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

NCT05172609 | Completed Results DMC

• 1 other identifier: 356336
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Implementation Science

Outcome Measures

Primary Outcomes (2)

• Clinician Perception of EBIS Acceptability for Clinical Practice at Time 4, 12 Weeks After Completing Training

  Acceptability of EBIS was measured with the Acceptability of Intervention Measure (AIM), a 4-item, psychometrically-validated measure that indexes the extent to which stakeholders believe an implementation strategy is acceptable. Items on the AIM are rated on a 5-point Likert scale (Range = 4-20) and higher scores indicate greater acceptability.

  Time 4: 12 weeks after completing training

• Clinician Perception of EBIS Feasibility and Utility for Clinical Practice at Time 4, 12 Weeks After Completing Training

  Feasibility of EBIS was measured with the Feasibility of Intervention Measure (FIM), a 4-item measure that indexes the extent to which an implementation strategy is perceived as feasible. Items on the FIM are rated on a 5-point Likert scale (Range = 4-20) and higher scores indicate greater acceptability.

  Time 4: 12 weeks after completing training

Secondary Outcomes (4)

• Clinician Anxiety at 4 Timepoints Across 12 Weeks

  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.

• Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks

  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

• Screening Use at 3 Timepoints Across 12 Weeks

  Time 1: baseline measures completed before the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training

• Safety Planning Intervention Use (Fidelity) at Time 3 (Two Weeks After Completing the Training) and Time 4 (12 Weeks After Completing the Training)

  Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training

Study Arms (2)

Exposure Based Implementation Strategy (EBIS)

EXPERIMENTAL

EBIS is informed by the latest science in exposure theory, borrowing heavily from brief exposure-based treatments that can be delivered in a single session. We anticipate that EBIS will occur in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention; however, the final version will depend on the outcomes of the preparatory phases of this study. Clinicians assigned to the EBIS arm will also receive all elements of IAU.

Behavioral: Exposure Based Implementation Strategy (EBIS)

Implementation as Usual (IAU)

ACTIVE COMPARATOR

Gold-standard IAU for SSAIs typically comprises pre-implementation preparation, didactic training, knowledge tests, experiential role plays, ongoing expert consultation, and providing certification status to clinicians who attain established benchmarks. Pre-implementation preparation will include provision of materials. Didactic training will occur in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one will consist of materials we previously developed based on community clinician feedback. Part two will follow established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also will include supports for electronic health record integration (e.g., previously developed templates). After training, clinicians will receive 8 weeks of expert consultation to discuss implementation barriers and receive more role play practice.

Behavioral: Implementation as Usual (IAU)

Interventions

Exposure Based Implementation Strategy (EBIS) BEHAVIORAL

EBIS will include psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.

Exposure Based Implementation Strategy (EBIS)

Implementation as Usual (IAU) BEHAVIORAL

IAU will consist of standard didactic training and ongoing consultation activities for enrolled clinicians

Implementation as Usual (IAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Practicing mental health clinicians who provide direct mental health services to a treatment-seeking population
• Proficient in the English language
• Have access to a computer with internet connectivity

You may not qualify if:

• Participants will be excluded if they do not see any mental health patients that are at risk for suicide (e.g., they screen out high-risk patients for their individual practice).

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Department of Psychiatry

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Becker-Haimes EM, Brady M, Jamison J, Jager-Hyman S, Reilly ME, Patel E, Brown GK, Mandell DS, Oquendo MA. An exposure-based implementation strategy to decrease clinician anxiety about implementing suicide prevention evidence-based practices: protocol for development and pilot testing (Project CALMER). Implement Sci Commun. 2023 Nov 24;4(1):148. doi: 10.1186/s43058-023-00530-3.

  PMID: 38001478 BACKGROUND

Results Point of Contact

• Title: Dr. Emily Becker-Haimes
• Organization: University of Pennsylvania

emily.haimes@pennmedicine.upenn.edu

215-573-5614

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: December 29, 2021
• Study Start: March 29, 2023
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-07

Locations

US (1)