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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new group-based program called Qnnections, designed to assist LGBTQ+ Veterans struggling with suicidal thoughts or who have recently attempted suicide. The goal is to determine if Qnnections can enhance social connections and overall well-being alongside standard mental health care. Participants will be divided into two groups: one receiving Qnnections and the other receiving enhanced usual care, which includes safety planning and referrals. This trial suits LGBTQ+ Veterans who have recently experienced suicidal thoughts or behaviors and are open to updating their safety plan. As an unphased trial, it offers a unique opportunity for participants to contribute to innovative mental health solutions tailored for LGBTQ+ Veterans.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that group activities, such as Qnnections, can enhance feelings of connection and may benefit individuals with suicidal thoughts. Although specific safety data for Qnnections is not yet available, the treatment includes standard safety planning, which has proven effective in reducing suicidal thoughts and improving coping mechanisms. This suggests the treatment is likely safe and well-received. Participants will also receive safety planning and referrals alongside Qnnections, practices that are common and generally safe in mental health care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for suicidal ideation, which often include medication and traditional therapy, Qnnections offers a novel, group-based intervention specifically designed for LGBTQ+ Veterans. This approach enhances standard VA mental health services by providing a supportive community setting, safety planning, and personalized referrals. Researchers are excited about Qnnections because it directly addresses the unique challenges faced by LGBTQ+ individuals, potentially leading to more effective prevention and support tailored to their needs.

What evidence suggests that Qnnections is effective for preventing suicide among LGBTQ+ Veterans?

Research shows that regular social contact can help reduce suicidal thoughts. In this trial, participants may receive the Qnnections program, which aims to improve social connections and functioning, especially for LGBTQ+ Veterans. While specific data on Qnnections is still being gathered, similar programs have shown promise in lowering suicide risk. Other studies have found that group-based suicide prevention programs can effectively reduce suicide rates. This approach relies on evidence that social support is crucial for mental health and can help prevent suicide. ^{2 6 7 8 9}

Who Is on the Research Team?

Cindy Chang, PsyD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-suicidal-thoughts-and-behaviors-10-2025-93d9f

Qnnections for Suicidal Ideation · Info for Participants What data supports the effectiveness of the treatment Qnnections for suicidal ideation? The research suggests that treatments involving ongoing contact ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092896/

Improving Suicide Prevention Through Evidenced-Based ... Repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT) reduced suicidal ideation, but samples were too small to evaluate ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S016517812400088X

The effectiveness of a suicide prevention program in ... A primary care suicide prevention program supported by community public health resources, was effective in reducing suicide rates.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31078311/

Effectiveness of suicide prevention interventions Conclusions: Suicide prevention interventions are effective in preventing completed and attempted suicides and should be widely implemented. Further research ...

5. researchgate.net researchgate.net/figure/Overview-of-the-four-studies-included-in-quantitative-syntheses_tbl2_376981741

Overview of the four studies included in quantitative ... Aim(s): This review aimed to determine the effectiveness of digital interventions designed to address suicidal ideation and behaviors and the impacts of age, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06803329

Qnnections: Refinement and Pilot Trial of a Suicide ... A novel group-based suicide prevention intervention that augments standard VA mental health services for LGBTQ+ Veterans with current suicidal thoughts or ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124000350

Digital safety plan effectiveness and use: Findings from a ... Significant reductions in suicidal ideation and increases in suicide-related coping were found over three months. Higher suicide-related coping at three months ...

9. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/suicidal-ideation

Suicidal Ideation clinical trials at University of California Health This is a prospective clinical trial to confirm the effectiveness of bilateral accelerated theta burst stimulation (aTBS) on suicidal ideation ( ...