame: Treatment Session 2 through 5
measure: Change in Eating Disorder Symptoms
timeFrame: Treatment Session 2 through 5
measure: Fear Extinction
timeFrame: Up to 6 Month Follow Up
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Eating Anxiety Treatment Laboratory and Clinic
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Cheri A Levinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.