Testing the Effects of RISE on Eating Pathology

Eating Disorder Symptoms Clinical Trial

Official title:

Pilot Test of Reconnecting to Internal Sensations and Experiences to Reduce Eating Pathology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05837312
• Other study ID #: 00001104
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: Auburn University
• Contact: April Smith
• Phone: 3348447011
• Email: ars0152[@]auburn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Disorder Symptoms
• Feeding and Eating Disorders

Intervention

Behavioral:
• Reconnecting to Internal Sensations and Experiences
Reconnecting to Internal Sensations and Experiences (RISE) is a novel, self-guided interoceptive intervention designed to be accessible and convenient. RISE is hosted on Qualtrics and accessed on any internet-enabled device. RISE consists of four interactive 30-minute modules: (1) Progressive Muscle Relaxation and Body Functionality, (2) Understanding, Noticing and Managing Emotions, (3) Self-care and Communication, and (4) Body Sensations. The training consists of a mix of audio clips, psychoeducation, self-guided reading, and interactive writing prompts. Intervention materials are separated by multiple free-response prompts so that participants can relate the materials to their own lives, practice the introduced skills, and problem-solve difficulties implementing the skills.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Acceptability Questionnaire	The Treatment Acceptability Questionnaire (TAQ) is a 6-item self-report assessment of the acceptability of the treatment. However in the current study the item pertaining to "How knowledgeable the psychologist is" will be removed as the intervention is delivered online; thus, the TAQ will be assessed with 5 items. Items are rated on a 1-7 Likert scale, and scores can range from 1-35. Higher scores indicate more treatment acceptability.	Within one week of completing the intervention
Primary	Multidimensional Assessment of Interoceptive Awareness, Version 2	The Multidimensional Assessment of Interoceptive Awareness, Version 2 is 37-item scale that has 8 subscales that measure the ability to recognize and accurately identify emotions and physiological sensations. Each item is rated on a 0-5 Likert scale, thus total scores can range from 0-185. Higher scores indicate better interoceptive awareness.	Within one week of completing the intervention
Secondary	Eating Disorder Examination Questionnaire	The Eating Disorder Examination Questionnaire is a self-report assessment of eating disorder symptoms that assesses eating disorder behaviors (e.g., excessive exercise, binging, purging, fasting) and includes 4 subscales: weight concerns, shape concerns, restraint, and eating concerns. Items are rated on a 0 (No days) to 6 (Every day) scale. The global score is computed by summing the items and taking the mean, thus scores can range from 0-6. Higher scores indicate more eating pathology.	Within one week of completing the intervention