Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
NCT ID: NCT06332963
Last Updated: 2025-09-26
Study Results
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Basic Information
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RECRUITING
NA
102 participants
INTERVENTIONAL
2024-04-19
2028-12-31
Brief Summary
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Detailed Description
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Body image, defined as the multifaceted experience of one's physical appearance, is comprised of cognitive, affective, and perceptual components. BID is a key diagnostic feature of AN that is associated with poor outcomes, including relapse following hospital discharge. It is slow to improve in women with AN, and has been consistently identified as a factor contributing to the persistence of AN symptoms and relapse following treatment.
Perceptual BID is a complex and poorly understood facet proposed to involve the integration of body-related visual signals with representations of interoceptive signals. Studies indicate women with AN overestimate their body size. Standard of care treatments for AN, such as Cognitive Behavioral Therapy, focus on modifying the cognitive/affective components of BID but rarely address the perceptual component, making it an under-investigated therapeutic target.
Diminished sensitivity to interoceptive body signals in AN may lead to an overreliance on exteroceptive (i.e., visual) body-related signals, which in turn, is likely to facilitate self-objectification (seeing one's body as an object). The outcome of this process is an inaccurate representation of physical body characteristics (i.e., perceiving one's body as larger than its true size) despite continuing to focus on it excessively. To explore whether the modulation of interoceptive signaling could improve perceptual BID in AN, we recently utilized a non-pharmacologic intervention called floatation-REST (Reduced Environmental Stimulation Therapy). During floatation-REST, input from visual, auditory, olfactory, gustatory, thermal, tactile, vestibular and proprioceptive channels are minimized, and interoceptive input is enhanced. Across two clinical trials in AN we have found that floatation-REST acutely reduces perceptual BID, indexed by the body dissatisfaction score on the Photographic Figure Rating Scale (PFRS), after one session and reliably after multiple sessions.
Acceptance and commitment therapy (ACT) for eating disorders and body image has been examined previously and evidence supports the reduction of cognitive/affective BID symptoms. The proposed study will combine floatation-REST with interoceptively focused acceptance- and mindfulness-based components (interoceptively focused therapy \[IFT\]). The primary purpose of the proposed study is to examine the acute synergistic effects of IFT and float on BID. Further, the proposed study will be the first to systematically examine associations between BID and interoception using multiple levels of analysis (i.e., self-report and behavioral assays and neuroimaging) and combine them with perturbations of interoceptive and cognitive processing to examine the impact of interoception on perceptual BID. All participants will receive a one-hour introduction session prior to being randomized on a 1:1 basis to receive three 45-minute floatation-REST sessions (to attenuate exteroceptive input and enhance interoceptive input) paired with IFT or three 45-minute self-guided exteroceptive practice sessions (active comparator to enhance cognitive/affective BID, EFT group). During the IFT/EFT sessions the skills presented have been matched as closely as possible with the exception of the focus. For example, both groups engage in contact with the present moment exercises. In the IFT group, the focus is internal body sensations; whereas in the EFT group, the focus in the experience outside the individual (e.g., their environment sights, sounds, etc). While ACT is typically conducted in longer intervals (10+ weeks of 1 hour sessions), there is growing evidence to support the potential of briefer ACT interventions.
Both groups will complete behavioral and self-report assays of interoception, perceptual and cognitive/affective BID, and state/trait illness measures pre- and post-experimental session; pre and post intervention measures including self-report, behavioral, and neurobiological assays (specifically functional magnetic resonance imaging); and longitudinal follow-ups. The ability to reliably improve BID marks a step forward in the search for more effective BID treatments for AN. Given that it is expected that acceptance and mindfulness-based components will impact affective components of body image, it is expected that there will be an additive effect on the primary outcome (perceptual BID).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
50 Years
FEMALE
No
Sponsors
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Laureate Institute for Brain Research, Inc.
OTHER
Responsible Party
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Principal Investigators
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Emily M Choquette, PhD
Role: PRINCIPAL_INVESTIGATOR
Laureate Institute for Brain Research
Locations
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Laureate Institute for Brain Research
Tulsa, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-007
Identifier Type: -
Identifier Source: org_study_id
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