Anorexia NervosaNCT06332963
Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
A study testing Floatation-REST, IFT and EFT in people with Anorexia Nervosa and Body Image Disturbance, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 50 years, women only
- Conditions the study is for
- Anorexia Nervosa, Body Image Disturbance, Interoception
- What is being tested?
- Floatation-REST, IFT and EFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
Emily M Choquette, PhD, 918-703-2343, echoquette@laureateinstitute.org
About this study
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.
Read the detailed description
Anorexia nervosa (AN) accounts for more than 10,000 deaths per year in the United States alone, marking it as a psychiatric disorder with one of the highest standardized mortality rates. Current AN treatments have only moderate efficacy and result in relapse rates as high as 50% within one year of hospitalization. A poor understanding of the pathophysiology of AN, particularly the core diagnostic feature of body image disturbance (BID), has hindered treatment development. Abnormal interoceptive processing (i.e., internal body signal) has been proposed to contribute to BID and a mechanistic delineation of the association between interoception and BID could lead to novel interventions for AN. This proposal uses a behavioral experimental therapeutics approach to determine how modulating interoceptive processing affects BID in AN.
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
- Anorexia Nervosa, Body Image Disturbance, Interoception
- Being tested
- Floatation-REST, IFT, EFT
- Keywords
- Anorexia Nervosa, Body Image Disturbance, Perceptual Body Image, Interoception, Acceptance Based Intervention, Mindfulness Based Intervention, Randomized Clinical Trial
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floatation-RESTBehavioural
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.
IFTBehavioural
Also called acceptance- and mindfulness based intervention
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.
EFTBehavioural
Also called acceptance- and mindfulness based intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: EFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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)
Average of the change in state cognitive affective body image state pre- to post-experimental sessions across all three sessions. Items 2,4,6 are reverse coded (range 1 to 9, higher scores indicate greater satisfaction with body image)
Measured: Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion
Body image dissatisfaction on the Somatomap3D
Average of the change in anxiety rating from pre- to post-intervention sessions (measured in difference size estimation from Somatomap3D current to ideal in cm, larger discrepancy indicates greater body dissatisfaction)
Measured: 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)
Average of the change in appearance evaluation rating from pre- to post-intervention sessions
Measured: 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)
Average of the change in appearance orientation rating from pre- to post-intervention sessions (range 12 to 60, higher scores indicate more importance placed on appearance).
Measured: 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
Average of the change in body image satisfaction rating from pre- to post-intervention sessions (scores range from 9 to 45, higher scores indicate more content with body appearance)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale
Average of the change in preoccupations with gaining weight from pre- to post-intervention sessions (scores range from 4 to 20, higher scores indicate higher preoccupation)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Average change in awareness of body sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more self-reported awareness of body sensations)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Average change in extent one distracts from unpleasant sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more adaptive response to unpleasant body sensations)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Average change in extent one worries about unpleasant physical sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate less rumination about unpleasant body sensations)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Average change in ability to sustain and control attention to body sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate less rumination about unpleasant body sensations)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Average change in ability to awareness and connection between body and emotional states from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more awareness of the connection between emotion and body states)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Average change in ability to regulate distress through attention to body sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more regulation)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Average change in experiences of one's body as safe and trustworthy ability to regulate distress through attention to body sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more trust in body)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Interoceptive attention on the Interoceptive Attention Scale (IATS)
Average change in attention to interoceptive signals from pre- to post-intervention sessions (scores range from 21 to 105, higher scores indicate greater self-reported attention to internal signals)
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Cardiac interoceptive accuracy on the Heartbeat Tapping Task
Beat-to-tap consistency measure of the Heartbeat Tapping Task, higher values indicate greater consistency between actual heartbeats and perceived heartbeats.
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Cardiac interoceptive intensity on the Heartbeat Tapping Task
Intensity of cardiac signals measured via visual analog scale during the Heartbeat Tapping Task, higher values indicate greater intensity of perceived heartbeats.
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Interoceptive intensity during experimental conditions
Intensity of cardiac, respiratory, and gastric signals measured via visual analog scale pre-to -post experimental conditions, higher values indicate greater intensity
Measured: Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion
Perceived respiratory interoceptive intensity on the Breath Hold Task
Intensity of panic, suffocation, and anxiety during breath hold task measured via visual analog scale pre-to -post experimental conditions, higher values indicate greater intensity
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Body image distortion on the Aperture Task
Absolute difference between perceived size gap to fit through the aperture and actual shoulder width to pass through
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Body image distortion on the String task
Sum of the absolute difference between perceived body part size measured via string task and actual body size
Measured: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start19 Apr 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (88)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Equal groups parallel randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily M Choquette, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332963
- Sponsor's protocol ID
- 2023-007
- Status last verified
- Sep 2025
- First submitted
- 20 Mar 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Streatfeild J, Hickson J, Austin SB, Hutcheson R, Kandel JS, Lampert JG, Myers EM, Richmond TK, Samnaliev M, Velasquez K, Weissman RS, Pezzullo L. Social and economic cost of eating disorders in the United States: Evidence to inform policy action. Int J Eat Disord. 2021 May;54(5):851-868. doi: 10.1002/eat.23486. Epub 2021 Mar 2.
