Eating DisordersNCT04405440
Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward
An observational study of Eating Disorders and Anxiety, run by Bram Vervliet at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Anxiety, Anorexia Nervosa
- What is being tested?
- Behavioral avoidance task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 May 2019to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The anorexia patients are recruited from a primary care clinic. Healthy controls are recruited from the general population
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Bram Vervliet, Prof. Dr. contact
Belgium2 sites, 2 recruiting
- Recruiting
Psychiatry | UZ Leuven campus Gasthuisberg
Leuven, 3000
Laurence Claes, Prof. Dr., laurence.claes@kuleuven.be
- Recruiting
University of KU Leuven, Faculteit Psychologie en Pedagogische Wetenschappen
Leuven, 3000
Laurence Claes, Prof. Dr., 32 16 32 61 33, laurence.claes@kuleuven.be
Bram Vervliet, Prof. Dr., bram.vervliet@kuleuven.be
About this study
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.
Read the 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.
- Conditions
- Eating Disorders, Anxiety, Anorexia Nervosa
- Being tested
- Behavioral avoidance task
- Medical subject headings
- Feeding and Eating Disorders, Anxiety Disorders, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral avoidance taskBehavioural
Behavioral task able to measure avoidance actions, US-expectancy, and reward-related indexes in different learning times
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral avoidance task | |
| 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 Receives: Behavioral: Behavioral avoidance task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 May 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bram Vervliet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bram Vervliet, KU Leuven
- Investigators
- Laurence Claes, Prof. Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405440
- Sponsor's protocol ID
- S62060
- Status last verified
- May 2020
- First submitted
- 28 Nov 2019
- Last updated
- 28 May 2020
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15569892Godart 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.
PubMed 10713801Koskina 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.
PubMed 23201859Murray 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.
PubMed 27463780Murray 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.
PubMed 30392878Wierenga 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.
PubMed 25481622Park 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.
PubMed 25151600
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excessive Avoidance Behaviors in Anorexia Nervosa: the Role of Reward
- ClinicalTrials.gov ID
- NCT04405440
- Acronym / sponsor ID
- S62060
- Conditions
- Eating Disorders, Anxiety, Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bram VervlietUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Behavioral: Behavioral avoidance taskThe healthy control group will perform a well-validated avoidance (behavioral) task and will fill in some questionnaires about eating behaviors, emotions, and feelings. |
| Anorexia Nervosa patients | – | Behavioral: Behavioral avoidance taskAs the healthy controls, the participants of the anorexia nervosa group will perform the same behavioral task and will fill in the same questionnaires |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The anorexia patients are recruited from a primary care clinic. Healthy controls are recruited from the general population
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral avoidance taskBehavioral task able to measure avoidance actions, US-expectancy, and reward-related indexes in different learning times | Behavioural | Anorexia Nervosa patients, Healthy controls |
Primary outcome
Button clicks during a red cue will be recorded as a measure of avoidance (binary response)
Time frame: through study completion, an average of 1 year
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.
Relief pleasantness ratings (Visual Analog Scale, from neutral [0] to very pleasant [100])
Time frame: through study completion, an average of 1 year
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.
3 secondary outcomes
US-Expectancy ratings (Likert scale from 0:no picture to 10:certainly a picture)
Time frame: through study completion, an average of 1 year
Eating Disorders Inventory [EDI]
Time frame: through study completion, an average of 1 year
Distress Tolerance Scale [DTS]
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Background: PubMed 15569892Kaye 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.
- Background: PubMed 10713801Godart 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.
- Background: PubMed 23201859Koskina 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.
- Background: PubMed 27463780Murray 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.
- Background: PubMed 30392878Murray 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.
- Background: PubMed 25481622Wierenga 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.
- Background: PubMed 25151600Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bram Vervliet, Prof. Dr. contact
Laurence Claes, Prof. Dr. principal investigator
KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders and Anxiety, run by Bram Vervliet at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Claes, Prof. Dr. (+32 16 32 61 33, laurence.claes@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Button clicks during a red cue will be recorded as a measure of avoidance (binary response) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04405440, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.