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Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05285111
Acronym
RISE
Enrollment
200
Registered
2022-03-17
Start date
2021-09-01
Completion date
2026-12-31
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorder Symptom, Suicidal Ideation

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.

Interventions

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.

BEHAVIORALHealthy 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.

Sponsors

Auburn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\*Below the age of 18

Design outcomes

Primary

MeasureTime frameDescription
Multidimensional Assessment of Interoceptive Awarenesswithin one week of Post-testAssessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.
Treatment acceptabilitywithin one week of Post-testFeasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.

Secondary

MeasureTime frameDescription
Depression Screening Inventory-Suicidality Subscalewithin one week of Post-testMeasure 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 Questionnairewithin one week of Post-testMeasure of disordered eating. Global score ranges from 0-6; greater scores indicate more severe eating disorder symptoms
Heartbeat perception taskwithin one week of Post-testMeasured 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 Inventorywithin one week of Post-testShort measure assessing anxiety and depression symptoms. Scores range from 0-72; greater scores indicate more pathology

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026