Trial Outcomes & Findings for An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety Around Suicide Prevention (NCT NCT05172609)

Last Updated: 2025-08-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

Time 4: 12 weeks after completing training

Results posted on

2025-08-13

Participant Flow

We are reporting Aim 3 data which included pilot randomization with clinicians. Data from Aims 1 and 2 are not included as these aims were largely preparatory. Aim 3 data was collected at baseline before the training (Time 1), after the training (Time 2), two weeks after the training (Time 3), and 12 weeks after the training (Time 4). These clinician participants were recruited from 5 agencies between July to August 2023.

42 participants were consented into the study. 3 dropped out before completing any study activities due to time constraints or a change in eligibility status. 39 completed baseline measures before randomization (time 1). Of the 39, 3 dropped out due to timing constraints or change in eligibility status. 36 were randomized to condition by training type.

Participant milestones

Participant milestones
Measure	Exposure Based Implementation Strategy (EBIS) 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. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.	Implementation as Usual (IAU) Gold-standard IAU for suicide screening, assessing, and intervening (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 included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians
Time 2 STARTED	18	18
Time 2 COMPLETED	18	18
Time 2 NOT COMPLETED	0	0
Time 3 STARTED	18	18
Time 3 COMPLETED	17	17
Time 3 NOT COMPLETED	1	1
Time 4 STARTED	17	17
Time 4 COMPLETED	16	16
Time 4 NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Exposure Based Implementation Strategy (EBIS) 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. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.	Implementation as Usual (IAU) Gold-standard IAU for suicide screening, assessing, and intervening (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 included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians
Time 3 Elected not to continue with study due to time constraints	1	1
Time 4 Elected not to continue with study due to personal reasons unrelated to the study	1	0
Time 4 Elected not to continue with study due to time constraints	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled, Not Yet Randomized n=42 Participants Participant information reported below include Aim 3 data captured before participants were randomized into EBIS or IAU conditions. After participants consented to study participation, they completed baseline measures. Participants were randomized after all participants were consented 1:1 by training date (EBIS or IAU).
Age, Continuous	37.0 years STANDARD_DEVIATION 10.85 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Time 4: 12 weeks after completing training

Population: After completing baseline measures, participants were randomized to training condition. By the end of the 12 week trial, 2 participants had dropped out of each study condition (n = 4).

Outcome measures

Outcome measures
Measure	Exposure Based Implementation Strategy (EBIS) n=16 Participants 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. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.	Implementation as Usual (IAU) n=16 Participants 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 included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians
Clinician Perception of EBIS Acceptability for Clinical Practice at Time 4, 12 Weeks After Completing Training	4.55 units on a scale Standard Deviation .53	4.56 units on a scale Standard Deviation .46

PRIMARY outcome

Timeframe: Time 4: 12 weeks after completing training

Population: After completing baseline measures, participants were randomized to training condition. By the end of the 12 week trial, 2 participants had dropped out of each study condition (n = 4).

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.

Outcome measures

Outcome measures
Measure	Exposure Based Implementation Strategy (EBIS) n=16 Participants 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. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.	Implementation as Usual (IAU) n=16 Participants 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 included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians
Clinician Perception of EBIS Feasibility and Utility for Clinical Practice at Time 4, 12 Weeks After Completing Training	4.59 units on a scale Standard Deviation .48	4.63 units on a scale Standard Deviation .47

SECONDARY outcome

Timeframe: 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.

Population: This measure was completed across four timepoints. 2 participants dropped out of the study after post-intervention measures. 2 additional participants dropped out after two week follow up measures

Clinician anxiety was assessed via 10-point Subjective Units of Distress (SUDS), a 10-point Likert rating of subjective distress where 1 = Not at all Distressed and 10 = Very Distressed. Clinicians rated their anxiety on screening and safety planning separately.

Outcome measures

Outcome measures
Measure	Exposure Based Implementation Strategy (EBIS) n=18 Participants 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. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.	Implementation as Usual (IAU) n=18 Participants 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 included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians
Clinician Anxiety at 4 Timepoints Across 12 Weeks Time 1: SUDS, screening	4.28 units on a scale Standard Deviation 1.78	3.94 units on a scale Standard Deviation 2.36
Clinician Anxiety at 4 Timepoints Across 12 Weeks Time 1: SUDS, planning	4.67 units on a scale Standard Deviation 2.30	4.28 units on a scale Standard Deviation 2.11
Clinician Anxiety at 4 Timepoints Across 12 Weeks Time 2: SUDS, screening	5.06 units on a scale Standard Deviation 2.01	3.94 units on a scale Standard Deviation 2.29
Clinician Anxiety at 4 Timepoints Across 12 Weeks Time 2: SUDS, planning	5.50 units on a scale Standard Deviation 2.38	4.33 units on a scale Standard Deviation 2.97
Clinician Anxiety at 4 Timepoints Across 12 Weeks Time 3: SUDS, screening	4.59 units on a scale Standard Deviation 2.00	4.06 units on a scale Standard Deviation 2.14
Clinician Anxiety at 4 Timepoints Across 12 Weeks Time 3: SUDS, planning	4.76 units on a scale Standard Deviation 2.11	4.29 units on a scale Standard Deviation 2.57
Clinician Anxiety at 4 Timepoints Across 12 Weeks Time 4: SUDS, screening	3.75 units on a scale Standard Deviation 1.53	3.25 units on a scale Standard Deviation 1.77
Clinician Anxiety at 4 Timepoints Across 12 Weeks Time 4: SUDS, planning	3.50 units on a scale Standard Deviation 1.79	3.81 units on a scale Standard Deviation 2.43

SECONDARY outcome

Self-efficacy was measured via responses to two statements on a 7-point scale measuring clinicians' self-efficacy to use SSAIs, using established question stems from behavioral science (e.g., "If I really wanted to, I could screen every patient I see for suicide risk"). Self-efficacy was assessed separately for clinician self-efficacy for suicide screening and for use of the Safety Planning Intervention. Higher scores indicate greater self-efficacy. Scores were averaged for analysis (Range = 1 - 7).

