Thinking of joining a study?

Register your interest

NCT06803329 | NOT YET RECRUITING | Suicidal Thoughts and Behaviors


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

VA Office of Research and Development

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.

Condition or disease

Suicidal Thoughts and Behaviors

Social Isolation

Intervention/treatment

Qnnections

Enhanced Usual Care

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 66 participants
Masking : SINGLE
Masking Description : Assessors will be masked with regard to intervention condition to avoid bias, and participants will be instructed not to reveal their intervention condition. In Phase II, open-ended surveys will be used to collect qualitative data at post-treatment to allow for data collection without unmasking assessors.
Primary Purpose : OTHER
Official Title : Qnnections: A Novel Suicide Prevention Intervention for Increasing Social Connection Among LGBTQ+ Veterans
Actual Study Start Date : 2025-10-01
Estimated Primary Completion Date : 2030-09-30
Estimated Study Completion Date : 2030-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT06803329


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, California

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States, 92161-0002

Loading...