Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

NCT05285111 | Recruiting

• 1 other identifier: 22-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Depression Screening Inventory-Suicidality Subscale

  within one week of Post-test

• Eating Disorder Examination Questionnaire

  within one week of Post-test

• Heartbeat perception task

  within one week of Post-test

• Brief Symptom Inventory

  within one week of Post-test

Study Arms (2)

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.

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.

Behavioral: Healthy Habits

Interventions

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.

Interoceptive Awareness

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.

Healthy Habits

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \*Below the age of 18

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 17, 2022
• Study Start: September 1, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)