RECRUITING

Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

Quick Facts

Study Start:2024-04-19
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06332963

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Primary diagnosis of anorexia nervosa
  2. 2. Photographic Figure Rating Scale (PFRS) body dissatisfaction score greater than or equal to 1
  3. 3. Eating Disorder Examination Questionnaire (EDE-Q6) Shape Concern Subscale score greater than or equal to 3
  4. 4. Weight restored to body mass index (BMI) greater than or equal to 17.5
  5. 5. No current evidence of orthostatic hypotension
  6. 6. Clinical status transition from acute to residential status
  7. 7. No new psychiatric medications in the week prior to randomization
  8. 8. Female sex assigned at birth
  9. 9. Ages 15 to 40 years
  10. 10. Independently ambulatory
  11. 11. Ability to lay flat comfortably
  12. 12. English proficiency
  13. 13. Willingness and ability to participate in study procedures
  14. 14. Provision of informed consent (parent consent and minor assent if less than 18 years of age).
  1. 1. Active suicidal ideation with plan and intent
  2. 2. Active cutting or skin lacerating behaviors
  3. 3. Pregnancy as defined by urine screening
  4. 4. Acute intoxication as indicated by urine drug screen or breathalyzer
  5. 5. Orthostatic hypotension (defined as a drop of ≥ 20 mmHg in systolic blood pressure (SBP) or a drop of ≥ 10 mm Hg in diastolic blood pressure (DBP) when measured shortly after transitioning from lying down to standing)
  6. 6. Seizure reported within the previous 12 months
  7. 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. 8. Systolic blood pressure \> 160 mmHg
  9. 9. Diastolic blood pressure \>100 mmHg
  10. 10. Resting heart rate \<50 beats per minute.

Contacts and Locations

Study Contact

Emily M Choquette, PhD
CONTACT
918-703-2343
echoquette@laureateinstitute.org

Principal Investigator

Emily M Choquette, PhD
PRINCIPAL_INVESTIGATOR
Laureate Institute for Brain Research

Study Locations (Sites)

Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
United States

Collaborators and Investigators

Sponsor: Laureate Institute for Brain Research, Inc.

  • Emily M Choquette, PhD, PRINCIPAL_INVESTIGATOR, Laureate Institute for Brain Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-19
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-04-19
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Anorexia Nervosa
  • Body Image Disturbance
  • Perceptual Body Image
  • Interoception
  • Acceptance Based Intervention
  • Mindfulness Based Intervention
  • Randomized Clinical Trial

Additional Relevant MeSH Terms

  • Anorexia Nervosa
  • Body Image Disturbance
  • Interoception