Outcome measures

Outcome measures
Measure	Exposure Based Implementation Strategy (EBIS) n=18 Participants 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. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.	Implementation as Usual (IAU) n=18 Participants 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 included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians
Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks Time 1, screening	5.08 units on a scale Standard Deviation 1.33	4.96 units on a scale Standard Deviation 1.27
Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks Time 1, intervention	4.94 units on a scale Standard Deviation 1.03	4.53 units on a scale Standard Deviation 1.41
Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks Time 2, screening	5.44 units on a scale Standard Deviation 1.00	5.06 units on a scale Standard Deviation 1.04
Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks Time 2, intervention	5.00 units on a scale Standard Deviation 1.16	5.22 units on a scale Standard Deviation 1.22
Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks Time 3, screening	5.46 units on a scale Standard Deviation .96	5.26 units on a scale Standard Deviation 1.11
Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks Time 3, intervention	5.53 units on a scale Standard Deviation 1.11	5.07 units on a scale Standard Deviation 1.17
Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks Time 4, screening	5.75 units on a scale Standard Deviation .91	5.56 units on a scale Standard Deviation 1.01
Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks Time 4, intervention	5.67 units on a scale Standard Deviation .82	5.34 units on a scale Standard Deviation 1.12

SECONDARY outcome

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

Population: This measure was completed across 3 timepoints. 2 participants dropped out of the study after post-intervention measures. 2 additional participants dropped out after two week follow up measures

Use of clinician routine suicide screening in all patient encounters was indexed via chart-stimulated recall (CSR). CSR is an established technique for examining clinician decision-making and clinical processes beyond what can be determined from chart review or self-report alone. A research team member reviewed the clinician's deidentified caseload with them for the past clinic week. For each patient seen that week, the researcher asked brief questions related to the clinicians' suicide-related practices around screening for suicide risk. Results below report the proportion of patients clinicians screened for suicide out of the total number of patients seen on one clinical day.

Outcome measures

Outcome measures
Measure	Exposure Based Implementation Strategy (EBIS) n=18 Participants 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. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.	Implementation as Usual (IAU) n=18 Participants 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 included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians
Screening Use at 3 Timepoints Across 12 Weeks Time 1	.50 units Standard Deviation .44	.56 units Standard Deviation .44
Screening Use at 3 Timepoints Across 12 Weeks Time 3	.49 units Standard Deviation .46	.52 units Standard Deviation .35
Screening Use at 3 Timepoints Across 12 Weeks Time 4	.62 units Standard Deviation .38	.54 units Standard Deviation .40

SECONDARY outcome

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

Population: This measure was completed across 2 timepoints. 2 participants dropped out after two week follow up measures

SPI Fidelity was indexed at Time 3 and Time 4 through case vignettes and standardized role play methodology. Participants received a vignette and prepare for a 45-60-minute role play, during which they were asked to complete an SPI with a patient who was determined to be at-risk for suicide following Columbia Suicide Severity Rating Scale (CSSRS) administration. Role plays were audio-recorded and coded for competence with the Safety Planning Intervention Rating Scale (SPIRS), developed by INSPIRE MPI G. Brown. This observational scale include 6 items on general safety plan intervention skills and 6 items which mapped onto the safety plan steps on a 4-point scale (0=not present to 3=excellent). Total scores were calculated by summing the 12 items with higher scores indicating greater SPI fidelity.

Outcome measures

Outcome measures
Measure	Exposure Based Implementation Strategy (EBIS) n=17 Participants 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. EBIS occurred in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention. Clinicians assigned to the EBIS arm received all elements of the EBIS plus all elements of IAU. Exposure Based Implementation Strategy (EBIS): EBIS included psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.	Implementation as Usual (IAU) n=17 Participants 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 included provision of materials. Didactic training occurred in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one consisted of materials we previously developed based on community clinician feedback. Part two followed established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also included supports for electronic health record integration (e.g., previously developed templates). After training, clinicians received 6 hours of expert consultation in small groups over 12 weeks to discuss implementation barriers and receive more role play practice. Implementation as Usual (IAU): IAU consisted of standard didactic training and ongoing consultation activities for enrolled clinicians
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: total SPIRS score	14.06 score on a scale Standard Deviation 6.71	11.88 score on a scale Standard Deviation 3.28
Safety Planning Intervention Use (Fidelity) at Time 3 (Two Weeks After Completing the Training) and Time 4 (12 Weeks After Completing the Training) Time 4: total SPIRS score	15.69 score on a scale Standard Deviation 6.65	15.38 score on a scale Standard Deviation 4.75

Adverse Events

Exposure Based Implementation Strategy (EBIS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Implementation as Usual (IAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emily Becker-Haimes

University of Pennsylvania

Phone: 215-573-5614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place