Clinical trial NCT04103385: Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military
Official title: Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Interoception
Keywords: interoception
suicidal ideation
suicide
military
intervention
clinical trial
Lead sponsor: Miami University
Sponsor class: OTHER
Collaborators: name: Auburn University
First posted: 2019-09-25
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Multidimensional Assessment of Interoceptive Awareness
timeFrame: Within one week of completing the intervention. Also administered at one and three month follow-up.
Secondary outcomes:
measure: Suicidal ideation
timeFrame: Within one week of completing the intervention. Also administered at one and three month follow-up.
Other outcomes:
measure: Body Functionality
timeFrame: Within one week of completing the intervention. Also administered at one and three month follow-up.
Locations:
city: Dayton
country: United States
facility: Wright Patterson Medical Center
state: Ohio
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References:
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.
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.
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.
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.
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.
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.