Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates (RISE)

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 Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Eating Disorder Symptom
• Intervention / Treatment: Behavioral: Reconnecting to Internal Sensations and Experiences; Behavioral: Healthy Habits

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Recruiting
      • Auburn University
      • Contact: April R Smith, PhD; Phone Number: 3348447011; Email: ars0152@auburn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

*Below the age of 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interoceptive Awareness; 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.	Behavioral: Reconnecting to Internal Sensations and Experiences; 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.
Active Comparator: Healthy Habits; 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.	Behavioral: Healthy Habits; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional Assessment of Interoceptive Awareness	Assessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.	within one week of Post-test
Treatment acceptability	Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.	within one week of Post-test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	within one week of Post-test

Collaborators and Investigators

• Sponsor: Auburn University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicidal Ideation
• Other Study ID Numbers: 22-001

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