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NCT Number: NCT05285111

Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

Location status: Recruiting

Location contact

April R Smith, PhD

CONTACT

[email protected]

3348447011

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Low interoceptive awareness
  • History of suicidal ideation or attempt
  • 18 or older

Exclusion criteria

*Below the age of 18

Treatment and study plan

Reconnecting to Internal Sensations and Experiences

Behavioral

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 Habits

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Depression Screening Inventory-Suicidality Subscale

    Time frame: within one week of Post-test

    Measure of suicidal ideation, greater scores indicate more severe ideation. Scores range from 0-12. Higher scores indicate more suicidality, or a worse outcome.

  2. Eating Disorder Examination Questionnaire

    Time frame: within one week of Post-test

    Measure of disordered eating. Global score ranges from 0-6; greater scores indicate more severe eating disorder symptoms

  3. Heartbeat perception task

    Time frame: within one week of Post-test

    Measured via ECG. Perceived versus actual heartbeats are recorded across 3 trials. Scores range from 0-1; higher scores indicate greater cardiac interoceptive accuracy.

  4. Brief Symptom Inventory

    Time frame: within one week of Post-test

    Short measure assessing anxiety and depression symptoms. Scores range from 0-72; greater scores indicate more pathology

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Acronym: RISE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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