Intensive Case Management Between VA and Community Care for Suicide Prevention

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)
  Intensive Case Management
• Поведенческое Present centered therapy
  Control group receiving present centered therapy.

Первичные конечные точки

• Functioning: Brief Inventory of Psychosocial Functioning (B-IPF) [Срок оценки: Baseline (Time 1), 5 weeks, 9 weeks (post-treatment), 6-month follow-up]
• Suicidal Ideation: Brief Beck Scale for Suicidal Ideation (BSSI) [Срок оценки: Baseline (Time 1), 5 weeks (Time 2), 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)]
• Formative evaluation of SUPERCEDE [Срок оценки: 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Eastern Colorado Healthcare System — Aurora

Публикации

• 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.
• 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
• 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

Идентификаторы

NCT: NCT07534358 · 20-1995

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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