AzTrials
AzTrials

SuicideNCT05021224

Engaging Suicidal Patients in Mental Health Treatment

A study testing Caring Contacts, Reminders and Informational Poster in people with Suicide and Depression, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators will identify characteristics of suicidal patients who do or do not attend a first mental health visit following referral using administrative data. Then, the investigators will apply established approaches to contextual inquiry to identify barriers and facilitators to mental health treatment… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Suicide, Depression, Mental Health Impairment
What is being tested?
Caring Contacts, Reminders and Informational Poster
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
7 Mar 2022to 12 Jan 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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years and older
  • Elevated suicidal ideation per item 9 of the Patient Health Questionnaire (PHQ item score ≥ 1) completed during a primary care visit
  • Able to read and understand English

Who cannot join

  • Current psychotic episode requiring emergency services and/or precluding ability to provide informed consent
  • Documented diagnosis of dementia in the past 2 years. The rationale for this criteria is that these individuals may have difficulty understanding the study information provided to them, including how to opt out of the study
  • No patients will be excluded on the basis of sex, race, or ethnicity
  • Primary care provider notes that participation is not indicated
  • Already received a study engagement strategy following a different primary care visit.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Leveraging Behavioral Economics and Implementation Science to Engage Suicidal Patients in Mental Health Treatment

The investigators will identify characteristics of suicidal patients who do or do not attend a first mental health visit following referral using administrative data. Then, the investigators will apply established approaches to contextual inquiry to identify barriers and facilitators to mental health treatment attendance for individuals at risk of suicide. Using established procedures from implementation science and behavioral economics, the investigators will then leverage the insights gleaned from Aims 1 and 2, relevant theories and frameworks, and the extant literature to develop preliminary strategies to support attendance at first mental health visit. Strategies will be developed in collaboration with a team of experts in suicide, implementation science, and behavioral economics. These preliminary strategies will then be iteratively tested and refined. The investigators also will assess putative mechanism using behavioral tasks and self-report tools.

Read the detailed description

In 2017, there were more than 800,000 deaths by suicide worldwide. Patients at high risk for suicide are less likely to die by suicide if they engage in psychotherapy. However, despite the development of evidence-based practices (EBPs) for suicide prevention, rates of suicide in the U.S. have increased by approximately 30% over the past two decades. One way to lower these rates would be to increase treatment initiation among those at risk. Suicidal individuals have difficulty engaging in mental health services, yet no studies have systematically developed and tested strategies to increase treatment initiation for suicidal patients.

Nearly two-thirds of people who die by suicide interact with a primary care clinician in the year prior to death, making primary care an optimal setting in which to identify individuals at risk for suicide and connect them to mental health care. Yet only half of those referred by primary care providers attend an initial mental health visit, even when referred to care within the same practice. Various strategies to increase attendance at first appointment, including reminder calls and texts, motivational and informational interventions, and case management, have demonstrated small to moderate effects. Even when these strategies are implemented, approximately 40% of patients do not initiate treatment, suggesting that additional work is needed.

The primary objective of this study is to develop acceptable, feasible, low-cost, and effective strategies that increase patients' treatment initiation (i.e., attendance at a first mental health visit) following identification of suicide risk in primary care. The investigators will partner with a large, diverse health system to rapidly prototype and test promising strategies to achieve this objective. Rapid prototyping involves a series of rigorous tests to optimize operations in the early-study stages. Industries outside of health care commonly use this approach to learn quickly and "de-risk" decision-making on a short timeline prior to a large roll-out. To maximize generalizability, the investigators will use rapid prototyping to develop strategies for increasing attendance in both collaborative care and outpatient specialty mental health. The strategies the investigators develop and test will be informed by behavioral economics and implementation science methods, leveraging the University of Pennsylvania's P50 ALACRITY center. In accordance with an experimental medicine approach to behavior change, the investigators will also identify and target mechanisms of action that impede treatment attendance. The specific aims are to:

Aim 1. Identify characteristics of suicidal patients who do or do not attend a first mental health visit following referral. The sample will include adults 18 years and older, including Medicare, Medicaid, and commercial insurance enrollees, who are referred for mental health services after an initial screening in primary care identified suicidal ideation. Using medical records, the investigators will compare characteristics of patients who initiate treatment to those patients who do not. When possible, the investigators will utilize insurance claims data to identify any mental health services utilization that occurred outside the health system. The investigators also will explore data from patients who report suicidal ideation in primary care and are not referred to mental health services.

Aim 2. Apply established approaches to contextual inquiry to identify barriers and facilitators to mental health treatment attendance for individuals at risk of suicide. The investigators will use direct observation and brief interviews with key stakeholders, including leaders (n = 12), primary care providers (n = 12), behavioral health providers (n = 12), mental health intake coordinators (n = 5), and patients who do (n = 12) and do not (n = 12) attend a first mental health visit following referral from primary care to understand key structural and behavioral barriers, facilitators, and mechanisms to engaging patients at risk for suicide in mental health services. The investigators also will use behavioral tasks and self-report measures to assess putative mechanisms of action in patient stakeholders.

