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

March 10, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161-0002
        • Recruiting
        • VA San Diego Healthcare System, San Diego, CA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cindy Chang, PsyD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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. Veterans will also receive safety planning and referrals.
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 also receive safety planning and referrals.
Active Comparator: 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.
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 elements, whereas Veterans are not guaranteed to receive all of these services if not enrolled in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention Measure (AIM)
Time Frame: 10-20 weeks

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)
Time Frame: 10-20 weeks

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)
Time Frame: 10-20 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interpersonal Needs Questionnaire (INQ)
Time Frame: 10-20 weeks

Van Orden KA, Cukrowicz KC, Witte TK, et al. Thwarted belongingness and perceived burdensomeness: Construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychological Assessment. 2012;24(1):197-215.

15-item self-report measure that has separate scales for perceived burdensomeness and thwarted belongingness, two social disconnection constructs from the well-established Interpersonal Theory of Suicide. The INQ has demonstrated both reliability and validity, and it has been used across diverse samples of sexual minority adults (Feinstein et al., 2022).
10-20 weeks
Beck Suicidal Ideation Scale (BSSI)
Time Frame: 10-20 weeks
Beck AT, Steer, R. A. Manual for the Beck Scale for Suicide Ideation. Vol 63.; 1991.19-item interviewer-administered assessment of suicidal ideation severity. The total score may range from 0 to 38, with higher scores indicating greater suicidal ideation. The BSSI has demonstrated strong reliability and validity.
10-20 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles & Satisfaction with Ability to Participate in Social Roles
Time Frame: 10-20 weeks

Hahn EA, DeWalt DA, Bode RK, et al. New English and Spanish social health measures will facilitate evaluating health determinants. Health Psychology. 2014;33(5):490-499.

Two four-item questionnaires from the widely used PROMIS: Ability to Participate in Social Roles and Activities (PROMIS-APS) and the Satisfaction with Ability to Participate in Social Roles and Activities (PROMIS-SPS). Both subscales have scores ranging from 4-20, with higher scores indicating greater social functioning. Studies suggest these measures are responsive to change in diverse clinical populations.
10-20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Cindy Chang, PsyD, VA San Diego Healthcare System, San Diego, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5350-W
  • 1 IK2 RX005350-01A1 (Other Identifier: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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