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Recruiting NCT06803329

Qnnections: Refinement and Pilot Trial of a Suicide Prevention Intervention to Increase Social Connection

No phase Interventional Suicidal Thoughts and Behaviors Social Isolation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Qnnections, Enhanced Usual Care.
Who it may be relevant to
Registry conditions: Suicidal Thoughts and Behaviors, Social Isolation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Qnnections: A Novel Suicide Prevention Intervention for Increasing Social Connection Among LGBTQ+ Veterans

Overview

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.

Detailed description

Theoretical and empirical research consistently identifies perceived burdensomeness and thwarted belongingness as suicide-specific risk factors. This proposal refines and pilots Qnnections, a novel suicide prevention intervention which aims to increase social connection and functioning through improving belongingness and reducing burdensomeness. Phase I (1.5 years) focuses on intervention refinement of Qnnections with a Veteran Advisory Board (n = 8) and expert mentors. In its current form, Qnnections is a 10-week group-based intervention intended to augment Veterans Affairs (VA) suicide prevention efforts, using a cognitive behavioral framework to target social disconnection. After refinement by mentors and Veterans with lived experience, a pilot open trial (n = 10) will engage Veterans and gather acceptability data. Following refinement from Phase 1, Phase 2 (3.5 years) includes a pilot randomized feasibility and acceptability trial (n = 48), with participants randomized to Qnnections (10 group sessions, safety plan, referrals) or an Enhanced Usual Care condition that contains elements of standard VA suicide prevention (safety plan, referrals). Veteran participants in both phases will complete quantitative assessments at baseline, mid-treatment, post-treatment, and ten-week follow-up. Qualitative data collection will occur at post-treatment. The focus is feasibility and acceptability of Qnnections and of study procedures.

Interventions

  • Behavioral Qnnections
    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. Informed by the empirically-supported theoretical framework of the interpersonal theory of suicide and prior work tailoring interventions for minority stress, Qnnections is a structured 10-week group that uses a cognitive behavioral framework to target perceived burdensomeness and thwarted belongingness. Veterans will
  • Behavioral Enhanced Usual Care
    The active control condition includes: 1) VA Safety Planning Intervention and 2) referrals to VA and non-VA services relevant to the individual. The safety plan will be conducted by Dr. Chang, a licensed psychologist. Therefore, EUC only differs from the Qnnections condition as it does not have the 10-session Qnnections intervention. EUC is intended to include elements of VA suicide prevention standard practice. The control condition is considered enhanced as all participants will receive these

Primary outcome measures

  • Acceptability of Intervention Measure (AIM) [Time frame: 10-20 weeks]
  • Intervention Appropriateness Measure (IAM) [Time frame: 10-20 weeks]
  • Feasibility of Intervention Measure (FIM) [Time frame: 10-20 weeks]

Eligibility criteria

Inclusion criteria

  • Veterans who report past-month active suicidal ideation (C-SSRS \[Columbia-Suicide Severity Rating Scale\]

\-- or past-3-month suicidal behavior;

  • LGBTQ+ or other minoritized gender or sexual identity;
  • Have a mental health point-of-contact (e.g., Suicide Prevention Coordinator, Mental Health Treatment Coordinator);
  • Willing to complete or update safety plan.

Exclusion criteria

  • cannot provide informed consent;
  • imminent psychiatric hospitalization;
  • current or planned participation in residential/intensive outpatient program that would interfere study participation;
  • in a conservatorship; and
  • has participated in any previous parts of the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • VA San Diego Healthcare System, San Diego, CA — San Diego

Identifiers

NCT: NCT06803329 · D5350-W · 1IK2RX005350-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