Suicidal IdeationRISENCT05285111
Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates
A study testing Reconnecting to Internal Sensations and Experiences and Healthy Habits in people with Suicidal Ideation and Eating Disorder Symptom, run by Auburn University at 1 site in United States.
Trial summary
Project RISE is a randomized control trial. The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation, Eating Disorder Symptom
- What is being tested?
- Reconnecting to Internal Sensations and Experiences and Healthy Habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Dec 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low interoceptive awareness
- History of suicidal ideation or attempt
- 18 or older
Who cannot join
- Below the age of 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Auburn University
Auburn, Alabama, 36849
April R Smith, PhD, 3348447011, ars0152@auburn.edu
About this study
Project RISE is a randomized control trial. The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. The comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating. Variables of interest include self-report measures of interoception, eating pathology, suicidality, physiological measures of interoception (electrocardiograph; ECG; pain tolerance measured via algometer), and an implicit association test (IAT) with death and life stimuli (meant to measure implicit associations with suicidality). The population will be college students, with current or past suicidality or low interoception.
- Conditions
- Suicidal Ideation, Eating Disorder Symptom
- Being tested
- Reconnecting to Internal Sensations and Experiences, Healthy Habits
- Medical subject headings
- Suicidal Ideation
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
The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others.
Healthy HabitsBehavioural
The comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating.
| Study group | Role | What they receive |
|---|---|---|
| Interoceptive Awareness | Experimental | The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. Receives: Behavioral: Reconnecting to Internal Sensations and Experiences |
| Healthy Habits | Active comparator | The comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating. Receives: Behavioral: Healthy Habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Assessment of Interoceptive Awareness
Assessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.
Measured: within one week of Post-test
Treatment acceptability
Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.
Measured: within one week of Post-test
Secondary outcomes (4)
Depression Screening Inventory-Suicidality Subscale
Measure of suicidal ideation, greater scores indicate more severe ideation. Scores range from 0-12. Higher scores indicate more suicidality, or a worse outcome.
Measured: within one week of Post-test
Eating Disorder Examination Questionnaire
Measure of disordered eating. Global score ranges from 0-6; greater scores indicate more severe eating disorder symptoms
Measured: within one week of Post-test
Heartbeat perception task
Measured via ECG. Perceived versus actual heartbeats are recorded across 3 trials. Scores range from 0-1; higher scores indicate greater cardiac interoceptive accuracy.
Measured: within one week of Post-test
Brief Symptom Inventory
Short measure assessing anxiety and depression symptoms. Scores range from 0-72; greater scores indicate more pathology
Measured: within one week of Post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Sep 2021
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 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
- NCT05285111
- Sponsor's protocol ID
- 22-001
- Acronym
- RISE
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates
- ClinicalTrials.gov ID
- NCT05285111
- Acronym / sponsor ID
- RISE / 22-001
- Conditions
- Suicidal Ideation, Eating Disorder Symptom
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Mar 2022 (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.
Project RISE is a randomized control trial. The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. The comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating. Variables of interest include self-report measures of interoception, eating pathology, suicidality, physiological measures of interoception (electrocardiograph; ECG; pain tolerance measured via algometer), and an implicit association test (IAT) with death and life stimuli (meant to measure implicit associations with suicidality). The population will be college students, with current or past suicidality or low interoception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interoceptive Awareness | Experimental | Behavioral: Reconnecting to Internal Sensations and ExperiencesThe intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. |
| Healthy Habits | Active comparator | Behavioral: Healthy HabitsThe comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Low interoceptive awareness
- History of suicidal ideation or attempt
- 18 or older
Key exclusion criteria (1 listed)
- Below the age of 18
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 ExperiencesThe intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. | Behavioural | Interoceptive Awareness |
| Healthy HabitsThe comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating. | Behavioural | Healthy Habits |
Primary outcome
Multidimensional Assessment of Interoceptive Awareness
Time frame: within one week of Post-test
Assessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.
Treatment acceptability
Time frame: within one week of Post-test
Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.
4 secondary outcomes
Depression Screening Inventory-Suicidality Subscale
Time frame: within one week of Post-test
Eating Disorder Examination Questionnaire
Time frame: within one week of Post-test
Heartbeat perception task
Time frame: within one week of Post-test
Brief Symptom Inventory
Time frame: within one week of Post-test
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 2 Oct 2025.
- 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.
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 and Healthy Habits in people with Suicidal Ideation and Eating Disorder Symptom, 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: looking for participants now, as of the sponsor's last update on 2 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Assessment of Interoceptive Awareness (time frame: within one week of Post-test). 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?
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 2 Oct 2025.