Pilot of Reconnecting to Internal Sensations and Experiences in Undergraduates

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAuburn University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Low interoceptive awareness

History of suicidal ideation or attempt

18 or older

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Reconnecting to Internal Sensations and Experiences

    Behavioral

    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

    Behavioral

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Interoceptive AwarenessExperimental treatment 1 intervention
Group B: Healthy HabitsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Multidimensional Assessment of Interoceptive Awareness

Assessment of Interoceptive Awareness. Total scores range from 0-175. Higher scores indicate a better outcome.

Time frame
within one week of Post-test
2

Treatment acceptability

Feasibility and Acceptability questions. Scores range from 4-28. Higher scores indicate a better outcome.

Time frame
within one week of Post-test

Secondary outcomes

1

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.

Time frame
within one week of Post-test
2

Eating Disorder Examination Questionnaire

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
3

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.

Time frame
within one week of Post-test
4

Brief Symptom Inventory

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

Other outcomes

Sponsors and contacts

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