NCT05021224

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 8, 2025

Completed
Last Updated

June 8, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

July 26, 2021

Results QC Date

May 2, 2025

Last Update Submit

May 27, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    6 months

  • 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.

    6 months

  • 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.

    6 months

  • 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.

    6 months

Study Arms (4)

Caring Contacts

ACTIVE COMPARATOR

Non-demanding message sent from the care team

Behavioral: Caring Contacts

Reminders

ACTIVE COMPARATOR

Appointment reminders sent electronically

Behavioral: Reminders

Informational Poster

ACTIVE COMPARATOR

An informational poster linking to an infographic

Behavioral: Informational Poster

Motivational Interviewing

ACTIVE COMPARATOR

Motivational interviewing training for intake coordinators

Behavioral: Motivational Interviewing

Interventions

Caring ContactsBEHAVIORAL

Non-demanding message sent from the care team

Caring Contacts
RemindersBEHAVIORAL

Appointment reminders sent electronically

Reminders

An informational poster linking to an infographic

Informational Poster

Motivational interviewing training for intake coordinators

Motivational Interviewing

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

SuicideDepressionSuicidal Ideation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Courtney Wolk
Organization
University of Pennsylvania

Study Officials

  • Courtney Benjamin Wolk, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Shari Jager-Hyman, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 25, 2021

Study Start

March 7, 2022

Primary Completion

January 12, 2024

Study Completion

January 12, 2024

Last Updated

June 8, 2025

Results First Posted

June 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

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.

Locations