Qnnections: Refinement and Pilot Trial of a Suicide Prevention Intervention to Increase Social Connection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Veterans who report past-month active suicidal ideation (C-SSRS [Columbia-Suicide Severity Rating Scale]
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Qnnections
BehavioralA 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 Care
BehavioralThe 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: QnnectionsExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10-20 weeks2
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.
Time frame
10-20 weeks3
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.
Time frame
10-20 weeksOther outcomes
1
Interpersonal Needs Questionnaire (INQ)
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).
Time frame
10-20 weeks2
Beck Suicidal Ideation Scale (BSSI)
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.
Time frame
10-20 weeks3
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles & Satisfaction with Ability to Participate in Social Roles
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.
Time frame
10-20 weeksSponsors and contacts
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Source ClinicalTrials.gov