Testing the Effects of RISE on Eating Pathology

NCT05837312 | Active Not Recruiting

• 1 other identifier: 00001104
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorder Symptoms

Outcome Measures

Primary Outcomes (2)

• 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

• Eating Disorder Inventory - Interoceptive Deficits Subscale

  10 item subscale assessing interoceptive deficits, including gastrointestinal interoception

  Within one week of completing the intervention

Secondary Outcomes (1)

• Eating Disorder Examination Questionnaire

  Within one week of completing the intervention

Other Outcomes (1)

• Treatment Acceptability Questionnaire

  Within one week of completing the intervention

Study Arms (1)

Reconnecting to Internal Sensations and Experiences

EXPERIMENTAL

The interoceptive training consists of four 25-30 minute modules (plus 15-minutes worth of optional weekly practice) that focus on multiple aspects of interoception including: body awareness, body sensations and movement, eating, health and selfcare, emotional awareness, and understanding the self in relation to others. These modules are delivered weekly.

Behavioral: Reconnecting to Internal Sensations and Experiences

Interventions

Reconnecting to Internal Sensations and Experiences BEHAVIORAL

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.

Reconnecting to Internal Sensations and Experiences

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \*Under age 10

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Louisville Center For Eating Disorders

Louisville, Kentucky, 40243, United States

Location

Related Publications (4)

• 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.

  PMID: 34452669 BACKGROUND

• 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.

  PMID: 35204000 BACKGROUND

• 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.

  PMID: 30513087 BACKGROUND

• 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.

  PMID: 16301014 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 1, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)