Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332963
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-20
Brief Title:
Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
Sponsor:
Laureate Institute for Brain Research Inc
Organization:
Laureate Institute for Brain Research Inc
Study Overview
Official Title:
Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Anorexia nervosa AN accounts for more than 10000 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 ie 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 ones 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 cognitiveaffective 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 ie visual body-related signals which in turn is likely to facilitate self-objectification seeing ones body as an object The outcome of this process is an inaccurate representation of physical body characteristics ie perceiving ones 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 cognitiveaffective 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 ie 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 11 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 cognitiveaffective BID EFT group During the IFTEFT 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 eg 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 cognitiveaffective BID and statetrait 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
Body image defined as the multifaceted experience of ones 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 cognitiveaffective 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 ie visual body-related signals which in turn is likely to facilitate self-objectification seeing ones body as an object The outcome of this process is an inaccurate representation of physical body characteristics ie perceiving ones 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 cognitiveaffective 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 ie 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 11 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 cognitiveaffective BID EFT group During the IFTEFT 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 eg 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 cognitiveaffective BID and statetrait 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None