跳至主要内容
临床试验/NCT05018897
NCT05018897Unknown不适用

Randomized Controlled Trial of a Strategic Disclosure Intervention for Suicide Attempt Survivors

Illinois Institute of Technology2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Change from Baseline in suicidality on the 9-item Suicidal Ideation Attributes Scale (SIDAS) at Week 6 and Week 19

研究概览

简要总结

While suicide prevention depends on people disclosing suicidal thoughts and behaviors in order to get help, those who talk about their suicidality also face negative responses from the people who they tell. The investigators will conduct a randomized controlled trial of a peer-led strategic disclosure intervention for suicide attempt survivors (The To Share or Not to Share Program; called 2Share). This study evaluates the impact of the intervention on suicidal thoughts and behaviors, depression, stigma, disclosure behaviors, and psychosocial outcomes.

详细描述

The estimated 1.3 million Americans who survive a suicide attempt suicide each year are at risk for ongoing suicide ideation, repeated suicide attempts, and ultimately dying by suicide. While suicide prevention often depends on people openly discussing suicidal thoughts and behaviors in order to get help for themselves or others, those who talk about their suicidality often face negative reactions from confidants. Stigmatizing responses in the form of stereotypes, prejudice, and discrimination may exacerbate symptoms and interfere with social relationships, employment opportunities, and help seeking. Feelings of shame and rejection are common experiences of suicide attempt survivors and the mere anticipation of rejection can encourage attempt survivors to maintain their silence.

Research suggests that suicide disclosure could help suicide attempt survivors in attaining needed care, expanding social support networks, strengthening relationships, and advancing coping strategies. However, few interventions are available to assist suicide attempt survivors in making critical disclosure decisions.

A peer-led strategic disclosure intervention (The 2Share Program), developed through a collaborative process with suicide attempt survivors, aids participants in: (a) evaluating the benefits and risks of disclosure; (b) considering ways to disclose; and (c) developing disclosure scripts. A pilot randomized controlled trial (RCT) with community-dwelling attempt survivors (n=38) found that intervention participants had significantly decreased depression and internalized stigma, and increased self-esteem as compared with the control group. However, this study was small and did not evaluate changes in suicidal thoughts and behaviors, help-seeking, or disclosure outcomes. The methodology was also limited in measuring longer term outcomes.

Given limitations of past research, the investigators propose a randomized controlled trial of the 2Share strategic disclosure program for community-dwelling suicide attempt survivors. The primary goal of this study is to evaluate the impact of the intervention on suicidal thoughts and behaviors and depression. Secondary goals are to examine intervention impact on stigma, disclosure, and psychosocial outcomes. A final goal of the project is to qualitatively examine participant experiences with disclosure over time.

The proposed research addresses the American Foundation for Suicide Prevention priority of determining what interventions are effective and what prevents individuals from engaging in suicidal behavior. The 2Share intervention is the first to address strategic disclosure in suicide attempt survivors, and this study will provide important data about disclosure that can ultimately aid in understanding suicide prevention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • 18 years or older
  • self-reported diagnosis of mood disorder
  • At least one lifetime suicide attempt

排除标准

  • a self-reported suicide attempt within the last 3 months
  • do have concerns about disclosure/ not willing to participate in program
  • do not have email address
  • do not have technical capability to connect to virtual platform
  • cannot speak or read English

结局指标

主要结局

Change from Baseline in suicidality on the 9-item Suicidal Ideation Attributes Scale (SIDAS) at Week 6 and Week 19

时间窗: Baseline, Week 6, Week 19

The SIDAS is a validated, self-reported instrument assessing suicidality over the past month. Possible item scores range from 0 (no thoughts) to 10 (always) Change = (Week 6 Score - Baseline Score), (Week 19 - Baseline Score)

Change from Baseline in depression on the 10- item Center for Epidemiologic Studies Depression Scale (CESD-10) at Week 6 and Week 19

时间窗: Baseline, Week 6, Week 19

he CESD-10 is a validated, self-reported instrument assessing depression over the past week. Possible item scores range from 1 (rarely to none of the time) to 4 (most or all of the time)

次要结局

  • Change from Baseline in stigma-related stress on the 8- item Suicide Stigma Stress Scale (4S) at Week 6 and Week 19(Baseline, Week 6, Week 19)
  • Change from Baseline in disclosure self-efficacy on the 2- item Disclosure Self-Efficacy (DSE) scale at Week 6 and Week 19(Baseline, Week 6, Week 19)
  • Change from Baseline in internalized stigma on the 9- item Internalized Stigma of Suicide (ISSA) at Week 6 and Week 19(Baseline, Week 6, Week 19)
  • Change from Baseline in secrecy on the 14- item Self-Harm and Suicide Disclosure Scale (SHSDS) at Week 6 and Week 19(Baseline, Week 6, Week 19)
  • Change from Baseline in quality of life on the 1- item quality of life scale at Week 6 and Week 19(Baseline, Week 6, Week 19)
  • Change from Baseline in self-esteem on the 10- item Rosenberg Self-Esteem (RSE) scale at Week 6 and Week 19(Baseline, Week 6, Week 19)
  • Change from Baseline in secrecy on the 5- item Secrecy scale at Week 6 and Week 19(Baseline, Week 6, Week 19)
  • Change from Baseline in mental health seeking on the 3- item Mental Health Seeking Intention scale (MHSIS) at Week 6 and Week 19(Baseline, Week 6, Week 19)
  • Change from Baseline in social support on the 8- item social support scale at Week 6 and Week 19(Baseline, Week 6, Week 19)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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