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

NCT06803329 | Recruiting

• 2 other identifiers: D5350-W1 IK2 RX005350-01A1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Thoughts and Behaviors; Social Isolation

Keywords

Suicide; Social isolation

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention Measure (AIM)

  Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci. 2017;12(1):108. 4 items on a 5-point Likert scale from 1-5, with higher scores indicating greater acceptability, appropriateness, or feasibility. This scale has demonstrated promising psychometric properties for the monitoring and evaluation of an intervention's feasibility and acceptability. These measures are available in the public domain.

  10-20 weeks

• Intervention Appropriateness Measure (IAM)

  Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci. 2017;12(1):108. 4 items on a 5-point Likert scale from 1-5, with higher scores indicating greater acceptability, appropriateness, or feasibility. This scale has demonstrated promising psychometric properties for the monitoring and evaluation of an intervention's feasibility and acceptability. These measures are available in the public domain.

  10-20 weeks

• Feasibility of Intervention Measure (FIM)

  Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Sci. 2017;12(1):108. 4 items on a 5-point Likert scale from 1-5, with higher scores indicating greater acceptability, appropriateness, or feasibility. This scale has demonstrated promising psychometric properties for the monitoring and evaluation of an intervention's feasibility and acceptability. These measures are available in the public domain.

  10-20 weeks

Other Outcomes (3)

• Interpersonal Needs Questionnaire (INQ)

  10-20 weeks

• Beck Suicidal Ideation Scale (BSSI)

  10-20 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles & Satisfaction with Ability to Participate in Social Roles

  10-20 weeks

Study Arms (2)

Qnnections

EXPERIMENTAL

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.

Behavioral: Qnnections

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

Qnnections BEHAVIORAL

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 also receive safety planning and referrals.

Qnnections

Enhanced Usual Care BEHAVIORAL

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 elements, whereas Veterans are not guaranteed to receive all of these services if not enrolled in this study.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Behavior; Social Isolation; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Social Behavior

Study Officials

• Cindy Chang, PsyD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy Chang, PsyD

CONTACT

(786) 853-8782; Cindy.Chang4@va.gov

Colin A Depp, PhD

CONTACT

(858) 822-4251; Colin.Depp@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)