Suicide Treatment and Recovery in Integrated Behavioral Health (STRIBH)

NCT06700993 | Withdrawn

• 2 other identifiers: STUDY00016520P50MH129708
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Suicidal Ideation and Behavior

Outcome Measures

Primary Outcomes (3)

• 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

Other Outcomes (1)

• The Columbia Suicide Severity Rating Scale Screener (C-SSRS)

  baseline, one month and two months

Study Arms (2)

Experimental Condition

EXPERIMENTAL

Behavioral: Connections model

Treatment as Usual

ACTIVE COMPARATOR

Behavioral: Treatment as Usual in Collaborative Care or Integrated Behavioral Health

Interventions

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

Treatment as Usual

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.

Experimental Condition

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• Kaiser Permanente: collaborator
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Suicidal Ideation; Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Study Officials

• Katherine A Comtois, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes are completed through surveys so the research team is not blinded, per se, but they are not involved in the participant responses.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioral Sciences

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03