Interoception-Focused Therapy for Suicidal Thoughts

(RISE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Auburn University

Disqualifiers: Under 18

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to help college students with suicidal thoughts or poor body signal awareness understand their body signals and emotions better. The goal is to improve their mental health and reduce harmful behaviors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Healthy Habits, Reconnecting to Internal Sensations and Experiences, RISE, Reconnecting to Internal Sensations and Experiences for suicidal thoughts?

Research shows that the RISE treatment, which focuses on improving interoception (awareness of internal body sensations), has been linked to reductions in suicidal thoughts and improvements in body awareness. Studies have found that this approach is promising in reducing suicide-related outcomes and is well-received by participants. ^{1 2 3 4 5}

Is Interoception-Focused Therapy safe for humans?

The therapy, tested under names like RISE, has been rated as highly acceptable and showed good retention in studies, suggesting it is generally safe for humans. ^{1 2 4 5 6}

How does interoception-focused therapy differ from other treatments for suicidal thoughts?

Interoception-focused therapy is unique because it targets the ability to sense and understand internal body signals, which is often impaired in people with suicidal thoughts. This approach is different from traditional therapies as it aims to improve body awareness and trust, potentially reducing suicidal ideation by addressing underlying interoceptive dysfunction. ^{1 2 4 5 7}

Research Team

Eligibility Criteria

This trial is for college students aged 18 or older who have experienced suicidal thoughts or have a history of low body awareness, which can relate to eating disorders. It's not open to anyone under the age of 18.

Inclusion Criteria

I am 18 years old or older.

Low interoceptive awareness

I have had thoughts of or attempted suicide in the past.

Exclusion Criteria

I am under 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo four modules focusing on interoception, including body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others.

4 weeks

Comparator

Participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of interoception, eating pathology, and suicidality.

1 week

Treatment Details

Interventions

• Healthy Habits (Behavioral Intervention)
• Reconnecting to Internal Sensations and Experiences (Behavioral Intervention)

Trial Overview Project RISE tests a program focusing on improving body awareness and understanding emotions versus 'Healthy Habits' modules covering financial planning and hygiene. Participants are randomly assigned to one of these two approaches.

Participant Groups

Group I: Interoceptive Awareness Experimental Treatment 1 Intervention

The intervention consists of four modules that focus on multiple aspects of interoception including: body awareness, body sensations/movement, eating, health and self-care, emotional awareness, and understanding the self in relation to others.

Group II: Healthy Habits Active Control 1 Intervention

The comparator condition is called "Health Habits" and is matched for time and attention; participants complete modules related to healthy habits such as financial planning, hygiene, stretching, and healthy eating.

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Dr. Christopher B. Roberts

Auburn University

Chief Executive Officer since 2022

PhD in Chemical Engineering from the University of Notre Dame

Dr. Fred Kam

Auburn University

Chief Medical Officer since 2005

MD from the University of Alabama at Birmingham

Findings from Research

The systematic review of 22 studies involving 14,988 participants found preliminary evidence that individuals with a history of suicide attempts may have impaired interoceptive accuracy, suggesting a link between difficulties in sensing bodily states and suicidal behavior.

Interoceptive disturbances, particularly in cognitive and emotional evaluations of bodily sensations, were notably more pronounced in those who attempted suicide compared to those who only had suicidal thoughts or plans, indicating that these abnormalities could be important indicators of suicidal risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interoceptive Abnormalities and Suicidality: A Systematic Review. Hielscher, E., Zopf, R.[2021]

A study involving 276 participants in India found that interoceptive dysfunction, or difficulty recognizing internal body sensations, is linked to suicidal thoughts, highlighting a significant risk factor for suicidality in the region.

A small pilot intervention called RISE, tested on 40 participants, showed promise in improving interoceptive awareness and reducing suicidal ideation, suggesting that mindfulness-based approaches could be effective in suicide prevention efforts in India.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Feasibility Study of Reconnecting to Internal Sensations and Experiences (RISE), a Mindfulness-Informed Intervention to Reduce Interoceptive Dysfunction and Suicidal Ideation, among University Students in India. Smith, AR., Kinkel-Ram, S., Grunwald, W., et al.[2022]

Mindfulness-Based Cognitive Therapy to Prevent Suicide (MBCT-S) significantly improved attentional control in high suicide risk Veterans, as shown by better performance on E-Stroop tasks over a 6-month follow-up involving 135 participants.

Veterans receiving MBCT-S experienced improved processing of combat-related and negative emotional words, while those receiving only enhanced treatment as usual (eTAU) showed worsening attentional control, highlighting the potential efficacy of MBCT-S in reducing suicide risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attentional control may be modifiable with Mindfulness-Based Cognitive Therapy to Prevent Suicide. Chesin, MS., Keilp, JG., Kline, A., et al.[2022]

An intervention aimed at improving interoception, such as progressive muscle relaxation exercises, was found to reduce implicit identification with suicide among 136 undergraduate participants, suggesting a potential method to lower suicide risk.

A pilot study with 22 clinical participants showed that an online interoceptive awareness training program was well-received and linked to improvements in interoception, reductions in suicidal ideation, and other psychological symptoms, indicating its potential efficacy for clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconnecting to Internal Sensation and Experiences: A Pilot Feasibility Study of an Online Intervention to Improve Interoception and Reduce Suicidal Ideation. Smith, AR., Forrest, LN., Perkins, NM., et al.[2021]

The RISE intervention, which focuses on interoceptive awareness, was well-received and had a high completion rate of 85% among the 195 participants, indicating its feasibility for use among active duty service members and veterans.

While RISE significantly improved various aspects of interoceptive sensibility, such as emotional awareness and self-regulation, it did not show a measurable impact on suicidal ideation, likely due to the low baseline levels of ideation reported by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconnecting to Internal Sensations and Experiences (RISE): An online, multi-session intervention improves interoceptive sensibility for military personnel. Smith, AR., Witte, TK., Troop-Gordon, W., et al.[2023]

Individuals with suicidality, including those who have thought about, planned, or attempted suicide, exhibit significantly poorer interoceptive abilities compared to controls, with the most severe deficits observed in those who have attempted suicide.

Recent suicide attempts are more closely linked to interoceptive deficits than past attempts, suggesting that improving interoceptive awareness may be a crucial strategy in preventing suicidal behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(Dis)connected: An examination of interoception in individuals with suicidality. Forrest, LN., Smith, AR., White, RD., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Interoceptive Abnormalities and Suicidality: A Systematic Review. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Feasibility Study of Reconnecting to Internal Sensations and Experiences (RISE), a Mindfulness-Informed Intervention to Reduce Interoceptive Dysfunction and Suicidal Ideation, among University Students in India. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Attentional control may be modifiable with Mindfulness-Based Cognitive Therapy to Prevent Suicide. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Reconnecting to Internal Sensation and Experiences: A Pilot Feasibility Study of an Online Intervention to Improve Interoception and Reduce Suicidal Ideation. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Reconnecting to Internal Sensations and Experiences (RISE): An online, multi-session intervention improves interoceptive sensibility for military personnel. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

(Dis)connected: An examination of interoception in individuals with suicidality. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Examination of interoception along the suicidality continuum. [2019]