RECRUITINGINTERVENTIONAL

Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form (parent consent and minor assent if less than 18 years of age). Who Should NOT Join This Trial: 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 \&amp;gt; 160 mmHg 9. Diastolic blood pressure \&amp;gt;100 mmHg ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 \&amp;gt; 160 mmHg 9. Diastolic blood pressure \&amp;gt;100 mmHg 10. Resting heart rate \&amp;lt;50 beats per minute.

Treatments Being Tested

BEHAVIORAL

Floatation-REST

Participants lay supine in one of two circular fiberglass pools that were custom-designed for research purposes. The floatation pools are 8 feet in diameter and contain 11 inches of reverse osmosis water saturated with \~1,800 pounds of Epsom salt (magnesium sulfate). This creates a dense saltwater solution with a specific gravity of \~1.26, allowing participants to effortlessly float on their back while the water hovers just above the ears. The temperature of the water and air is calibrated to approximate skin temperature (\~95.0 °F), helping to minimize the need for thermoregulation while reducing the boundary between air, body, and water. Clothing is usually not worn while floating since anything touching the body can generate somatosensory stimulation, detracting from the float experience. However, participants have the option to choose if they would prefer to float with a bathing suit or nude. During floatation-REST, visual, auditory, olfactory stimuli are minimized.

BEHAVIORAL

IFT

Two ACT principles, contact with the present moment and cognitive defusion were utilized in the development of the intervention. In the IFT condition, awareness and acceptance of bodily signals, thoughts, and emotions and being present with one's self (i.e., mindfulness focus is inward) are emphasized. All participants will engage in an introduction session. Followed by three IFT sessions. The experimental sessions are formatted the same for both conditions. Each begins with a clinician reviewing previous constructs and introducing a new skill. Then participants engage in their assigned condition intervention, followed by a debrief with a clinician. Practices in both conditions are matched as closely as possible for content. The mindful focus of IFT is internal toward thoughts, emotions, and body sensations. In the experimental sessions, participants will engage in a floatation-REST session while practicing acceptance and mindfulness-based skills presented to them.

BEHAVIORAL

EFT

Two acceptance and commitment therapy modules contact with the present moment and cognitive defusion were utilized in the development of the intervention. In the EFT condition, awareness and acceptance of thoughts and emotions and mindfulness of current experience are emphasized. The mindful focus of EFT is external, toward attending to experience as well as thoughts and emotions. During experimental sessions, participants will engage in a self-guided and computer-based practice of acceptance and mindfulness-based skills. These videos were created to ensure content was congruent with the material presented in the introduction sessions and represent skills that build from session to session.

Locations (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States