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

VA Office of Research and Development

Status: Begins enrollment this month

Conditions: Social Isolation; Suicidal Thoughts and Behaviors

Treatments: Behavioral: Qnnections; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06803329

D5350-W

1 IK2 RX005350-01A1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Qnnections

Experimental group

Description:

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.

Treatment:

Behavioral: Qnnections

Enhanced Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced Usual Care