Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

NCT06332963 | Recruiting DMC

• 1 other identifier: 2023-007
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS)

  Average change in acute body image dissatisfaction from pre- to post-experimental sessions across all three sessions (range 0 - 9, larger changes indicate greater severity of BID)

  Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion

• Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS)

  Average change in BID from pre- to post-intervention (range 0 - 9, larger changes indicate greater severity of BID).

  Through completion of post-intervention follow-up, within 2 weeks of final intervention

Secondary Outcomes (20)

• Cognitive/affective body image on the Body Image State Scale (BISS)

  Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion

• Body image dissatisfaction on the Somatomap3D

  Through completion of post-intervention follow-up, within 2 weeks of final intervention

• Appearance evaluation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Evaluation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance)

  Through completion of post-intervention follow-up, within 2 weeks of final intervention

• Appearance orientation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Orientation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance)

  Through completion of post-intervention follow-up, within 2 weeks of final intervention

• Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction

  Through completion of post-intervention follow-up, within 2 weeks of final intervention

Study Arms (2)

Interoceptively Focused Treatment (IFT)

EXPERIMENTAL

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).

Behavioral: Floatation-REST; Behavioral: IFT

Exteroceptively Focused Treatment (EFT)

ACTIVE COMPARATOR

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.

Behavioral: EFT

Interventions

Floatation-REST BEHAVIORAL

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.

Interoceptively Focused Treatment (IFT)

IFT BEHAVIORAL

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.

Also known as: acceptance- and mindfulness based intervention

Interoceptively Focused Treatment (IFT)

EFT BEHAVIORAL

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.

Also known as: acceptance- and mindfulness based intervention

Exteroceptively Focused Treatment (EFT)

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

RECRUITING

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MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Emily M Choquette, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily M Choquette, PhD

CONTACT

918-703-2343; echoquette@laureateinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Equal groups parallel randomized clinical trial

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: April 19, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)