THRIVE: Hybrid Randomized Effectiveness-Implementation Trial of a Recovery-Focused Suicide Prevention Intervention for Crisis Stabilization Centers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 552
- 试验地点
- 3
- 主要终点
- Total Suicide Risk Events (SREs) per Arm
研究概览
简要总结
Suicide is a major public health concern in the United States, with more than 1.4 million adults attempting suicide and nearly 50,000 adults dying by suicide each year. The launch of the national 3-digit 988 Suicide & Crisis Lifeline in 2022 has strengthened the crisis care system by emphasizing the need for people in crisis to have someone to call, someone to respond, and somewhere to go. Community-based Crisis Stabilization Centers (CSCs) are an important part of the crisis care system, providing short-term crisis stabilization services and an alternative to Emergency Department care. However, suicide risk can remain high after discharge from CSCs, and no brief, effective, recovery-focused interventions are currently available for this setting.
This study will evaluate the effectiveness of THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement) in CSCs. THRIVE is a recovery-focused intervention designed for adults receiving care for suicide risk . THRIVE includes one 60-minute psychotherapy group (focused on belonging, giving, meaningful living, and recovery) delivered during the CSC stay and up to six peer-led recovery coaching calls during the weeks following discharge.
This multi-site Hybrid Type 1 randomized effectiveness-implementation trial will enroll 552 participants and compare care as usual (CAU) in CSCs to CAU plus THRIVE (CAU + THRIVE). The primary purpose of this study is to determine whether THRIVE reduces suicide risk events (SREs) following CSC discharge, including crisis care re-admissions, escalation to higher levels of care, suicide attempts, and suicide deaths. The study will also examine barriers and facilitators that may influence the adoption and implementation of THRIVE in community-based crisis settings.
详细描述
The study is designed to determine whether Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement (THRIVE), a brief, recovery-focused group psychotherapy intervention initiated during a Crisis Stabilization Center (CSC) stay and continued by peer-support specialists during the six-week transition back to the community can reduce post-discharge suicide risk events (SREs) while improving treatment engagement and recovery. Findings will also provide information about the ways THRIVE may work and the factors that may support or hinder its implementation in community-based crisis care settings.
Effectiveness. The primary aim of this study is to determine whether THRIVE reduces SREs during the 12 months following CSC discharge. A total of 552 CSC participants will be randomized to receive either Care as Usual (CAU) or CAU plus THRIVE. CAU includes routine CSC services, including medication management, safety planning, referral to outpatient treatment, and a post-discharge follow-up contact. Participants assigned to CAU plus THRIVE will receive these services in addition to the THRIVE psychotherapy group and six post-discharge peer recovery coaching calls. Participants will complete assessments at baseline and discharge, weekly during the first 6 weeks after discharge, and at 3, 6, and 12 months. The primary outcome is SREs post discharge, the total aggregated occurrences of crisis care events including re-admissions, escalation to higher levels of care, suicide attempts, and suicide deaths.
Mechanisms. A secondary aim is to examine the psychological and behavioral processes through which THRIVE may reduce SREs post-discharge. Consistent with the Interpersonal Theory of Suicide, the study will examine whether THRIVE improves perceived burdensomeness and thwarted belongingness, and whether it increases treatment initiation and engagement following CSC discharge. Our study will evaluate whether changes in these factors help explain the relationship between THRIVE participation and subsequent suicide risk events.
Implementation. The study will also evaluate barriers and facilitators to implementing THRIVE in routine CSC practice. A mixed-methods implementation evaluation guided by the Consolidated Framework for Implementation Research (CFIR) will examine factors associated with intervention adoption and delivery across the three participating CSCs.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to CSC with suicidal crisis, as defined by active suicide ideation ascertained by the Columbia Suicide-Severity Rating scale (C-SSRS), which the sites already routinely administer
- •Ability and willingness to provide information and permission to contact at least one person in case of emergency or inability to reach the participant for follow-up.
排除标准
- •Inability to communicate with the researcher in English.
- •Acute psychiatric instability (e.g., psychotic symptoms) prohibiting participation in psychotherapy.
研究组 & 干预措施
Care as Usual
Care as Usual in the Crisis Stabilization Centers includes medication management, the safety planning Intervention, individual counseling, group psychoeducation, discharge planning, and community referral linkages.
干预措施: Center Care as Usual (Behavioral)
Care as Usual + THRIVE
Behavioral: THRIVE Toward Hope, Recovery, Interpersonal Growth, Values and Engagement (THRIVE), is a brief, suicide-specific, narrative, recovery-focused, 60 minute group psychotherapy intervention followed by up to 6 peer-led recovery coaching phone calls. THRIVE includes five components: 1) Creating a Safe Space for Disclosure; 2) Psychoeducation on Suicide Recovery; 3) Sharing the Suicide Narrative; 4) Completing the Meaningful Living Plan; 5) Taking Action on the Meaningful Living Plan in the Community.
Behavioral: Usual Care Care as Usual in Crisis Stabilization Centers includes medication management, the safety planning Intervention, group psychoeducation, individual counseling, discharge planning, and community referral linkages
干预措施: Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement (THRIVE) (Behavioral)
Care as Usual + THRIVE
Behavioral: THRIVE Toward Hope, Recovery, Interpersonal Growth, Values and Engagement (THRIVE), is a brief, suicide-specific, narrative, recovery-focused, 60 minute group psychotherapy intervention followed by up to 6 peer-led recovery coaching phone calls. THRIVE includes five components: 1) Creating a Safe Space for Disclosure; 2) Psychoeducation on Suicide Recovery; 3) Sharing the Suicide Narrative; 4) Completing the Meaningful Living Plan; 5) Taking Action on the Meaningful Living Plan in the Community.
Behavioral: Usual Care Care as Usual in Crisis Stabilization Centers includes medication management, the safety planning Intervention, group psychoeducation, individual counseling, discharge planning, and community referral linkages
干预措施: Center Care as Usual (Behavioral)
结局指标
主要结局
Total Suicide Risk Events (SREs) per Arm
时间窗: 12 Months
The primary outcome, total Suicide Risk Events (SREs), is a participant's aggregate number of crisis care contacts and events for suicide risk (e.g., crisis re-admissions, escalations, suicidal behaviors including suicide attempts, suicide deaths) in the 12-months post-discharge. The investigative team will discover post-discharge events via: 1) Participant follow-up surveys, including the Columbia Suicide Severity Rating Scale; 2) Electronic Health Record data; 3) Claims data. Blinded, trained, reviewers will apply a pre-set codebook with adjudication rules to determine whether post-discharge events are suicide-related or non-suicide related. Afterward, the unduplicated SREs from all sources up to 12 months post-discharge will be summed to calculate the total SREs for a participant, a count outcome measure.
次要结局
未报告次要终点
研究者
Jennifer Lockman
Principal Investigator
University of Alabama at Birmingham