Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

Suicidal Ideation Clinical Trial

— RISE  

Official title:

Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285111
• Other study ID #: 22-001
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Low interoceptive awareness

• History of suicidal ideation or attempt

• 18 or older

Exclusion Criteria:

*Below the age of 18

Related Conditions & MeSH terms

• Eating Disorder Symptom
• Feeding and Eating Disorders
• Suicidal Ideation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Treatment acceptability	Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.	within one week of Post-test
Secondary	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
Secondary	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
Secondary	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
Secondary	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