PubMed 33655603Harris EC, Barraclough B. Excess mortality of mental disorder. Br J Psychiatry. 1998 Jul;173:11-53. doi: 10.1192/bjp.173.1.11.
PubMed 9850203Hoang U, Goldacre M, James A. Mortality following hospital discharge with a diagnosis of eating disorder: national record linkage study, England, 2001-2009. Int J Eat Disord. 2014 Jul;47(5):507-15. doi: 10.1002/eat.22249. Epub 2014 Mar 5.
PubMed 24599787Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord. 2017 Jun 14;5:20. doi: 10.1186/s40337-017-0145-3. eCollection 2017.
PubMed 28630708Cash TF. Body image: past, present, and future. Body Image. 2004 Jan;1(1):1-5. doi: 10.1016/S1740-1445(03)00011-1.
PubMed 18089136Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
PubMed 24413388Keel PK, Dorer DJ, Franko DL, Jackson SC, Herzog DB. Postremission predictors of relapse in women with eating disorders. Am J Psychiatry. 2005 Dec;162(12):2263-8. doi: 10.1176/appi.ajp.162.12.2263.
PubMed 16330589Berends T, Boonstra N, van Elburg A. Relapse in anorexia nervosa: a systematic review and meta-analysis. Curr Opin Psychiatry. 2018 Nov;31(6):445-455. doi: 10.1097/YCO.0000000000000453.
PubMed 30113325Carter JC, Mercer-Lynn KB, Norwood SJ, Bewell-Weiss CV, Crosby RD, Woodside DB, Olmsted MP. A prospective study of predictors of relapse in anorexia nervosa: implications for relapse prevention. Psychiatry Res. 2012 Dec 30;200(2-3):518-23. doi: 10.1016/j.psychres.2012.04.037. Epub 2012 May 31.
PubMed 22657951Chapa DAN, Hagan KE, Forbush KT, Clark KE, Tregarten JP, Argue S. Longitudinal trajectories of behavior change in a national sample of patients seeking eating-disorder treatment. Int J Eat Disord. 2020 Jun;53(6):917-925. doi: 10.1002/eat.23272. Epub 2020 Apr 10.
PubMed 32275088Carter JC, Blackmore E, Sutandar-Pinnock K, Woodside DB. Relapse in anorexia nervosa: a survival analysis. Psychol Med. 2004 May;34(4):671-9. doi: 10.1017/S0033291703001168.
PubMed 15099421Glashouwer KA, van der Veer RML, Adipatria F, de Jong PJ, Vocks S. The role of body image disturbance in the onset, maintenance, and relapse of anorexia nervosa: A systematic review. Clin Psychol Rev. 2019 Dec;74:101771. doi: 10.1016/j.cpr.2019.101771. Epub 2019 Oct 31.
PubMed 31751876Stanghellini G, Ballerini M, Mancini M. The Optical-Coenaesthetic Disproportion Hypothesis of Feeding and Eating Disorders in the Light of Neuroscience. Front Psychiatry. 2019 Sep 12;10:630. doi: 10.3389/fpsyt.2019.00630. eCollection 2019.
PubMed 31607958Riva G, Gaudio S. Allocentric lock in anorexia nervosa: new evidences from neuroimaging studies. Med Hypotheses. 2012 Jul;79(1):113-7. doi: 10.1016/j.mehy.2012.03.036. Epub 2012 Apr 29.
PubMed 22546757Gadsby S. Distorted body representations in anorexia nervosa. Conscious Cogn. 2017 May;51:17-33. doi: 10.1016/j.concog.2017.02.015. Epub 2017 Mar 8.
PubMed 28284109
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06332963
- Acronym / sponsor ID
- 2023-007
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anorexia nervosa (AN) accounts for more than 10,000 deaths per year in the United States alone, marking it as a psychiatric disorder with one of the highest standardized mortality rates. Current AN treatments have only moderate efficacy and result in relapse rates as high as 50% within one year of hospitalization. A poor understanding of the pathophysiology of AN, particularly the core diagnostic feature of body image disturbance (BID), has hindered treatment development. Abnormal interoceptive processing (i.e., internal body signal) has been proposed to contribute to BID and a mechanistic delineation of the association between interoception and BID could lead to novel interventions for AN. This proposal uses a behavioral experimental therapeutics approach to determine how modulating interoceptive processing affects BID in AN.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Equal groups parallel randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Interoceptively Focused Treatment (IFT) | Experimental | Behavioral: Floatation-REST, Behavioral: IFTThe 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). |
| Exteroceptively Focused Treatment (EFT) | Active comparator | Behavioral: EFTIn 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. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floatation-RESTParticipants 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. | Behavioural | Interoceptively Focused Treatment (IFT) |
| IFTAlso: acceptance- and mindfulness based interventionTwo 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. | Behavioural | Interoceptively Focused Treatment (IFT) |
| EFTAlso: acceptance- and mindfulness based interventionTwo 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. | Behavioural | Exteroceptively Focused Treatment (EFT) |
Primary outcome
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
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)
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
Average change in BID from pre- to post-intervention (range 0 - 9, larger changes indicate greater severity of BID).
