Stress and Neurofeedback in Anorexia Nervosa

NCT05834816 | Terminated

• 1 other identifier: 805807
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Anorexia nervosa (AN) and atypical AN (AAN) are severe psychiatric illnesses associated with high disease burden including high treatment costs and excessive mortality rates. Primary characteristics of AN and AAN are food restriction, associated fear of weight gain, and a disturbance in how one's body weight or shape is experienced.The underlying neural mechanisms for the core illness behaviors of food restriction and body size overestimation in anorexia nervosa and atypical anorexia nervosa are not well understood. This project will use neurofeedback and advanced psychophysical methods to assess and moderate the neural and behavioral responses to stress and relate those results to the naturalistic environment. The results will guide the development of novel interventions.

Conditions

Anorexia Nervosa; Atypical Anorexia Nervosa

Outcome Measures

Primary Outcomes (2)

• Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a taste reward task

  Activation in the brain during a taste reward task will be measured using functional MRI (fMRI) after a neutral and stressful task.

  Difference in brain response between the neutral and stress condition, up to 9 days

• Functional Magnetic Resonance Imaging (fMRI) brain activation in response to stress during a body size estimation task

  Activation in the brain during a body size estimation task will be measured using functional MRI (fMRI) after a neutral and stressful task.

  Difference in brain response between the neutral and stress condition, up to 9 days

Secondary Outcomes (1)

• Ecological Momentary Assessment (EMA)

  Up to 9 days

Study Arms (1)

Behavioral

EXPERIMENTAL

Negative Affect Task

Behavioral: Negative Affect Task

Interventions

Negative Affect Task BEHAVIORAL

fMRI stress task

Also known as: Functional Magnetic Resonance Brain Imaging Stress Task

Behavioral

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Controls (HC)
• Individuals aged 18-45 years
• Healthy body weight between 90 and 110 % average body weight since puberty.
• Regular monthly menstrual cycle (if applicable)
• Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
• All ethnic backgrounds
• English is primary language spoken
• Anorexia Nervosa (AN)
• Age 18-45 years old
• Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
• All ethnic backgrounds
• Current diagnosis of anorexia nervosa, including being underweight, will have a severe fear of weight gain, body image distortion and absence of the menstrual cycle over three consecutive months.
• English is primary language spoken
• Atypical Anorexia Nervosa (AAN)
• Age 18-45 years old

You may not qualify if:

• Healthy Controls (HC)
• Current pregnancy or breast feeding within last 3 months
• First degree relative with current or past eating disorder
• Psychiatric Medication use such as selective serotonin reuptake inhibitors (SSRIs), atypical antipsychotics, etc.
• Past or present Axis I psychiatric disorder including substance or alcohol use disorder as determined through structured clinical interview
• History of significant head trauma
• Indication of intellectual disability or autism spectrum disorder
• Major Medical illness that requires medication or have significant impact on subject's life such as: diabetes, Alzheimer's disease or dementia, stroke, learning disability, mobility disorders, cancer, high blood pressure, etc. (to be determined through biological screening form and interview with principal investigator (PI)
• Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence
• Contraindications to magnetic resonance imaging (MRI) including metal implants or braces (as determined through fMRI screening form)
• Anorexia Nervosa (AN)
• Pregnancy or breast feeding within last 3 months
• Lifetime history of bipolar I disorder or psychosis
• Current substance abuse or dependence in the past 3 months
• Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92121, United States

Location

Related Publications (4)

• Frank GKW, Shott ME, Stoddard J, Swindle S, Pryor TL. Association of Brain Reward Response With Body Mass Index and Ventral Striatal-Hypothalamic Circuitry Among Young Women With Eating Disorders. JAMA Psychiatry. 2021 Oct 1;78(10):1123-1133. doi: 10.1001/jamapsychiatry.2021.1580.

  PMID: 34190963 BACKGROUND

• Gardner RM, Bokenkamp ED. The role of sensory and nonsensory factors in body size estimations of eating disorder subjects. J Clin Psychol. 1996 Jan;52(1):3-15. doi: 10.1002/(SICI)1097-4679(199601)52:13.0.CO;2-X.

  PMID: 8682909 BACKGROUND

• Gardner RM, Boice R. A computer program for measuring body size distortion and body dissatisfaction. Behav Res Methods Instrum Comput. 2004 Feb;36(1):89-95. doi: 10.3758/bf03195553.

  PMID: 15190703 BACKGROUND

• Misaki M, Phillips R, Zotev V, Wong CK, Wurfel BE, Krueger F, Feldner M, Bodurka J. Real-time fMRI amygdala neurofeedback positive emotional training normalized resting-state functional connectivity in combat veterans with and without PTSD: a connectome-wide investigation. Neuroimage Clin. 2018 Aug 19;20:543-555. doi: 10.1016/j.nicl.2018.08.025. eCollection 2018.

  PMID: 30175041 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Guido Frank, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 28, 2023
• Study Start: April 26, 2023
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)