Eating Disorder SymptomsNCT05837312
Testing the Effects of RISE on Eating Pathology
A study testing Reconnecting to Internal Sensations and Experiences in people with Eating Disorder Symptoms, run by Auburn University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Eating Disorder Symptoms
- What is being tested?
- Reconnecting to Internal Sensations and Experiences
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of an eating disorder
- Be a patient at the Louisville Center for Eating Disorders
- Above age 10
Who cannot join
- Under age 10
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisville Center For Eating Disorders
Louisville, Kentucky, 40243
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Disorder Symptoms
- Being tested
- Reconnecting to Internal Sensations and Experiences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconnecting to Internal Sensations and ExperiencesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reconnecting to Internal Sensations and Experiences |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one week of completing the intervention
Eating Disorder Inventory - Interoceptive Deficits Subscale
10 item subscale assessing interoceptive deficits, including gastrointestinal interoception
Measured: Within one week of completing the intervention
Secondary outcomes (1)
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.
Measured: Within one week of completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Feb 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Smith, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837312
- Sponsor's protocol ID
- 00001104
- Status last verified
- Oct 2025
- First submitted
- 22 Mar 2023
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34452669Smith 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.
PubMed 35204000Mehling 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.
PubMed 30513087Mond 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.
PubMed 16301014
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of Reconnecting to Internal Sensations and Experiences to Reduce Eating Pathology
- ClinicalTrials.gov ID
- NCT05837312
- Acronym / sponsor ID
- 00001104
- Conditions
- Eating Disorder Symptoms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reconnecting to Internal Sensations and Experiences | Experimental | Behavioral: Reconnecting to Internal Sensations and ExperiencesThe 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. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of an eating disorder
- Be a patient at the Louisville Center for Eating Disorders
- Above age 10
Key exclusion criteria (1 listed)
- Under age 10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reconnecting to Internal Sensations and ExperiencesReconnecting 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. | Behavioural | Reconnecting to Internal Sensations and Experiences |
Primary outcome
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.
Eating Disorder Inventory - Interoceptive Deficits Subscale
Time frame: Within one week of completing the intervention
10 item subscale assessing interoceptive deficits, including gastrointestinal interoception
1 secondary outcome
Eating Disorder Examination Questionnaire
Time frame: Within one week of completing the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Background: PubMed 34452669Smith 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.
- Background: PubMed 35204000Smith 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.
- Background: PubMed 30513087Mehling 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.
- Background: PubMed 16301014Mond 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconnecting to Internal Sensations and Experiences in people with Eating Disorder Symptoms, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Assessment of Interoceptive Awareness, Version 2 (time frame: Within one week of completing the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05837312, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.