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Recruiting NCT05285111

Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

No phase Interventional Suicidal Ideation Eating Disorder Symptom

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reconnecting to Internal Sensations and Experiences, Healthy Habits.
Who it may be relevant to
Registry conditions: Suicidal Ideation, Eating Disorder Symptom. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Multidimensional Assessment of Interoceptive Awareness [Time frame: within one week of Post-test]
  • Treatment acceptability [Time frame: within one week of Post-test]
Secondary outcome measures (4)
  • Depression Screening Inventory-Suicidality Subscale [Time frame: within one week of Post-test]
  • Eating Disorder Examination Questionnaire [Time frame: within one week of Post-test]
  • Heartbeat perception task [Time frame: within one week of Post-test]
  • Brief Symptom Inventory [Time frame: within one week of Post-test]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\*Below the age of 18

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Auburn University — Auburn

Identifiers

NCT: NCT05285111 · 22-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