Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward

Anxiety Clinical Trial

Official title:

Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405440
• Other study ID #: S62060
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2020
• Source: KU Leuven
• Contact: Laurence Claes, Prof. Dr.
• Phone: +32 16 32 61 33
• Email: laurence.claes[@]kuleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anxiety
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Behavioral avoidance task
Behavioral task able to measure avoidance actions, US-expectancy, and reward-related indexes in different learning times

Locations

Country	Name	City	State
Belgium	Psychiatry | UZ Leuven campus Gasthuisberg	Leuven
Belgium	University of KU Leuven, Faculteit Psychologie en Pedagogische Wetenschappen	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Bram Vervliet

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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