NCT05172609

An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety Around Suicide Prevention

An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety About Delivering Suicide Prevention Evidence-Based Practices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Study objectives are to design and pilot test a novel, exposure-based implementation strategy (EBIS) directly targeting clinician anxiety and low self-efficacy for use of evidence-based suicide screening, assessment, and intervention (SSAI) strategies with patients at risk for suicide in community settings. Early phases of this study will develop the EBIS in partnership with community clinicians (n = 15). The last phase of this study is a pilot clinical trial in which 40 community mental health clinicians will be randomized to receive either implementation as usual (IAU) or IAU+EBIS.

Detailed description

This exploratory project brings together an interdisciplinary team to design and pilot-test an exposure-based implementation strategy (EBIS) to target clinician-level anxiety about suicide screening, assessment, and intervention (SSAI) use. We will test the effect of EBIS as an implementation strategy to augment Implementation as Usual (IAU) to enhance SSAI implementation in community mental health settings. Specifically, this study first will use participatory design methods to develop and refine EBIS in collaboration with a stakeholder advisory board of clinicians, administrators, and content experts. This study then will further iteratively refine EBIS with up to 15 clinicians in a pilot field test, using rapid cycle prototyping, in collaboration with the INSPIRE Methods Core. Clinicians in Aim 2 will also provide qualitative feedback on EBIS' ability to mitigate anxiety and increase self-efficacy to deliver SSAIs to optimize our ability to engage target mechanisms of clinician anxiety. In the final phase, this study will test the refined EBIS in a pilot implementation trial in which 40 community mental health clinicians will be randomized to receive either IAU or EBIS+IAU. Primary clinical trial dependent variables are EBIS acceptability and feasibility, measured through questionnaires, interviews, and recruitment and retention statistics; this pilot trial is not intended to be powered to detect effects. Secondary outcomes are preliminary effectiveness of EBIS on clinician-level implementation outcomes (SSAI adoption), and engagement of target implementation mechanisms (clinician anxiety and self-efficacy related to SSAI use), assessed via mixed methods. Aim 1 did not include data collection from study participants. Activities in this aim only included refinement with the advisory board members who were not considered study participants. Data collected in Aim 2 was largely descriptive and qualitative to inform EBIS development and refinement activities. We are reporting Aim 3 data which included pilot randomization with clinicians. Data was collected at the following timepoints: Time 1: baseline measures completed before the training; Time 2: immediately after completing the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training.

Conditions

• Implementation Science

Interventions

Type	Name	Description
BEHAVIORAL	Exposure Based Implementation Strategy (EBIS)	EBIS will include psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.
BEHAVIORAL	Implementation as Usual (IAU)	IAU will consist of standard didactic training and ongoing consultation activities for enrolled clinicians

Timeline

• Start date: 2023-03-29
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2021-12-29
• Last updated: 2025-08-13
• Results posted: 2025-08-13

Locations

1 site across 1 country: United States