Implementation ScienceNCT05172609
An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety Around Suicide Prevention
A study testing Exposure Based Implementation Strategy (EBIS) and Implementation as Usual (IAU) in people with Implementation Science, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implementation Science
- What is being tested?
- Exposure Based Implementation Strategy (EBIS) and Implementation as Usual (IAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Department of Psychiatry
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety About Delivering Suicide Prevention Evidence-Based Practices
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.
Read the 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
- Being tested
- Exposure Based Implementation Strategy (EBIS), Implementation as Usual (IAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure Based Implementation Strategy (EBIS)Behavioural
EBIS will include psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.
Implementation as Usual (IAU)Behavioural
IAU will consist of standard didactic training and ongoing consultation activities for enrolled clinicians
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Implementation as Usual (IAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time 4: 12 weeks after completing training
Secondary outcomes (4)
Clinician Anxiety at 4 Timepoints Across 12 Weeks
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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)
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.
Measured: Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start29 Mar 2023
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implementation ScienceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172609
- Sponsor's protocol ID
- 356336
- Status last verified
- Jul 2025
- First submitted
- 25 Aug 2021
- Last updated
- 13 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38001478
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety About Delivering Suicide Prevention Evidence-Based Practices
- ClinicalTrials.gov ID
- NCT05172609
- Acronym / sponsor ID
- 356336
- Conditions
- Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Based Implementation Strategy (EBIS) | Experimental | Behavioral: 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. 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. |
| Implementation as Usual (IAU) | Active comparator | Behavioral: Implementation as Usual (IAU)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure Based Implementation Strategy (EBIS)EBIS will include psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice. | Behavioural | Exposure Based Implementation Strategy (EBIS) |
| Implementation as Usual (IAU)IAU will consist of standard didactic training and ongoing consultation activities for enrolled clinicians | Behavioural | Implementation as Usual (IAU) |
Primary outcome
Clinician Perception of EBIS Acceptability for Clinical Practice at Time 4, 12 Weeks After Completing Training
Time frame: 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.
Clinician Perception of EBIS Feasibility and Utility for Clinical Practice at Time 4, 12 Weeks After Completing Training
Time frame: 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.
4 secondary outcomes
Clinician Anxiety at 4 Timepoints Across 12 Weeks
Time frame: 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 frame: 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 frame: 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 frame: Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38001478Becker-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Based Implementation Strategy (EBIS) and Implementation as Usual (IAU) in people with Implementation Science, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Perception of EBIS Acceptability for Clinical Practice at Time 4, 12 Weeks After Completing Training (time frame: Time 4: 12 weeks after completing training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.