Clinical trial NCT05837312: Testing the Effects of RISE on Eating Pathology
Official title: Pilot Test of Reconnecting to Internal Sensations and Experiences to Reduce Eating Pathology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorder Symptoms
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interoception is the process of perceiving one's bodily sensations. Interoception is critical for survival and maintaining homeostasis, as it motivates sensation- and need-specific autonomic reflexes and adaptive behaviors (e.g., eating when hungry, terminating eating upon fullness, drinking when thirsty). Not all individuals have accurate interoceptive abilities. Individuals with eating disorders often have low perception of gastrointestinal, pain, and emotion sensations. Interoceptive dysfunction is believed to influence the development and maintenance of many forms of psychopathology. Identifying effective ways to restore accurate interoceptive processing is an important aim for clinical researchers. The goal of the present study is to continue to test the effectiveness of a training for interoceptive dysfunction that aims to reconnect individuals with eating disorders with their internal sensations, which is called, Reconnecting to Internal Sensations.

Detailed description: There are individual differences in how well people are able to recognize interoceptive sensations. Research supports a role for impaired interoception in the etiology of eating disorders (EDs), with the idea being that individuals who are out of touch with hunger and/or satiety are more vulnerable to restrictive and binge eating behaviors, respectively. Researchers have connected interoceptive impairment to self-injurious behaviors more broadly, including both direct (i.e., non-suicidal self-injury and suicide attempts) and indirect (i.e., ED behaviors) forms. The investigators have found support for the supposition that impaired interoception-or bodily disconnect-allows people to inflict pain (whether that be through ED behaviors or self-injury) upon themselves, as it is much easier to harm something one is unattached to versus something one cares for. Thus, improving interoception (e.g., helping people connect better with their bodies) may improve ED outcomes. This project seeks to test an accessible, online intervention designed to improve interoception and thereby reduce ED symptoms.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of an eating disorder
* Be a patient at the Louisville Center for Eating Disorders
* Above age 10

Exclusion Criteria:

\*Under age 10

Primary outcomes:
measure: Multidimensional Assessment of Interoceptive Awareness, Version 2
timeFrame: Within one week of completing the intervention
Secondary outcomes:
measure: Eating Disorder Examination Questionnaire
timeFrame: Within one week of completing the intervention
Other outcomes:
measure: Treatment Acceptability Questionnaire
timeFrame: Within one week of completing the intervention
Locations:
city: Louisville
country: United States
facility: Louisville Center For Eating Disorders
state: Kentucky
Study officials:
References:
citation: Smith AR, Forrest LN, Perkins NM, Kinkel-Ram S, Bernstein MJ, Witte TK. Reconnecting to Internal Sensation and Experiences: A Pilot Feasibility Study of an Online Intervention to Improve Interoception and Reduce Suicidal Ideation. Behav Ther. 2021 Sep;52(5):1145-1157. doi: 10.1016/j.beth.2021.02.001. Epub 2021 Feb 20.
citation: Smith AR, Kinkel-Ram S, Grunwald W, George TS, Raval V. A Pilot Feasibility Study of Reconnecting to Internal Sensations and Experiences (RISE), a Mindfulness-Informed Intervention to Reduce Interoceptive Dysfunction and Suicidal Ideation, among University Students in India. Brain Sci. 2022 Feb 9;12(2):237. doi: 10.3390/brainsci12020237.
citation: Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
citation: Mond JM, Hay PJ, Rodgers B, Owen C. Eating Disorder Examination Questionnaire (EDE-Q): norms for young adult women. Behav Res Ther. 2006 Jan;44(1):53-62. doi: 10.1016/j.brat.2004.12.003.