Aim 3. Rapidly prototype and test strategies to optimize engagement. Using established procedures from implementation science and behavioral economics, the investigators will leverage the insights gleaned from Aims 1 and 2, relevant theories and frameworks (e.g., EAST, Science of Behavior Change), and the extant literature to develop preliminary strategies to support attendance at first mental health visit. Based on the literature and their previous work, the investigators anticipate that strategies that target temporal discounting (e.g., incentives) and foster perceived social support (e.g., Caring Contacts) will be needed. Strategies will be developed in collaboration with a team of experts in suicide, implementation science, and behavioral economics. The investigators will then iteratively test and refine these preliminary strategies. Throughout this process, the investigators expect to uncover additional barriers and facilitators that will allow us to further refine and optimize implementation strategies. The investigators will assess putative mechanism using behavioral tasks and self-report tools.

The primary output will be a menu of promising and feasible implementation strategies that directly address barriers to the initiation of mental health services for patients at risk of suicide. These strategies will be tested in a subsequent multisite R01. The long-term goal is to reduce deaths by suicide by increasing engagement in evidence-based mental health services for individuals at risk of suicide.

Being tested
Caring Contacts, Reminders, Informational Poster, Motivational Interviewing
Medical subject headings
Suicide, Depression, Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caring ContactsBehavioural

    Non-demanding message sent from the care team

  • RemindersBehavioural

    Appointment reminders sent electronically

  • Informational PosterBehavioural

    An informational poster linking to an infographic

  • Motivational InterviewingBehavioural

    Motivational interviewing training for intake coordinators

Study groups in NCT05021224
Study groupRoleWhat they receive
Caring ContactsActive comparatorNon-demanding message sent from the care team
Receives: Behavioral: Caring Contacts
RemindersActive comparatorAppointment reminders sent electronically
Receives: Behavioral: Reminders
Informational PosterActive comparatorAn informational poster linking to an infographic
Receives: Behavioral: Informational Poster
Motivational InterviewingActive comparatorMotivational interviewing training for intake coordinators
Receives: Behavioral: Motivational Interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of Intervention Measure (AIM)

    A reliable and valid 4-item tool to assess perceptions of the acceptability of engagement strategies. Each item is rated using a 5-point ordinal response options, ranging from 1= "completely disagree" to 5="completely agree" and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater acceptability.

    Measured: 6 months

  2. Intervention Appropriateness Measure (IAM)

    A reliable and valid 4-item tool to assess perceptions of the appropriateness of engagement strategies to the context. Each item is rated using a 5-point ordinal response options, ranging from 1= "completely disagree" to 5="completely agree" and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater appropriateness.

    Measured: 6 months

  3. Feasibility of Intervention Measure (FIM)

    A reliable and valid 4-item tool to assess perceptions of the feasibility of engagement strategies. Each item is rated using a 5-point ordinal response options, ranging from 1= "completely disagree" to 5="completely agree" and scores are averaged across the four items to yield a mean scale score. Higher scores indicate greater feasibility.

    Measured: 6 months

  4. Attendance at First Mental Health Visit

    Derived from the electronic health record, defined as patient did or did not attend first mental health visit following referral.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start7 Mar 2022
  3. Primary completion12 Jan 2024
  4. Study completion12 Jan 2024

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05021224
Sponsor's protocol ID
829538
Other IDs
5R21MH123851
Status last verified
May 2025
First submitted
26 Jul 2021
Last updated
8 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All study personnel will have Patient Oriented Research certification from the University of Pennsylvania. Interview personnel meeting with primary care providers, behavioral health providers, leaders, and patients will hold a Bachelor's, Master's or doctorate degree. The PI will oversee the additional training and ongoing review of interviewers. Interviewers must display research reliability in collecting data and will work under the close supervision of the PI.

Publications

  • Wolk CB, Duresso B, Weiss SE, Khazanov GK, Candon M, Oslin DW, Patel E, Press MJ, Buttenheim A, Anderson E, Pieri M, Jager-Hyman S. Evaluating the acceptability, feasibility, and appropriateness of treatment engagement strategies for primary care patients at risk for suicide: a pilot study. Front Psychiatry. 2026 Aug 5;17:1897475. doi: 10.3389/fpsyt.2026.1897475. eCollection 2026.

    PubMed 42621426
  • Wolk CB, Pieri M, Weiss SE, Harrison J, Khazanov GK, Candon M, Oslin DW, Press MJ, Anderson E, Famiglio E, Buttenheim A, Jager-Hyman S. Engaging primary care patients at risk for suicide in mental health treatment: user insights to inform implementation strategy design. BMC Prim Care. 2024 Oct 16;25(1):371. doi: 10.1186/s12875-024-02616-w.

    PubMed 39415093
  • Khazanov GK, Jager-Hyman S, Harrison J, Candon M, Buttenheim A, Pieri MF, Oslin DW, Wolk CB. Leveraging behavioral economics and implementation science to engage patients at risk for suicide in mental health treatment: a pilot study protocol. Pilot Feasibility Stud. 2022 Aug 13;8(1):181. doi: 10.1186/s40814-022-01131-y.

    PubMed 35964151

Questions about this trial

What is this clinical trial studying?

A study testing Caring Contacts, Reminders and Informational Poster in people with Suicide and Depression, 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 5 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 8 Jun 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 8 Jun 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?

Acceptability of Intervention Measure (AIM) (time frame: 6 months). The study lists 4 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 NCT05021224, which also lists 3 linked publications.

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 8 Jun 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in