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

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.

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.

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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