Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

Study Overview
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Brief Summary
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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.

Official Title
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Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

Conditions
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Suicidal Ideation, Eating Disorder Symptom

Intervention / Treatment
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* Behavioral: Reconnecting to Internal Sensations and Experiences
* Behavioral: Healthy Habits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low interoceptive awareness History of suicidal ideation or attempt 18 or older Exclusion Criteria: *Below the age of 18

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interoceptive Awareness<br>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<br>* 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.<br>|
| Active Comparator: Healthy Habits<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |