Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates (RISE)
Primary Purpose
Suicidal Ideation, Eating Disorder Symptom
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reconnecting to Internal Sensations and Experiences
Healthy Habits
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation
Eligibility Criteria
Inclusion Criteria:
- Low interoceptive awareness
- History of suicidal ideation or attempt
- 18 or older
Exclusion Criteria:
*Below the age of 18
Sites / Locations
- Auburn UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interoceptive Awareness
Healthy Habits
Arm Description
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.
Outcomes
Primary Outcome Measures
Multidimensional Assessment of Interoceptive Awareness
Assessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.
Treatment acceptability
Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.
Secondary Outcome Measures
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.
Eating Disorder Examination Questionnaire
Measure of disordered eating. Global score ranges from 0-6; greater scores indicate more severe eating disorder symptoms
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.
Brief Symptom Inventory
Short measure assessing anxiety and depression symptoms. Scores range from 0-72; greater scores indicate more pathology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05285111
Brief Title
Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates
Acronym
RISE
Official Title
Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Eating Disorder Symptom
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interoceptive Awareness
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Habits
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reconnecting to Internal Sensations and Experiences
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Habits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Multidimensional Assessment of Interoceptive Awareness
Description
Assessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.
Time Frame
within one week of Post-test
Title
Treatment acceptability
Description
Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.
Time Frame
within one week of Post-test
Secondary Outcome Measure Information:
Title
Depression Screening Inventory-Suicidality Subscale
Description
Measure of suicidal ideation, greater scores indicate more severe ideation. Scores range from 0-12. Higher scores indicate more suicidality, or a worse outcome.
Time Frame
within one week of Post-test
Title
Eating Disorder Examination Questionnaire
Description
Measure of disordered eating. Global score ranges from 0-6; greater scores indicate more severe eating disorder symptoms
Time Frame
within one week of Post-test
Title
Heartbeat perception task
Description
Measured via ECG. Perceived versus actual heartbeats are recorded across 3 trials. Scores range from 0-1; higher scores indicate greater cardiac interoceptive accuracy.
Time Frame
within one week of Post-test
Title
Brief Symptom Inventory
Description
Short measure assessing anxiety and depression symptoms. Scores range from 0-72; greater scores indicate more pathology
Time Frame
within one week of Post-test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Low interoceptive awareness
History of suicidal ideation or attempt
18 or older
Exclusion Criteria:
*Below the age of 18
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April R Smith, PhD
Phone
334-844-7011
Email
ars0152@auburn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates
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