20 secondary outcomes
Cognitive/affective body image on the Body Image State Scale (BISS)
Time frame: Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion
Body image dissatisfaction on the Somatomap3D
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Interoceptive attention on the Interoceptive Attention Scale (IATS)
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Cardiac interoceptive accuracy on the Heartbeat Tapping Task
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Cardiac interoceptive intensity on the Heartbeat Tapping Task
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Interoceptive intensity during experimental conditions
Time frame: Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion
Perceived respiratory interoceptive intensity on the Breath Hold Task
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Body image distortion on the Aperture Task
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Body image distortion on the String task
Time frame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 33655603Streatfeild J, Hickson J, Austin SB, Hutcheson R, Kandel JS, Lampert JG, Myers EM, Richmond TK, Samnaliev M, Velasquez K, Weissman RS, Pezzullo L. Social and economic cost of eating disorders in the United States: Evidence to inform policy action. Int J Eat Disord. 2021 May;54(5):851-868. doi: 10.1002/eat.23486. Epub 2021 Mar 2.
- Background: PubMed 9850203Harris EC, Barraclough B. Excess mortality of mental disorder. Br J Psychiatry. 1998 Jul;173:11-53. doi: 10.1192/bjp.173.1.11.
- Background: PubMed 24599787Hoang U, Goldacre M, James A. Mortality following hospital discharge with a diagnosis of eating disorder: national record linkage study, England, 2001-2009. Int J Eat Disord. 2014 Jul;47(5):507-15. doi: 10.1002/eat.22249. Epub 2014 Mar 5.
- Background: PubMed 28630708Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord. 2017 Jun 14;5:20. doi: 10.1186/s40337-017-0145-3. eCollection 2017.
- Background: PubMed 18089136Cash TF. Body image: past, present, and future. Body Image. 2004 Jan;1(1):1-5. doi: 10.1016/S1740-1445(03)00011-1.
- Background: PubMed 24413388Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
- Background: PubMed 16330589Keel PK, Dorer DJ, Franko DL, Jackson SC, Herzog DB. Postremission predictors of relapse in women with eating disorders. Am J Psychiatry. 2005 Dec;162(12):2263-8. doi: 10.1176/appi.ajp.162.12.2263.
- Background: PubMed 30113325Berends T, Boonstra N, van Elburg A. Relapse in anorexia nervosa: a systematic review and meta-analysis. Curr Opin Psychiatry. 2018 Nov;31(6):445-455. doi: 10.1097/YCO.0000000000000453.
- Background: PubMed 22657951Carter JC, Mercer-Lynn KB, Norwood SJ, Bewell-Weiss CV, Crosby RD, Woodside DB, Olmsted MP. A prospective study of predictors of relapse in anorexia nervosa: implications for relapse prevention. Psychiatry Res. 2012 Dec 30;200(2-3):518-23. doi: 10.1016/j.psychres.2012.04.037. Epub 2012 May 31.
- Background: PubMed 32275088Chapa DAN, Hagan KE, Forbush KT, Clark KE, Tregarten JP, Argue S. Longitudinal trajectories of behavior change in a national sample of patients seeking eating-disorder treatment. Int J Eat Disord. 2020 Jun;53(6):917-925. doi: 10.1002/eat.23272. Epub 2020 Apr 10.
- Background: PubMed 15099421Carter JC, Blackmore E, Sutandar-Pinnock K, Woodside DB. Relapse in anorexia nervosa: a survival analysis. Psychol Med. 2004 May;34(4):671-9. doi: 10.1017/S0033291703001168.
- Background: PubMed 31751876Glashouwer KA, van der Veer RML, Adipatria F, de Jong PJ, Vocks S. The role of body image disturbance in the onset, maintenance, and relapse of anorexia nervosa: A systematic review. Clin Psychol Rev. 2019 Dec;74:101771. doi: 10.1016/j.cpr.2019.101771. Epub 2019 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily M Choquette, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floatation-REST, IFT and EFT in people with Anorexia Nervosa and Body Image Disturbance, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily M Choquette, PhD (918-703-2343, echoquette@laureateinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332963, which also lists 88 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.