Clinical trial NCT06803329: Qnnections: Refinement and Pilot Trial of a Suicide Prevention Intervention to Increase Social Connection
Official title: Qnnections: A Novel Suicide Prevention Intervention for Increasing Social Connection Among LGBTQ+ Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Thoughts and Behaviors
Social Isolation
Keywords: Suicide
Social isolation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-01-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In Phase I (1.5 years), a pilot open trial (n = 10) will engage Veterans at elevated risk for suicide 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).
Primary purpose: OTHER

Brief summary: 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.

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.

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 10-20 weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 10-20 weeks
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 10-20 weeks
Secondary outcomes:
Other outcomes:
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: 10-20 weeks
measure: Beck Suicidal Ideation Scale (BSSI)
timeFrame: 10-20 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles & Satisfaction with Ability to Participate in Social Roles
timeFrame: 10-20 weeks
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Cindy Chang, PsyD
role: PRINCIPAL_INVESTIGATOR
References: