Clinical trial NCT04405440: Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward
Official title: Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eating Disorders
Anxiety
Anorexia Nervosa
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Button clicks during a red cue will be recorded as a measure of avoidance (binary response)
timeFrame: through study completion, an average of 1 year
measure: Relief pleasantness ratings (Visual Analog Scale, from neutral [0] to very pleasant [100])
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: US-Expectancy ratings (Likert scale from 0:no picture to 10:certainly a picture)
timeFrame: through study completion, an average of 1 year
measure: Eating Disorders Inventory [EDI]
timeFrame: through study completion, an average of 1 year
measure: Distress Tolerance Scale [DTS]
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Psychiatry | UZ Leuven campus Gasthuisberg
city: Leuven
country: Belgium
facility: University of KU Leuven, Faculteit Psychologie en Pedagogische Wetenschappen
Study officials:
affiliation: KU Leuven
name: Laurence Claes, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1176/appi.ajp.161.12.2215.
citation: 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.
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.
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. No abstract available.
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: 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.
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.