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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH129708 | U.S. NIH Grant/Contract | View source |
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The study was withdrawn before enrollment due to changes in the scope and timeline following sponsor guidance. The team determined there was insufficient time to conduct the planned pilot testing and will instead focus on refining the intervention.
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Condition | Experimental |
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| Treatment as Usual | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as Usual in Collaborative Care or Integrated Behavioral Health | Behavioral | Treatment as Usual will be whatever primary care and behavioral health services are standardly implemented for adolescents or young adults experiencing suicidality |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | Four item scale to measure the acceptability of an intervention | baseline, one month, and two months |
| System Usability Scale | The System Usability Scale is a 10-item measure of the usability of a tool, and is considered the industry standard for measuring usability in the UCD field. A SUS score of 80 is generally seen as a threshold for a highly usable system. | baseline, one month, and two months |
| Harkavy-Asnis Suicide Scale | This measure assesses the frequency of suicidal ideation on a 5-point Likert scale, with 0 indicating "never" and 4 indicating "most or all of the time". Higher scores reflect higher severity and frequency of suicidal ideation. | baseline, one month and two months |
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| Measure | Description | Time Frame |
|---|---|---|
| The Columbia Suicide Severity Rating Scale Screener (C-SSRS) | A measure of suicidal thoughts and behaviors. Suicide ideation is rated on a scale of 1 to 5, with higher numbers reflecting more severe ideation. Suicidal behaviors are count measures, with higher numbers reflecting more attempts. | baseline, one month and two months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine A Comtois, PhD, MPH | University of Washington | Principal Investigator |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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All outcomes are completed through surveys so the research team is not blinded, per se, but they are not involved in the participant responses.
| Connections model | Behavioral | The Connections model applies the Aeschi Model of suicide care to Collaborative Care or other Integrated Behavioral Health by centering the patient's clinical narrative, focusing treatment on the patient's unique drivers of suicide, and maximizing collaboration while maintaining the standards of suicide assessment and management expected by accrediting bodies. |
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