Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward

This study investigates excessive avoidance behaviors in patients with a diagnosis of Anorexia Nervosa (AN) compared to a healthy control group. The study further examines the role of reward (relief) as a putative factor in maintaining excessive avoidance behaviors in AN.

Study Overview

• Status: Unknown
• Conditions: Anorexia Nervosa; Anxiety; Eating Disorders
• Intervention / Treatment: Behavioral: Behavioral avoidance task

Detailed Description

Anorexia Nervosa (AN) is a life-threatening mental disease with a disappointing treatment outcome. Fear of weight gain and diet restrictions are considered the core symptoms of AN. Although from a diagnostic perspective AN is conceptualized as an eating-related disorder connected to an extremely low Body Mass Index (BMI) and body image distortion, AN might represent a specific phenotype of anxiety disorders characterized by tenacious avoidance behaviors, especially the restrictive subtype. To date, avoidance in AN is often investigated as a general personality trait (e.g. harm avoidance) but poorly examined in its behavioral form (which is life-threatening, such as food-avoidance). Hence, the investigators will perform a systematic investigation of excessive avoidance behaviors within a laboratory setting. Within a learning perspective, the investigators will investigate excessive avoidance in a group of 30 AN patients and 30 healthy volunteers. To achieve this, a well-validated avoidance paradigm will be used. Most critically, the investigators will examine whether patients with a diagnosis of anorexia nervosa show persistent avoidance behaviors compared to a control group. Additionally, the investigators will examine if, in the anorexia group, higher subjective relief to successful omissions of negative events during avoidance learning predicts persistent (excessive) avoidance behaviors after fear extinction.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Laurence Claes, Prof. Dr.; Phone Number: +32 16 32 61 33; Email: laurence.claes@kuleuven.be
• Study Contact Backup: Name: Bram Vervliet, Prof. Dr.; Email: bram.vervliet@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Psychiatry | UZ Leuven campus Gasthuisberg
    • Contact: Laurence Claes, Prof. Dr.; Email: laurence.claes@kuleuven.be
  • Leuven, Belgium, 3000
    • Recruiting
    • University of KU Leuven, Faculteit Psychologie en Pedagogische Wetenschappen
    • Contact: Bram Vervliet, Prof. Dr.; Email: bram.vervliet@kuleuven.be
    • Contact: Laurence Claes, Prof. Dr.; Phone Number: 32 16 32 61 33; Email: laurence.claes@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The anorexia patients are recruited from a primary care clinic. Healthy controls are recruited from the general population

Description

Inclusion Criteria:

• For the AN group, patients need to be physically strong and sufficiently emotionally stable
• For the healthy group, the investigators will recruit participants without a previous or current history of psychiatric, cardiovascular, neurological or other relevant disorder

Exclusion Criteria:

• For the AN group, the investigators will exclude patients who are insufficiently emotionally stable and/or physically weak to participate in the study as estimated by the treating physicians of the units on which the patients are admitted
• Insufficient verbal skills to understand the questionnaires and the computer task
• Participants who are pregnant or breastfeeding

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls; The healthy control group will perform a well-validated avoidance (behavioral) task and will fill in some questionnaires about eating behaviors, emotions, and feelings.	Behavioral: Behavioral avoidance task; Behavioral task able to measure avoidance actions, US-expectancy, and reward-related indexes in different learning times
Anorexia Nervosa patients; As the healthy controls, the participants of the anorexia nervosa group will perform the same behavioral task and will fill in the same questionnaires	Behavioral: Behavioral avoidance task; Behavioral task able to measure avoidance actions, US-expectancy, and reward-related indexes in different learning times

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Button clicks during a red cue will be recorded as a measure of avoidance (binary response)	To investigate whether, compared to healthy controls, individuals with a diagnosis of anorexia nervosa show excessive avoidance behaviors (frequent clicking to prevent the aversive stimulus). Repeated measure ANOVA (analysis of variance) will be employed to evaluate differences between groups. If data will violate the assumption of normality, mixed or generalize methods will be used.	through study completion, an average of 1 year
Relief pleasantness ratings (Visual Analog Scale, from neutral [0] to very pleasant [100])	To investigate whether, compared to healthy controls, individuals with a diagnosis of anorexia nervosa show higher relief pleasantness during the omission of the aversive stimuli. The investigators will also test if such responses predict a return in avoidance behaviors (button click) after fear has been extinguished. Repeated measure ANOVA (analysis of variance) and multiple linear regressions will be employed to evaluate differences between groups. If data will violate the assumption of normality mixed or generalize methods will be used.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
US-Expectancy ratings (Likert scale from 0:no picture to 10:certainly a picture)	To investigate whether, compared to healthy controls, individuals with a diagnosis of anorexia nervosa show higher US-expectancies during both avoidance learning and fear extinction learning. Repeated measure ANOVA (analysis of variance) will be employed to evaluate differences between groups. If data will violate the assumption of normality mixed or generalize methods will be used.	through study completion, an average of 1 year
Eating Disorders Inventory [EDI]	Higher scores at the EDI, and especially to the drive for thinness subscale, correlate with higher avoidance actions.	through study completion, an average of 1 year
Distress Tolerance Scale [DTS]	Lower scores at the DTS correlate with higher relief and higher avoidance actions	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Bram Vervliet
• Investigators: Principal Investigator: Laurence Claes, Prof. Dr., KU Leuven

Publications and helpful links

General Publications

• Kaye WH, Bulik CM, Thornton L, Barbarich N, Masters K. Comorbidity of anxiety disorders with anorexia and bulimia nervosa. Am J Psychiatry. 2004 Dec;161(12):2215-21. doi: 10.1176/appi.ajp.161.12.2215.
• Godart NT, Flament MF, Lecrubier Y, Jeammet P. Anxiety disorders in anorexia nervosa and bulimia nervosa: co-morbidity and chronology of appearance. Eur Psychiatry. 2000 Feb;15(1):38-45. doi: 10.1016/s0924-9338(00)00212-1.
• Koskina A, Campbell IC, Schmidt U. Exposure therapy in eating disorders revisited. Neurosci Biobehav Rev. 2013 Feb;37(2):193-208. doi: 10.1016/j.neubiorev.2012.11.010. Epub 2012 Nov 29.
• Murray SB, Loeb KL, Le Grange D. Dissecting the Core Fear in Anorexia Nervosa: Can We Optimize Treatment Mechanisms? JAMA Psychiatry. 2016 Sep 1;73(9):891-2. doi: 10.1001/jamapsychiatry.2016.1623. No abstract available.
• 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.
• Wierenga CE, Bischoff-Grethe A, Melrose AJ, Irvine Z, Torres L, Bailer UF, Simmons A, Fudge JL, McClure SM, Ely A, Kaye WH. Hunger does not motivate reward in women remitted from anorexia nervosa. Biol Psychiatry. 2015 Apr 1;77(7):642-52. doi: 10.1016/j.biopsych.2014.09.024. Epub 2014 Oct 22.
• Park RJ, Godier LR, Cowdrey FA. Hungry for reward: How can neuroscience inform the development of treatment for Anorexia Nervosa? Behav Res Ther. 2014 Nov;62:47-59. doi: 10.1016/j.brat.2014.07.007. Epub 2014 Jul 26.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (ACTUAL): May 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders
• Other Study ID Numbers: S62060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No