跳至主要内容
临床试验/NCT05537376
NCT05537376招募中不适用

A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2023年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
69
试验地点
2
主要终点
Acceptability of SUPPORT as measured by the Client Satisfaction Questionniare-8 (CSQ-8)

研究概览

简要总结

Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.

详细描述

This 5-year study aims to refine and pilot a peer-delivered intervention to improve functional and social recovery to decrease suicide risk; the study consists of two phases. Phase 1 employs a user-centered design approach to refine SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT) aided by scientific and consumer advisory board stakeholders as well as training Peer Specialists to fidelity on pilot cases in an open trial. SUPPORT is a flexibly delivered intervention intended to augment safety planning by addressing functional and social goals personalized to each Veteran's recovery following a suicidal crisis while including cognitive learning strategies to enhance recall and salience of intervention material. Following adaptations from Phase 1, Phase 2 includes a pilot randomized controlled trial of SUPPORT compared to an enhanced standard care condition. Veteran participants in both phases will be quantitatively assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment (and qualitatively interviewed at post-treatment). Peer Specialists delivering the intervention will also be qualitatively interviewed post-treatment. The primary outcomes to be evaluated is improvement in personal recovery and reduction in suicidal ideation severity. Secondary outcomes concern changes in various domains of personal and social functioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veteran Inclusion Criteria:
  • Veterans who report present suicidal ideation (i.e., Columbia-Suicide Severity Rating Scale (C-SSRS) > 2 ("Active thoughts of killing oneself") in past 1 month and/or a suicide attempt in the prior 3 months as identified by the C-SSRS
  • Current SMI diagnosis (i.e., schizophrenia and other psychotic disorders, mood disorders with psychotic features, bipolar disorders)
  • Capable of informed consent via the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
  • Peer Specialist Inclusion Criteria:
  • Certified Peer Specialist employed at VA San Diego Healthcare System (VASDHS) in the Mental Health Care Line (individuals must demonstrate competency in basic suicide screening and referral procedures to be certified)
  • 2-3 years of experience post certification as a Certified Peer Specialist
  • Interest in being trained in SUPPORT
  • Provide verbal or written consent for the research staff to discuss ability to participate in the study with the Peer Specialist's direct clinical supervisor
  • Direct clinical supervisor agreement to allow the Peer Specialist to participate. This includes the Peer Specialist's direct clinical supervisor agreement to allow the Peer Specialist time as part of their current scope of practice to 1) participate in the full day (8-hour) SUPPORT training, 2) participate in weekly 1-hour group supervision for the duration of the Peer Specialist's time in the study, and 3) take on a case load of at least one SUPPORT Veteran at a given time.

排除标准

  • Veteran Exclusion Criteria:
  • Cannot complete the assessment battery
  • Current intoxication requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services
  • Imminent psychiatric hospitalization

研究组 & 干预措施

ESC

No Intervention

The enhanced standard care (ESC) condition contains the elements of standard practice suicide prevention delivered at VHA, which include: 1) suicide risk assessment, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, and 4) Suicide Prevention Coordinator follow-up contacts. It is enhanced due to the contact with the research study.

SUPPORT

Experimental

Veterans receiving SUPPORT will be offered all modules of the intervention via weekly, 50-minute sessions with a Peer Specialist. Following the completion of a mental health evaluation by a licensed professional, the Peer Specialist leads the Veteran who is at risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance recall of the Veteran's safety plan and improve recovery.

干预措施: SUicide Prevention by Peers Offering Recovery Tactics (Behavioral)

结局指标

主要结局

Acceptability of SUPPORT as measured by the Client Satisfaction Questionniare-8 (CSQ-8)

时间窗: At the end of the intervention, an average of 4-weeks

The CSQ-8 brief survey has been used extensively in VA and non-VA settings to assess overall satisfaction with care, and it has excellent internal consistency (0.93). An overall score" is calculated by summing the participant's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.

Feasibility of recruitment and retention

时间窗: Through study completion, an average of 4 years

Recruitment and retention is determined by the number of participants who were initially contacted, consented, completed baseline data, and completed follow-up data.

Acceptability of SUPPORT as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)

时间窗: At the end of the intervention, an average of 4-weeks

The CSQ-8 brief survey has been used extensively in VA and non-VA settings to assess overall satisfaction with care, and it has excellent internal consistency (0.93). An overall score" is calculated by summing the participant's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.

次要结局

  • Change in Recovery Assessment Scale-41(Baseline, 2-weeks, 4-weeks, 3-month follow-up)
  • Change in the Scale for Suicide Ideation (SSI)(Baseline, 2-weeks, 4-weeks, 3-month follow-up)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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