RISE: Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

• Sponsor: Auburn University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05285111
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation; Eating Disorder Symptom	Behavioral: Reconnecting to Internal Sensations and Experiences; Behavioral: Healthy Habits	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Treatment acceptability [within one week of Post-test]

   Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.

Secondary Outcome Measures

1. 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.

2. 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

3. 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.

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Low interoceptive awareness

• History of suicidal ideation or attempt

• 18 or older

Exclusion Criteria:

*Below the age of 18

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Auburn University	Auburn	Alabama	United States	36849

Sponsors and Collaborators

• Auburn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: April Smith, Assistant Professor, Auburn University
• ClinicalTrials.gov Identifier: NCT05285111
• Other Study ID Numbers: 22-001
• First Posted: Mar 17, 2022
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Feeding and Eating Disorders; Suicidal Ideation

Study Results

No Results Posted as of Mar 31, 2022