Actively Recruiting

Phase Not Applicable
Age: 13Years - 50Years
FEMALE
NCT06332963

Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

Led by Laureate Institute for Brain Research, Inc. · Updated on 2025-09-26

102

Participants Needed

1

Research Sites

241 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored.

CONDITIONS

Official Title

Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

Who Can Participate

Age: 13Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary diagnosis of anorexia nervosa
  • Photographic Figure Rating Scale (PFRS) body dissatisfaction score greater than or equal to 1
  • Eating Disorder Examination Questionnaire (EDE-Q6) Shape Concern Subscale score greater than or equal to 3
  • Weight restored to body mass index (BMI) greater than or equal to 17.5
  • No current evidence of orthostatic hypotension or no additional fall risk as determined by provider
  • Clinical status transitioned from acute to residential
  • No new psychiatric medications in the week prior to randomization
  • Female sex assigned at birth
  • Ages 13 to 50 years
  • Independently ambulatory
  • Ability to lie flat comfortably
  • Proficient in English
  • Willingness and ability to participate in study procedures
  • Provision of informed consent (parent consent and minor assent if under 18)
Not Eligible

You will not qualify if you...

  • Active suicidal thoughts with plan and intent
  • Active cutting or skin lacerating behaviors
  • Pregnancy confirmed by urine screening
  • Acute intoxication detected by drug screen or breathalyzer
  • Orthostatic hypotension causing fall risk as determined by provider
  • Seizure within the previous 12 months
  • Bipolar disorder, schizophrenia, or other psychosis spectrum disorder
  • Systolic blood pressure above 160 mmHg
  • Diastolic blood pressure above 100 mmHg
  • Resting heart rate below 50 beats per minute

AI-Screening

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Trial Site Locations

Total: 1 location

1

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

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Research Team

E

Emily M Choquette, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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