Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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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)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
United States
Colorado
Eastern Colorado Healthcare System
RECRUITING
Aurora
Contact Information
Primary
Bryann B DeBeer, PhD
Bryann.DeBeer@va.gov
254-987-0341
Backup
Patricia D Russell, PhD
Patricia.Russell@va.gov
720-723-6557
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 100
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: US Department of Veterans Affairs
Leads: VA Eastern Colorado Health Care System

This content was sourced from clinicaltrials.gov