Social Isolation, Suicidal Thoughts and Behaviors
Conditions
Keywords
Suicide, Social isolation
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.
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.
Interventions
BEHAVIORALQnnections
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.
BEHAVIORALEnhanced 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | 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) | 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) | 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. |
Countries
United States
Contacts
CONTACTCindy Chang, PsyD
CONTACTColin A Depp, PhD
PRINCIPAL_INVESTIGATORCindy Chang, PsyD
VA San Diego Healthcare System, San Diego, CA
Outcome results
None listed