NCT06332963 Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
| NCT ID | NCT06332963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laureate Institute for Brain Research, Inc. |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-04-19 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2024-04-19 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Primary diagnosis of anorexia nervosa 2. Photographic Figure Rating Scale (PFRS) body dissatisfaction score greater than or equal to 1 3. Eating Disorder Examination Questionnaire (EDE-Q6) Shape Concern Subscale score greater than or equal to 3 4. Weight restored to body mass index (BMI) greater than or equal to 17.5 5. No current evidence of orthostatic hypotension or if there is no evidence of additional fall risk as determined by their provider 6. Clinical status transition from acute to residential status 7. No new psychiatric medications in the week prior to randomization 8. Female sex assigned at birth 9. Ages 13 to 50 years 10. Independently ambulatory 11. Ability to lay flat comfortably 12. English proficiency 13. Willingness and ability to participate in study procedures 14. Provision of informed consent (parent consent and minor assent if less than 18 years of age). Exclusion Criteria: 1. Active suicidal ideation with plan and intent 2. Active cutting or skin lacerating behaviors 3. Pregnancy as defined by urine screening 4. Acute intoxication as indicated by urine drug screen or breathalyzer 5. 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. 6. Seizure reported within the previous 12 months 7. Co-morbid diagnoses of Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) bipolar disorder, schizophrenia, or other psychosis spectrum disorder 8. Systolic blood pressure \> 160 mmHg 9. Diastolic blood pressure \>100 mmHg 10. Resting heart rate \<50 beats per minute.
Contact & Investigator
Emily M Choquette, PhD
PRINCIPAL INVESTIGATOR
Laureate Institute for Brain Research
Frequently Asked Questions
Who can join the NCT06332963 clinical trial?
This trial is open to female participants only, aged 13 Years or older, up to 50 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06332963 currently recruiting?
Yes, NCT06332963 is actively recruiting participants. Contact the research team at echoquette@laureateinstitute.org for enrollment information.
Where is the NCT06332963 trial being conducted?
This trial is being conducted at Tulsa, United States.
Who is sponsoring the NCT06332963 clinical trial?
NCT06332963 is sponsored by Laureate Institute for Brain Research, Inc.. The principal investigator is Emily M Choquette, PhD at Laureate Institute for Brain Research. The trial plans to enroll 102 participants.