Clinical trial NCT06700993: Suicide Treatment and Recovery in Integrated Behavioral Health (STRIBH)
Official title: Suicide Treatment and Recovery in Integrated Behavioral Health (STRIBH)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation and Behavior
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: National Institute of Mental Health (NIMH)
First posted: 2024-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Partnering primary care clinics will recruit study participants and provide them treatment as usual in their Collaborative Care or other Integrated Behavioral Health program. This will be followed by training in the experimental intervention, the Connections model. Trained clinicians will recruit study participants and provide them with the Connections model in their Collaborative Care or other Integrated Behavioral Health program. This is a pilot study in preparation for a larger stepped wedge or other cluster randomized trial.
Primary purpose: TREATMENT

Brief summary: The suicide rate has increased 28% over the past two decades while heart disease, diabetes, and cancer mortality has declined. Starting in 2011, new standards have led to improved adoption and reach of suicide risk surveillance in primary and specialty care. Treatment, however, has lagged. Collaborative Care in primary care settings has demonstrated small but significant reductions in suicidal ideation when a recognized psychological treatment model is included but not when Collaborative Care only includes medication management, suggesting that improvements to psychological treatments in Collaborative Care could further improve suicide outcomes. Developed in a series of conferences in Aeschi Switzerland, the "Aeschi Model" based on the clinical narrative has become an established approach to suicide care endorsed by leaders across the suicidology field - including the developers of major evidence-based suicide interventions. With support from the Methods Core, this Exploratory (R34) study of the University of Washington Suicide Care Research Center (SCRC) will co-design and pilot test the "Connections model" that integrates Aeschi Model with Collaborative Care or other Integrated Behavioral Health with adolescent and young adult patients (age 13-30 years) who do not require immediate crisis intervention. This study will focus on increasing therapeutic alliance - a key proposed mechanism of the Aeschi approach and the SCRC. The aims of this study are to partner with diverse primary care clinics to conduct a pilot test of the Connections model compared to treatment as usual in six primary care clinics to determine (a) usability and acceptability of the intervention components to patients and providers and (b) the components' potential impact on therapeutic alliance and patient and provider self-efficacy, and (c) potential impact on suicidal outcomes. Given the strong theoretical basis for both the Aeschi Model and Collaborative Care, this proposal has the potential to develop a high impact intervention that will both reduce suicide risk and improve therapeutic alliance - potentially without any increase in the quantity of care.

Detailed description: This study will focus on increasing therapeutic alliance - a key proposed mechanism of the Aeschi approach and the SCRC. The aims of this study are to partner with diverse primary care clinics to conduct a pilot test of the Connections model compared to treatment as usual in six primary care clinics to determine (a) usability and acceptability of the intervention components to patients and providers and (b) the components' potential impact on therapeutic alliance and patient and provider self-efficacy, and (c) potential impact on suicidal outcomes. Given the strong theoretical basis for both the Aeschi Model and Collaborative Care, this proposal has the potential to develop a high impact intervention that will both reduce suicide risk and improve therapeutic alliance - potentially without any increase in the quantity of care.

Eligibility criteria: Inclusion Criteria:

* 13-30 years of age, experiencing suicidal thoughts or attempted suicide in the past year, not requiring immediate crisis care (as determined by the UW Primary Care team), not enrolled in specialty behavioral health treatment, can read one of the 4 most common languages in Seattle (English, Spanish, Chinese, or Vietnamese), enrolled in a primary care clinic with an integrated behavioral health provider available to see them, and ability to consent to participate.

Exclusion Criteria:

* any clinical medical/psychiatric condition, severity of that condition, or life situation that, in the opinion of the primary care or research team, compromises safe and voluntary study participation (e.g., high risk for suicide requiring transfer to higher level of care; physically aggressive, custody conflict)

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: baseline, one month, and two months
measure: System Usability Scale
timeFrame: baseline, one month, and two months
measure: Harkavy-Asnis Suicide Scale
timeFrame: baseline, one month and two months
Secondary outcomes:
Other outcomes:
measure: The Columbia Suicide Severity Rating Scale Screener (C-SSRS)
timeFrame: baseline, one month and two months
Locations:
Study officials:
affiliation: University of Washington
name: Katherine A Comtois, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: