- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534358
Intensive Case Management Between VA and Community Care for Suicide Prevention (SUPERCEDERCT)
Improving Access to VA Mental Health and Suicide Prevention Services: A Randomized Clinical Trial of Intensive Case Management Between VA and Community Care (SUPERCEDE RCT)
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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bryann B DeBeer, PhD
- Phone Number: 254-987-0341
- Email: Bryann.DeBeer@va.gov
Study Contact Backup
- Name: Patricia D Russell, PhD
- Phone Number: 720-723-6557
- Email: Patricia.Russell@va.gov
Study Locations
-
-
Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Eastern Colorado Healthcare System
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Contact:
- Bryann DeBeer, PhD
- Phone Number: 254-987-0341
- Email: Bryann.DeBeer@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Veterans must be:
- 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).
Exclusion Criteria: Veterans must be:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)
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.
|
Intensive Case Management
|
|
Active Comparator: Present centered therapy (PCT)
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.
|
Control group receiving present centered therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functioning: Brief Inventory of Psychosocial Functioning (B-IPF)
Time Frame: Baseline (Time 1), 5 weeks, 9 weeks (post-treatment), 6-month follow-up
|
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)
Time Frame: Baseline (Time 1), 5 weeks (Time 2), 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
|
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.
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Baseline (Time 1), 5 weeks (Time 2), 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
|
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Formative evaluation of SUPERCEDE
Time Frame: 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
|
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)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bryann B DeBeer, PhD, Eastern Colorado Healthcare System
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-1995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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