Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

Recruiting now · Not applicable

Conditions studied: Anorexia Nervosa, Body Image Disturbance, Interoception

In brief

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.

Key facts

Study ID

NCT06332963

Run by

Laureate Institute for Brain Research, Inc.

People needed

102

Starts

2024-04-19

Expected to finish

2028-12-01

Last updated by the study team

2025-09-26

Who can join

Age: 13 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 if there is no evidence of additional fall risk as determined by their provider
• Clinical status transition from acute to residential status
• No new psychiatric medications in the week prior to randomization
• Female sex assigned at birth
• Ages 13 to 50 years
• Independently ambulatory
• Ability to lay flat comfortably
• English proficiency
• Willingness and ability to participate in study procedures
• Provision of informed consent (parent consent and minor assent if less than 18 years of age).

You may not qualify if…

• Active suicidal ideation with plan and intent
• Active cutting or skin lacerating behaviors
• Pregnancy as defined by urine screening
• Acute intoxication as indicated by urine drug screen or breathalyzer
• Orthostatic hypotension as determined by medical provider, evidenced in chart (defined as a drop of ≥ 20 mmHg in systolic blood pressure (BP) or a drop of ≥ 10 mm Hg in diastolic blood pressure (BP) when measured shortly after transitioning from lying down to standing). If evidence of orthostasis is present in chart consultation with provider to determine if status creates additional fall risk. If participant is determined to be at increased fall risk (e.g., dizziness upon standing) they will be excluded.
• Seizure reported within the previous 12 months
• Co-morbid diagnoses of Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) bipolar disorder, schizophrenia, or other psychosis spectrum disorder
• Systolic blood pressure \> 160 mmHg
• Diastolic blood pressure \>100 mmHg
• Resting heart rate \<50 beats per minute.

Where it is running

• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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