- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05837312
Testing the Effects of RISE on Eating Pathology
October 15, 2025 updated by: April Smith, Auburn University
Pilot Test of Reconnecting to Internal Sensations and Experiences to Reduce Eating Pathology
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40243
- Louisville Center For Eating Disorders
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reconnecting to Internal Sensations and Experiences
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multidimensional Assessment of Interoceptive Awareness, Version 2
Time Frame: Within one week of completing the intervention
|
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
Time Frame: Within one week of completing the intervention
|
10 item subscale assessing interoceptive deficits, including gastrointestinal interoception
|
Within one week of completing the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating Disorder Examination Questionnaire
Time Frame: Within one week of completing the intervention
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Acceptability Questionnaire
Time Frame: Within one week of completing the intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
March 22, 2023
First Submitted That Met QC Criteria
April 19, 2023
First Posted (Actual)
May 1, 2023
Study Record Updates
Last Update Posted (Actual)
October 20, 2025
Last Update Submitted That Met QC Criteria
October 15, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00001104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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