Intensive Case Management Between VA and Community Care for Suicide Prevention

NCT07534358 | Recruiting DMC

• 1 other identifier: 20-1995
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to build the evidence base for SUPERCEDE, a suicide prevention focused intensive case management intervention to increase access, improve care coordination, provide suicide prevention monitoring, and procure a timely response of VA mental health and suicide prevention services among VA-enrolled veterans receiving VA authorized community care. This phase is a hybrid effectiveness Type 1 randomized control trial, which will include 2 arms: the treatment intervention, SUPERCEDE, and the control intervention, present centered therapy. The main questions it aims to answer are:• This RCT will continue to build the evidence base for effectiveness and determine feasibility and acceptability for the previously piloted SUPERCEDE. • This RCT will improve the understanding of implementation of this intervention, both in VA and VA authorized community care organizations in preparation for broader implementation. Researchers will compare SUPERCEDE and present centered therapy to see if SUPERCEDE results in improved functioning and a decrease in suicidal ideation. Participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan (CRP), intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. Detailed Description For hypothesis 3a: Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and PCT. Recruitment. Eligible participants will be identified through the VA Rocky Mountain Regional (RMR) Medical Center the VA Corporate Data Warehouse (CDW), flyers and advertisements, or through clinician or community referral. A recruitment letter will be sent to participants identified in the CDW. Investigators will attempt to contact potential participants with a warm call by telephone (up to 3 times) after the letter is sent.

Conditions

Suicidal Ideation; Mental Health Issue; Social Determinants of Health

Keywords

suicide prevention; Veteran

Outcome Measures

Primary Outcomes (3)

• Functioning: Brief Inventory of Psychosocial Functioning (B-IPF)

  B-IPF is a 7-item measure of interpersonal functioning. Scores range from 0 (not at all) to 6 (very much), with higher scores indicating worse functioning. Investigators will fit linear mixed models for the outcome variable of functioning with the between-subject factor of treatment (SUPERCEDE vs. PCT), the within- subject factor of time, and the interaction between two factors (treatment X time). Several correlation structures will be considered for repeated measures within individuals, and the best fitting structure based on Akaike Information Criterion (AIC) will be selected. Significant treatment by time interaction, with significant differences at follow-up on the B-IPF, will be considered supportive of our hypothesis.

  Baseline (Time 1), 5 weeks, 9 weeks (post-treatment), 6-month follow-up

• Suicidal Ideation: Brief Beck Scale for Suicidal Ideation (BSSI)

  The BSSI is a 21-item self report measure assessing suicidal ideation and behaviors. Scores range from 0 (no suicidal risk ideation/behaviors) to 2 (suicidal ideation/behaviors). Greater scores indicate greater suicidal ideation and behaviors. Responses will be dichotomized. The dichotomous variable (e.g., no suicidal ideation vs. suicidal ideation), and the continuous variable of suicidal ideation, when endorsed. To analyze the dichotomous outcome, a logistic regression for zero vs. nonzero values will be conducted. For the continuous variable, a zero-inflated negative binomial regression will be performed.

  Baseline (Time 1), 5 weeks (Time 2), 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)

• Formative evaluation of SUPERCEDE

  A formative evaluation will be conducted to understand optimal conditions of implementing the intervention both within the VA and in VA community care agencies. Qualitative interviews will be conducted with stakeholders (n = 20) in VA and VA community care agencies. The formative evaluation will be focused on the following: 1) understand how the intervention could further be developed for both VA and community context; 2) improve understanding of the recipients (e.g., social workers, psychologists, etc.) and their needs; 3) gain perspectives from stakeholders regarding the innovation itself to improve implementation; 4) identify facilitators and barriers to wide-spread implementation.

  9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)

Study Arms (2)

SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)

EXPERIMENTAL

SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA community care coordination.

Behavioral: SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)

Present centered therapy (PCT)

ACTIVE COMPARATOR

PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions with a safety plan if needed.

Behavioral: Present centered therapy

Interventions

SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) BEHAVIORAL

Intensive Case Management

SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)

Present centered therapy BEHAVIORAL

Control group receiving present centered therapy.

Present centered therapy (PCT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolled in the VA Eastern Colorado Health Care System (ECHCS)
• able to complete an online questionnaire
• age 18-80 years
• able to comprehend and provide virtual informed consent
• receiving both VA care and VA authorized community care, through the MISSION Act, which is related to any physical or mental health disorder
• Veteran's non-VA care is authorized (i.e., non-VA care/treatment approved in advance by the VA)
• at risk for suicide, which is defined as any 1 of the following circumstances: a) prior lifetime suicide attempt; b) suicidal ideation in the past month; c) current mental health symptoms, defined as PHQ-9 \>10, or PCL-5 \>31
• psychosocial challenges reported on the ACORN or Assessment of Needs measure
• issues with VA community care coordination (i.e., Veteran reported challenges, consults canceled in medical record, appointments canceled or rescheduled in medical record, etc.)
• receiving no or infrequent mental health services at the VA (e.g., seen less than once a month by a mental health provider).

You may not qualify if:

• not at imminent risk of suicide or homicide warranting crisis intervention (will be able to participate once stabilized)
• unable or unwilling to participate in the intervention (e.g., unwilling to provide VA community care information, etc.)
• without access to a device capable of telephone calls or video calls
• presenting with any situation which the principal investigator deems this type of care is inappropriate for the Veteran.

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Eastern Colorado Healthcare System

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (3)

• Cully, J.A., Dawson, D.B., Hamer, J., & Tharp, A.L. (2020). A provider's guide to Brief Cognitive Behavioral Therapy. Department of Veterans Affairs South Central MIRECC, Houston, TX.

  BACKGROUND

• Bryan CJ, Mintz J, Clemans TA, Burch TS, Leeson B, Williams S, Rudd MD. Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. Psychiatr Serv. 2018 Jan 1;69(1):108-111. doi: 10.1176/appi.ps.201700157. Epub 2017 Oct 2.

  PMID: 28967323 BACKGROUND

• Frost ND, Laska KM, Wampold BE. The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. J Trauma Stress. 2014 Feb;27(1):1-8. doi: 10.1002/jts.21881.

  PMID: 24515534 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Bryann B DeBeer, PhD

  Eastern Colorado Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryann B DeBeer, PhD

CONTACT

254-987-0341; Bryann.DeBeer@va.gov

Patricia D Russell, PhD

CONTACT

720-723-6557; Patricia.Russell@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be accessible only to the designated staff member who will perform the assignments, who is not involved in the protocol. Outcomes will be assessed by an assessor blind to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and present centered therapy.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: April 16, 2026
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)