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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Suicidal Ideation, Interoception
- 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 group | Role | What they receive |
|---|---|---|
| Reconnecting to Internal Sensations and Experiences | Experimental | Aims 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 Energy | Active comparator | Aims 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.
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)
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.
- First posted25 Sep 2019
- Study start1 Jun 2020
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Miami University
- Sponsor type
- University, hospital or other
- Collaborators
- Auburn University
- Responsible party
- Principal investigator, April Smith, Auburn University
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 12154366Forrest 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 26147323Smith 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 29384458Guerra 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 20709493Nademin 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 18828034Shelef 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconnecting: Improving Interoception to Reduce Suicidal Ideation in the Military
- ClinicalTrials.gov ID
- NCT04103385
- Acronym / sponsor ID
- RISE / G03177
- Conditions
- Suicidal Ideation, Interoception
- Keywords
- interoception, suicidal ideation, suicide, military, intervention, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Miami UniversityUniversity, hospital or other
- Collaborators
- Auburn University
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reconnecting to Internal Sensations and Experiences | Experimental | Behavioral: RISE (Reconnecting to Internal Sensations and Experiences)Aims to improve "interoception" or connection to the body's emotions \& internal sensation and reduce suicidal ideation. |
| Restoring Individual Strength and Energy | Active comparator | Behavioral: RISE (Reconnecting to Individual Strength and Energy)Aims to reduce life stressors and improve physical health |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Active psychosis or mania,
- Serious suicidal intent requiring hospitalization or immediate treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISE (Reconnecting to Internal Sensations and Experiences)The overarching goal of RISE is to increase interoception by reconnecting people with their internal sensations | Behavioural | Reconnecting to Internal Sensations and Experiences |
| RISE (Reconnecting to Individual Strength and Energy)Aims to reduce life stressors and improve physical health | Behavioural | Restoring Individual Strength and Energy |
Primary outcome
Multidimensional Assessment of Interoceptive Awareness
Time frame: Within one week of completing the intervention. Also administered at one and three month follow-up.
This 35-item scale has 8 subscales that measure the ability to recognize and accurately identify emotions and physiological sensations.
1 secondary outcome
Suicidal ideation
Time frame: Within one week of completing the intervention. Also administered at one and three month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Background: PubMed 12154366Craig 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.
- Background: PubMed 26147323Forrest 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.
- Background: PubMed 29384458Smith 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.
- Background: PubMed 20709493Guerra 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.
- Background: PubMed 18828034Nademin 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.
- Background: PubMed 25231854Shelef 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.
- Individual participant dataSharing planned: Undecided. Data will be shared with the Military Suicide Research Consortium and uploaded on a quarterly basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.