Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

Not Applicable

Recruiting

• Conditions: Suicidal Ideation; Eating Disorder Symptom
• Interventions: Behavioral: Healthy Habits; Behavioral: Reconnecting to Internal Sensations and Experiences

• Registration Number: NCT05285111
• Lead Sponsor: Auburn University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

*Below the age of 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Habits	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.
Interoceptive Awareness	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Depression Screening Inventory-Suicidality Subscale	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.
Eating Disorder Examination Questionnaire	within one week of Post-test	Measure of disordered eating. Global score ranges from 0-6; greater scores indicate more severe eating disorder symptoms
Heartbeat perception task	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.
Brief Symptom Inventory	within one week of Post-test	Short measure assessing anxiety and depression symptoms. Scores range from 0-72; greater scores indicate more pathology

Trial Locations

Locations (1)

Auburn University; 🇺🇸 Auburn, Alabama, United States