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Suicidal IdeationRISENCT04103385

Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military

A study testing RISE (Reconnecting to Internal Sensations and Experiences) and RISE (Reconnecting to Individual Strength and Energy) in people with Suicidal Ideation and Interoception, run by Miami University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Suicidal Ideation, Interoception
What is being tested?
RISE (Reconnecting to Internal Sensations and Experiences) and RISE (Reconnecting to Individual Strength and Energy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
2 sitesUnited States
Study dates
1 Jun 2020to 22 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Wright Patterson Medical Center

    Dayton, Ohio, 45433

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

Other trials in United States

About this study

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.

Read the 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.

Being tested
RISE (Reconnecting to Internal Sensations and Experiences), RISE (Reconnecting to Individual Strength and Energy)
Keywords
interoception, suicidal ideation, suicide, military, intervention, clinical trial
Medical subject headings
Suicidal Ideation, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RISE (Reconnecting to Internal Sensations and Experiences)Behavioural

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

  • RISE (Reconnecting to Individual Strength and Energy)Behavioural

    Aims to reduce life stressors and improve physical health

Study groups in NCT04103385
Study groupRoleWhat they receive
Reconnecting to Internal Sensations and ExperiencesExperimentalAims to improve "interoception" or connection to the body's emotions \& internal sensation and reduce suicidal ideation.
Receives: Behavioral: RISE (Reconnecting to Internal Sensations and Experiences)
Restoring Individual Strength and EnergyActive comparatorAims to reduce life stressors and improve physical health
Receives: Behavioral: RISE (Reconnecting to Individual Strength and Energy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Suicidal ideation

    Depression Symptom Index-Suicidality Subscale; Beck Scale for Suicide Ideation

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start1 Jun 2020
  3. Primary completion22 Nov 2021
  4. Study completion22 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04103385
Sponsor's protocol ID
G03177
Acronym
RISE
Status last verified
Apr 2022
First submitted
19 Sep 2019
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data will be shared with the Military Suicide Research Consortium and uploaded on a quarterly basis.

Publications

  • 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.

    PubMed 12154366
  • 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.

    PubMed 26147323
  • 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.

    PubMed 29384458
  • 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.

    PubMed 20709493
  • 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.

    PubMed 18828034
  • 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.

    PubMed 25231854

Questions about this trial

What is this clinical trial studying?

A study testing RISE (Reconnecting to Internal Sensations and Experiences) and RISE (Reconnecting to Individual Strength and Energy) in people with Suicidal Ideation and Interoception, run by Miami University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multidimensional Assessment of Interoceptive Awareness (time frame: Within one week of completing the intervention. Also administered at one and three month follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04103385, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.

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