Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military (RISE)
Primary Purpose
Suicidal Ideation, Interoception
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RISE (Reconnecting to Internal Sensations and Experiences)
RISE (Reconnecting to Individual Strength and Energy)
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation focused on measuring interoception, suicidal ideation, suicide, military, intervention, clinical trial
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Active psychosis or mania,
- Serious suicidal intent requiring hospitalization or immediate treatment.
Sites / Locations
- Wright Patterson Medical Center
- Madigan Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reconnecting to Internal Sensations and Experiences
Restoring Individual Strength and Energy
Arm Description
Aims to improve "interoception" or connection to the body's emotions & internal sensation and reduce suicidal ideation.
Aims to reduce life stressors and improve physical health
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Suicidal ideation
Depression Symptom Index-Suicidality Subscale; Beck Scale for Suicide Ideation
Full Information
NCT ID
NCT04103385
First Posted
September 19, 2019
Last Updated
April 15, 2022
Sponsor
Miami University
Collaborators
Auburn University
1. Study Identification
Unique Protocol Identification Number
NCT04103385
Brief Title
Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military
Acronym
RISE
Official Title
Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 22, 2021 (Actual)
Study Completion Date
November 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miami University
Collaborators
Auburn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
Specific Aims and Hypotheses:
Aim 1: Determine whether the interoception training procedure (Reconnecting to Internal Sensations and Experiences [RISE]) decreases interoceptive deficits, suicidal ideation compared to a control condition. H1: Participants receiving the interoceptive training will demonstrate decreased interoceptive deficits relative to controls and relative to their pre-training levels.
H2: Participants receiving the interoceptive training will demonstrate decreased suicidal ideation relative to controls and relative to their pre-training levels.
H3: Group differences between the interoceptive training and control conditions will be maintained at one- and three-month follow-ups.
Aim 2: Establish the feasibility and acceptability of the RISE intervention in a military sample.
H4: Participants and clinic personnel will find the intervention to be feasible and acceptable.
Study Design: Potential participants will be recruited from military bases' IOPs. Eligible participants will be invited to complete the baseline assessment and will be assigned to one of two conditions: 1) RISE, or 2) control (reading health related material). Participants in the RISE condition will complete four 45-minute online sessions of training that focus on multiple aspects of interoception including: body awareness, body sensations and movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others. Outcome assessments will be administered at post-treatment and at one- and three-month-follow-ups.
Due to the COVID-19 pandemic, which temporarily paused data collection at two of the study sites (Wright Patterson Medical Center & Madigan Army Medical Center), a fully online arm of the study was added in June 2020. Data collection was later able to be resumed at all study sites. When we added this fully arm, we increased our planned recruitment goal from 132 to 200. Data collection was ultimately concluded with an enrolled N of 195.
Military Benefit: Interoceptive deficits are an important treatment target for military personnel for several reasons. First, experiences particular to military populations (e.g., stress, trauma) are believed to lead to interoceptive deficits. Second, the broad construct of interoceptive deficits and the individual components of interoceptive deficits are related to suicidal ideation and behavior among Service members. Third, our research finds that interoceptive deficits are easily modifiable, and that increasing interoception reduces risk factors for suicide. Fourth, the entire intervention can be delivered electronically and is brief, which allows it to circumvent barriers to treatment associated with traditional face-to-face therapy. Fifth, because of its portability, the intervention can be provided to deployed Service members and it can be delivered as a standalone intervention or as an add-on to existing treatments. In sum, our proposed intervention has implications not only for the reduction of suicidal behavior, but also for improvements in military performance and future functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Interoception
Keywords
interoception, suicidal ideation, suicide, military, intervention, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reconnecting to Internal Sensations and Experiences
Arm Type
Experimental
Arm Description
Aims to improve "interoception" or connection to the body's emotions & internal sensation and reduce suicidal ideation.
Arm Title
Restoring Individual Strength and Energy
Arm Type
Active Comparator
Arm Description
Aims to reduce life stressors and improve physical health
Intervention Type
Behavioral
Intervention Name(s)
RISE (Reconnecting to Internal Sensations and Experiences)
Intervention Description
The overarching goal of RISE is to increase interoception by reconnecting people with their internal sensations
Intervention Type
Behavioral
Intervention Name(s)
RISE (Reconnecting to Individual Strength and Energy)
Intervention Description
Aims to reduce life stressors and improve physical health
Primary Outcome Measure Information:
Title
Multidimensional Assessment of Interoceptive Awareness
Description
This 35-item scale has 8 subscales that measure the ability to recognize and accurately identify emotions and physiological sensations.
Time Frame
Within one week of completing the intervention. Also administered at one and three month follow-up.
Secondary Outcome Measure Information:
Title
Suicidal ideation
Description
Depression Symptom Index-Suicidality Subscale; Beck Scale for Suicide Ideation
Time Frame
Within one week of completing the intervention. Also administered at one and three month follow-up.
Other Pre-specified Outcome Measures:
Title
Body Functionality
Description
Functionality Appreciation Scale
Time Frame
Within one week of completing the intervention. Also administered at one and three month follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Active psychosis or mania,
Serious suicidal intent requiring hospitalization or immediate treatment.
Facility Information:
Facility Name
Wright Patterson Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45433
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared with the Military Suicide Research Consortium and uploaded on a quarterly basis.
Citations:
PubMed Identifier
12154366
Citation
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.
Results Reference
background
PubMed Identifier
26147323
Citation
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.
Results Reference
background
PubMed Identifier
29384458
Citation
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.
Results Reference
background
PubMed Identifier
20709493
Citation
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.
Results Reference
background
PubMed Identifier
18828034
Citation
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.
Results Reference
background
PubMed Identifier
25231854
Citation
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.
Results Reference
background
Learn more about this trial
Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military
We'll reach out to this number within 24 hrs