Qnnections for Suicidal Ideation

(Qnnections Trial)

Overseen By Cindy Chang, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Imminent hospitalization, Conservatorship, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

66 Participants Needed

Trial Summary

What is the purpose of this trial?

Despite the high risk of suicide among LGBTQ+ Veterans, there is currently no suicide-focused intervention for this population. This study will refine and pilot Qnnections, a novel group-based suicide prevention intervention that aims to increase social connection and functioning in this population. The project will involve Veterans with lived experience in further refining Qnnections, and then will examine feasibility and acceptability of Qnnections and of study procedures in a pilot randomized clinical trial.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Qnnections for suicidal ideation?

The research suggests that treatments involving ongoing contact, like telephone follow-ups, and structured interventions, such as the Collaborative Assessment and Management of Suicidality (CAMS), can improve outcomes for people with suicidal thoughts. These approaches help maintain treatment engagement and address specific psychological needs, which may be relevant to the effectiveness of Qnnections. ^{1 2 3 4 5}

What safety data exists for Qnnections in humans?

The research highlights the importance of monitoring drugs for suicide-related adverse events, but it does not provide specific safety data for Qnnections. It emphasizes the need for clear definitions and consistent reporting of adverse events in studies related to suicide prevention. ^{6 7 8 9 10}

How does the treatment Qnnections for suicidal ideation differ from other treatments?

Qnnections appears to involve a novel approach related to quorum sensing (a type of bacterial communication) and quorum quenching (a method to disrupt this communication), which is different from traditional treatments for suicidal ideation that typically focus on psychological or pharmacological interventions. ^{11 12 13 14 15}

Research Team

Cindy Chang, PsyD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

This trial is for LGBTQ+ Veterans experiencing depression, social isolation, or suicidal thoughts. Participants should be interested in a group-based intervention aimed at increasing social connections tailored to their unique experiences.

Inclusion Criteria

Veterans who report past-month active suicidal ideation (C-SSRS [Columbia-Suicide Severity Rating Scale] or past-3-month suicidal behavior

Willing to complete or update safety plan

LGBTQ+ or other minoritized gender or sexual identity

Exclusion Criteria

Imminent psychiatric hospitalization

Current or planned participation in residential/intensive outpatient program that would interfere study participation

Has participated in any previous parts of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Refinement

Refinement of Qnnections with a Veteran Advisory Board and expert mentors

1.5 years

Pilot Open Trial

Engage Veterans and gather acceptability data for Qnnections

10 weeks

10 group sessions

Pilot Randomized Trial

Participants randomized to Qnnections or Enhanced Usual Care to assess feasibility and acceptability

3.5 years

10 group sessions, safety plan, referrals

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Quantitative assessments at baseline, mid-treatment, post-treatment, and ten-week follow-up

Treatment Details

Interventions

• Qnnections

Trial Overview The study tests 'Qnnections', a new group suicide prevention program against Enhanced Usual Care. It focuses on improving social ties and functioning among LGBTQ+ Veterans at risk of suicide.

Participant Groups

Group I: Qnnections Experimental Treatment 1 Intervention

A novel group-based suicide prevention intervention that augments standard VA mental health services for LGBTQ+ Veterans with current suicidal thoughts or recent suicidal behavior. Veterans will also receive safety planning and referrals.

Group II: Enhanced Usual Care Active Control 1 Intervention

The active control condition includes: 1) VA Safety Planning Intervention and 2) referrals to VA and non-VA services relevant to the individual.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Emphasizing early intervention and ongoing low-intensity contact with individuals at risk of suicide can be more effective than solely focusing on those deemed 'highest risk', suggesting a shift in treatment strategy.

The use of advanced interactive computer programs can enhance screening and training for healthcare providers, improving access to mental health services and continuity of care for suicidal individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention in a treatment setting. Litman, RE.[2022]

A quality improvement project involving 134 veterans hospitalized for suicidal thoughts showed that a new single-session suicide-focused psychoeducation group was highly acceptable and perceived as useful by participants.

After attending the group, veterans reported increased hope and motivation to learn coping skills for their suicidal thoughts, indicating the potential effectiveness of this intervention in an inpatient setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding suicide: Development and pilot evaluation of a single-session inpatient psychoeducation group. Gebhardt, HM., Ammerman, BA., Carter, SP., et al.[2022]

The study analyzed responses from 49 patients regarding helpful aspects of their treatment for suicidal risk, leading to the development of a reliable coding system to identify major themes in their experiences.

Insights gained from 52 patients on what they learned from their clinical care can inform future suicide-specific treatments, highlighting the importance of patient feedback in improving therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. Schembari, BC., Jobes, DA., Horgan, RJ.[2022]

In a study of 104 psychiatric inpatients, those receiving the Collaborative Assessment and Management of Suicidality (CAMS) intervention showed significantly greater improvements in depression, suicidal ideation, and overall well-being compared to those receiving standard treatment.

While all patients improved during their stay, the benefits of CAMS were not maintained at the 6-month follow-up, indicating that ongoing support may be necessary to sustain the advantages of specialized interventions for suicidal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled comparison trial of the Collaborative Assessment and Management of Suicidality (CAMS) in an inpatient setting: Outcomes at discharge and six-month follow-up. Ellis, TE., Rufino, KA., Allen, JG.[2019]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

A pharmacovigilance analysis of over 85,000 cases from the FDA's Adverse Event Reporting System identified specific drug combinations and indications that may increase the risk of suicide, highlighting the complexity of suicide risk factors.

The study suggests that certain demographic groups may be more affected by these drug combinations, indicating a need for further research to validate these findings and improve suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mining Drugs and Indications for Suicide-Related Adverse Events. Ding, T., Chen, ES.[2020]

The study presents a consensus framework for assessing the risk of treatment-related suicidal ideation and behavior (SIB) during drug development, addressing a growing concern among health authorities.

This framework considers various factors, including the chemical and pharmacological properties of drugs, patient populations, and regulatory precedents, to better identify and manage SIB risks in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated risk assessment of suicidal ideation and behavior in drug development. Muller, PY., Dambach, D., Gemzik, B., et al.[2022]

References

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

Suicide prevention in a treatment setting. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Telephone contact with patients in the year after a suicide attempt: does it affect treatment attendance and outcome? A randomised controlled study. [2020]

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

Understanding suicide: Development and pilot evaluation of a single-session inpatient psychoeducation group. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

A controlled comparison trial of the Collaborative Assessment and Management of Suicidality (CAMS) in an inpatient setting: Outcomes at discharge and six-month follow-up. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review of validated suicide outcome classification in observational studies. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]

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

Mining Drugs and Indications for Suicide-Related Adverse Events. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Integrated risk assessment of suicidal ideation and behavior in drug development. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Validation of suicide and self-harm records in the Clinical Practice Research Datalink. [2022]

11. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Quorum sensing inhibitors as anti-biofilm agents. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Quorum quenching in anaerobic membrane bioreactor for fouling control. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Quorum sensing and quenching in membrane bioreactors: Opportunities and challenges for biofouling control. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Wireless electrical-molecular quantum signalling for cancer cell apoptosis. [2023]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Quorum Sensing Activity of Probiotics: The Mechanism and Role in Food and Gut Health. [2023]