Recruiting

Observational Study

Sponsor:

Laureate Institute for Brain Research, Inc.

Code:

NCT06332963

Conditions

Anorexia Nervosa

Body Image Disturbance

Interoception

Eligibility Criteria

Sex: Female

Age: 13 - 50

Healthy Volunteers: Not accepted

Interventions

Floatation-REST

IFT

EFT

Study Details

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.

Conditions

Anorexia Nervosa

Body Image Disturbance

Interoception

Study ID

NCT06332963

Start date

Apr 19, 2024

Status verified date

Sep, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 13 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interoceptively Focused Treatment (IFT)

The IFT intervention will guide participants through a tailored application of present-moment focus toward experiencing awareness and acceptance of bodily signals and defusing thoughts related to those signals. For example, participants will engage in several exercises to increase awareness of body sensations, thoughts, and emotions. IFT consists of one introduction session with a clinician (\~60 minutes) the introduction session was designed as a brief introduction to acceptance- and mindfulness-based concepts with guided practice exercises and closing time for participants to briefly process challenges to execution of exercises and the experience during the session. This is followed by three IFT sessions which combine acceptance- and mindfulness-based skills practice with floatation-REST (Reduced Environmental Stimulation Therapy via floatation).

active comparator: Exteroceptively Focused Treatment (EFT)

In the EFT condition, exercises are tailored toward experience of the present moment via external environment mindfulness (i.e., attending to experience) and defusion of thoughts. EFT consists of one introduction session with a clinician (\~60 minutes) the introduction session, similar in format to IFT, introduces acceptance- and mindfulness-based concepts. This is followed by three EFT sessions during which participants engage in brief guided skills training followed by video guided skills practice. The EFT condition is designed to increase awareness of the present moment and experience of the environment and view thoughts or emotions that may impact engagement with the current moment in a nonjudgmental way.

Interventions

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.

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.

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.

Primary outcome measure

  • Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) [ Time Frame: Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion ]
  • Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) [ Time Frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention ]

Central Contacts and Locations

Central contacts

Emily M Choquette, PhD

918-703-2343echoquette@laureateinstitute.org

Locations

Laureate Institute for Brain Research

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Emily M Choquette, PhD

918-703-2343echoquette@laureateinstitute.org

More Information

Sponsor

Laureate Institute for Brain Research, Inc.

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laureate Institute for Brain Research, Inc. on 2025-09-26.