Suicide Treatment and Recovery in Integrated Behavioral Health (STRIBH) (STRIBH)

March 16, 2026 updated by: Kate Comtois, University of Washington
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment as Usual
Behavioral: Treatment as Usual in Collaborative Care or Integrated Behavioral Health
Treatment as Usual will be whatever primary care and behavioral health services are standardly implemented for adolescents or young adults experiencing suicidality
Experimental: Experimental Condition
Behavioral: Connections model
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention Measure (AIM)
Time Frame: baseline, one month, and two months
Four item scale to measure the acceptability of an intervention
baseline, one month, and two months
System Usability Scale
Time Frame: baseline, one month, and two months
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
Time Frame: baseline, one month and two months
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Columbia Suicide Severity Rating Scale Screener (C-SSRS)
Time Frame: baseline, one month and two months
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
Harkavy-Asnis Suicide Scale
Time Frame: baseline, one month and two months
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Columbia Suicide Severity Rating Scale Screener (C-SSRS)
Time Frame: baseline, one month and two months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine A Comtois, PhD, MPH, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00016520
  • P50MH129708 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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