Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward

NCT ID: NCT04405440

Last Updated: 2020-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eating Disorders Anxiety Anorexia Nervosa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 avoidance task

Intervention Type BEHAVIORAL

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 avoidance task

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral avoidance task

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bram Vervliet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bram Vervliet

Principal Investigator Prof. Dr. Bram Vervliet

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurence Claes, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Psychiatry | UZ Leuven campus Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

University of KU Leuven, Faculteit Psychologie en Pedagogische Wetenschappen

Leuven, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laurence Claes, Prof. Dr.

Role: CONTACT

+32 16 32 61 33

Bram Vervliet, Prof. Dr.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Laurence Claes, Prof. Dr.

Role: primary

Laurence Claes, Prof. Dr.

Role: primary

32 16 32 61 33

Bram Vervliet, Prof. Dr.

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15569892 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10713801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23201859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27463780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30392878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25481622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25151600 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S62060

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.