NCT04103385

Brief Summary

Background: Interoception is defined as the "sense of the physiological condition of the entire body" and is crucial for recognizing emotions and sensations (e.g., hunger, temperature, pain) and responding accordingly. The investigator's lab has conducted several independent studies and two pilot studies that support the hypothesis that disrupted interoception leads one to be disconnected from the body, and thus more able to harm the body should one desire to do so. Research suggests that interoceptive deficits may not only differentiate those who are thinking about suicide from those who engage in suicidal behavior, but it may also provide information about who is at imminent risk for suicidal behavior. The identification of novel, short-term risk factors, like interoceptive deficits, allows for the development of new treatment applications for suicide, which is important for several reasons: 1) suicide rates have increased in recent years, especially among military populations, and 2) existing treatment approaches are often ineffective, lengthy, expensive, or impractical for large-scale dissemination. This project evaluates a novel, brief intervention for interoceptive deficits and suicidal behavior with the potential to be acceptable and feasible for a military population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

September 19, 2019

Last Update Submit

April 15, 2022

Conditions

Keywords

interoceptionsuicidal ideationsuicidemilitaryinterventionclinical trial

Outcome Measures

Primary Outcomes (1)

  • Multidimensional Assessment of Interoceptive Awareness

    This 35-item scale has 8 subscales that measure the ability to recognize and accurately identify emotions and physiological sensations.

    Within one week of completing the intervention. Also administered at one and three month follow-up.

Secondary Outcomes (1)

  • Suicidal ideation

    Within one week of completing the intervention. Also administered at one and three month follow-up.

Other Outcomes (1)

  • Body Functionality

    Within one week of completing the intervention. Also administered at one and three month follow-up.

Study Arms (2)

Reconnecting to Internal Sensations and Experiences

EXPERIMENTAL

Aims to improve "interoception" or connection to the body's emotions \& internal sensation and reduce suicidal ideation.

Behavioral: RISE (Reconnecting to Internal Sensations and Experiences)

Restoring Individual Strength and Energy

ACTIVE COMPARATOR

Aims to reduce life stressors and improve physical health

Behavioral: RISE (Reconnecting to Individual Strength and Energy)

Interventions

The overarching goal of RISE is to increase interoception by reconnecting people with their internal sensations

Reconnecting to Internal Sensations and Experiences

Aims to reduce life stressors and improve physical health

Restoring Individual Strength and Energy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being seen for behavioral health services at Wright-Patterson Medical Center (WPMC) or Madigan Army Medical Center (MAMC) for participants recruited at those sites only; other participants were recruited through online advertisement
  • Active Duty Service Members (MAMC \& WPMC) and Veterans (online arm)
  • Between the ages of 18-65
  • English language fluency

You may not qualify if:

  • Active psychosis or mania,
  • Serious suicidal intent requiring hospitalization or immediate treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wright Patterson Medical Center

Dayton, Ohio, 45433, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (6)

  • Craig AD. How do you feel? Interoception: the sense of the physiological condition of the body. Nat Rev Neurosci. 2002 Aug;3(8):655-66. doi: 10.1038/nrn894.

    PMID: 12154366BACKGROUND
  • Forrest LN, Smith AR, White RD, Joiner TE. (Dis)connected: An examination of interoception in individuals with suicidality. J Abnorm Psychol. 2015 Aug;124(3):754-63. doi: 10.1037/abn0000074.

    PMID: 26147323BACKGROUND
  • Smith A, Forrest L, Velkoff E. Out of touch: Interoceptive deficits are elevated in suicide attempters with eating disorders. Eat Disord. 2018 Jan-Feb;26(1):52-65. doi: 10.1080/10640266.2018.1418243.

    PMID: 29384458BACKGROUND
  • Guerra VS, Calhoun PS; Mid-Atlantic Mental Illness Research, Education and Clinical Center Workgroup. Examining the relation between posttraumatic stress disorder and suicidal ideation in an OEF/OIF veteran sample. J Anxiety Disord. 2011 Jan;25(1):12-8. doi: 10.1016/j.janxdis.2010.06.025. Epub 2010 Jul 7.

    PMID: 20709493BACKGROUND
  • Nademin E, Jobes DA, Pflanz SE, Jacoby AM, Ghahramanlou-Holloway M, Campise R, Joiner T, Wagner BM, Johnson L. An investigation of interpersonal-psychological variables in air force suicides: a controlled-comparison study. Arch Suicide Res. 2008;12(4):309-26. doi: 10.1080/13811110802324847.

    PMID: 18828034BACKGROUND
  • Shelef L, Levi-Belz Y, Fruchter E. Dissociation and acquired capability as facilitators of suicide ideation among soldiers. Crisis. 2014;35(6):388-97. doi: 10.1027/0227-5910/a000278.

    PMID: 25231854BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
We will attempt to mask care provider. The Investigators will be completely blind to condition assignment. Outcomes will be assessed via computer and thus will also be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 25, 2019

Study Start

June 1, 2020

Primary Completion

November 22, 2021

Study Completion

November 22, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations