Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Floatation-REST, IFT, EFT.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa, Body Image Disturbance, Interoception. Basic parameters: 13 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- 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 - 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 reviewin - 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 an
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Laureate Institute for Brain Research — Tulsa
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. PMID 33655603
- Harris EC, Barraclough B. Excess mortality of mental disorder. Br J Psychiatry. 1998 Jul;173:11-53. doi: 10.1192/bjp.173.1.11. PMID 9850203
- Hoang 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. PMID 24599787
- Khalsa 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. PMID 28630708
- Cash TF. Body image: past, present, and future. Body Image. 2004 Jan;1(1):1-5. doi: 10.1016/S1740-1445(03)00011-1. PMID 18089136
- Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available. PMID 24413388
- Keel 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. PMID 16330589
- Berends 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. PMID 30113325
Identifiers
NCT: NCT06332963 · 2023-007