跳至主要内容
临床试验/NCT07453758
NCT07453758Enrolling By Invitation不适用

Nurse and Peer Led Suicide Prevention in Tajikistan

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
96
试验地点
1
主要终点
Columbia Suicide Severity Rating Scale

研究概览

简要总结

The study takes place in Tajikistan, a postwar country in Central Asia, where Dr. Weine, Dr. Pirova, Dr. Bahromov, and other collaborators successfully implemented a D43 research capacity building project and an R21 and R01 on stepped care for women's mental health in primary care. This study also builds on the team's prior research that demonstrated the effectiveness of nurse- and peer-led interventions, identified risk and protective factors for suicide among women, and on the PREVAIL peer-led suicide prevention model. The specific aims for this new project are: Aim 1: Adapt the evidence-based PREVAIL model into a new SUSTAIN nurse- and peer-led suicide prevention model in primary care for women at moderate or high suicide risk in rural and urban Tajikistan using a participatory co-design process (the Transcreation Framework) with multi-level partners. Aim 2: Evaluate a pilot implementation of the SUSTAIN model in primary care among 96 women with moderate to high suicide risk, 48 randomized to SUSTAIN and 48 to an enhanced usual care condition, with both groups followed for 9 months for suicidal ideations or behaviors, mental health outcomes, and mediators. Aim 3: Assess the acceptability, feasibility, appropriateness, potential for scalability and sustainability, programmatic costs, and partnership of SUSTAIN to inform a future hybrid type 2 effectiveness-implementation pragmatic trial.

研究设计

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

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Tajik women age 18 to 59 who meet operationally defined criteria for moderate or high risk suicide risk. We will identify women at-risk for suicide defined as:
  • a recent suicide attempt (past 3 months)
  • recent suicidal ideation that is accompanied by either a plan or intention as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). If they score a level 2 or higher on the C-SSRS, they are eligible. Level 2 refers to non-specific active suicidal thoughts. At level 2, a person has general, active thoughts of wanting to end their life but has not formulated a specific plan, method, or intention to act on them.
  • Other inclusion criteria are: 1) willing to participate in the SUSTAIN intervention and research procedures; and 2) able to give written informed consent.

排除标准

  • If they score less than a level 2 on the C-SSRS they are not eligible

研究组 & 干预措施

SUSTAIN intervention

Experimental

Women in the 6 intervention clinics will be enrolled in the SUSTAIN intervention. This includes nurse and peer co-lead individual, group and family sessions. There are 9 sessions that are attended by the women (6 individual and 3 group) and 1 session that is attended by their family members; this will occur over the course of 8-12 weeks depending on timing and scheduling.

The SUSTAIN Model consists of:

  • Six individual sessions for women at-risk of suicide (once a week for 1-1.5 hours)
  • Three group sessions for women at-risk of suicide (once a week for 2 hours)
  • One education group session for families of women at-risk of suicide (note, the women do not attend this session)

干预措施: Suicide prevention treatment (Behavioral)

Enhanced Care as Usual

Other

In the 6 clinics assigned to the control condition, the women who screen positive for moderate to high suicide risk will receive enhanced usual care. They will be evaluated by a family medicine doctor who will confirm their level of risk and decide on appropriate actions. This could include an admission to inpatient psychiatry, a referral to outpatient psychiatry, or management in the family medicine clinic which may include counseling, psychiatric medication, a family meeting, or a home visit. At the very least, the family medicine doctor will provide them with a list of local crisis support resources.

干预措施: Care as usual (Behavioral)

结局指标

主要结局

Columbia Suicide Severity Rating Scale

时间窗: Baseline and 3, 6, 9 months post intervention

Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) Any suicide attempt as measured according to an electronic self-report version of the Columbia Suicide Severity Rating Scale (CSSR-S). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S.

次要结局

  • Medically serious suicide attempts(3, 6, and 9 months post intervention)
  • Suicide Cognitions Scale-Short Form (SCS-S)(3, 6, and 9 month post intervention)
  • Beck Hopelessness Scale (BHS)(3, 6, 9 months post intervention)
  • Abuse Assessment Screen(3, 6, 9 month post intervention)
  • Brief Reasons for Living (BRFL)(3, 6, 9 month post intervention)
  • Patient Health Questionnaire-9 (PHQ-9)(3, 6, 9 month post intervention)
  • Generalized Anxiety Disorder-7 (GAD-7)(3, 6, 9 months post intervention)
  • PTSD CheckList - Civilian Version (PCL-C)(3, 6, 9 months post intervention)
  • Pearlin Mastery Scale(3, 6, 9 months post intervention)
  • Mental Health Knowledge Schedule (MAKS)(3, 6, 9 months post intervention)
  • Short Form Health Survey (SF-12)(3, 6, 9 months post intervention)
  • Interpersonal Needs Questionnaire (INQ)(3, 6, 9 months post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验