Suicidal Thoughts and BehaviorsQnnectionsNCT06803329
Qnnections: Refinement and Pilot Trial of a Suicide Prevention Intervention to Increase Social Connection
A study testing Qnnections in people with Suicidal Thoughts and Behaviors and Social Isolation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Thoughts and Behaviors, Social Isolation
- What is being tested?
- Qnnections
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Cindy Chang, PsyD, 786-853-8782, Cindy.Chang4@va.gov
Colin A Depp, PhD, (858) 822-4251, Colin.Depp@va.gov
About this study
Official title: Qnnections: A Novel Suicide Prevention Intervention for Increasing Social Connection Among Vulnerable 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.
Read the 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.
- Conditions
- Suicidal Thoughts and Behaviors, Social Isolation
- Being tested
- Qnnections, Enhanced Usual Care
- Keywords
- Suicide, Social isolation
- Medical subject headings
- Suicidal Ideation, Behavior, Social Isolation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QnnectionsBehavioural
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.
Enhanced Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Mar 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Thoughts and BehaviorsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cindy Chang, PsyD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803329
- Sponsor's protocol ID
- D5350-W
- Other IDs
- 1IK2RX005350-01A1
- Acronym
- Qnnections
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qnnections: A Novel Suicide Prevention Intervention for Increasing Social Connection Among Vulnerable Veterans
- ClinicalTrials.gov ID
- NCT06803329
- Acronym / sponsor ID
- Qnnections / D5350-W
- Conditions
- Suicidal Thoughts and Behaviors, Social Isolation
- Keywords
- Suicide, Social isolation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Qnnections | Experimental | Behavioral: QnnectionsA 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. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareThe active control condition includes: 1) VA Safety Planning Intervention and 2) referrals to VA and non-VA services relevant to the individual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QnnectionsA 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. | Behavioural | Qnnections |
| Enhanced Usual CareThe 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. | Behavioural | Enhanced Usual Care |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cindy Chang, PsyD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qnnections in people with Suicidal Thoughts and Behaviors and Social Isolation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cindy Chang, PsyD ((786) 853-8782, Cindy.Chang4@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: 10-20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.