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临床试验/NCT03943862
NCT03943862终止2 期

To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt

University of Ulm2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年5月7日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
发起方
入组人数
4
试验地点
2
主要终点
Self-stigma related to suicide attempt

研究概览

简要总结

The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.

详细描述

People who have survived a suicide attempt often face public and self-stigma, and secrecy is a common strategy to minimize the risk of being labeled. Both secrecy and disclosure have pros and cons. The decision whether, when, and to whom to disclose a previous suicide attempt is complex. Interventions can provide guidance for systematic consideration and a well informed decision. Potentially, it may not be disclosure itself, but the empowered decision for or against disclosure of a previous suicide attempt that reduces distress and leads to beneficial outcomes.

The manualized peer-led group intervention "Honest, Open, Proud" (HOP) supports people with mental illness in their decision whether to disclose mental illness. Research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. Based on HOP, "To Share Or Not To Share" (2Share) was developed to systematically guide suicide attempt survivors through their decision whether and how to disclose a previous suicide attempt.

2Share led to significant reductions in self-stigma and depressive symptoms, as well as increased self-esteem in a recent pilot randomized-controlled trial (RCT) in the US. The aim of the current study is to evaluate 2Share in a German clinical setting. Feasibility and efficacy of 2 Share will be tested in a pilot RCT.

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

  • Current inpatient, outpatient or day clinical treatment at the Bezirkskrankenhaus Günzburg, Germany
  • Age ≥ 18 years
  • At least one previous suicide attempt
  • Positive screening for disclosure distress (1 item: "In general, how distressed or worried are you in terms of secrecy or disclosure of your suicide attempt?", self-report, persons with a score ≥ 4 on a scale from 1-7 are included)
  • Written informed consent
  • Sufficient German language skills

排除标准

  • Current suicidality (1 item: "Have you had thoughts that you would be better off dead for at least several days during the last week?", self-report, persons responding with yes will be excluded and will be offered support)
  • Suicide attempt within the last four weeks
  • Dementia or organic disease (ICD-10: F0)
  • Primary substance dependence (ICD-10: F1x.2)

结局指标

主要结局

Self-stigma related to suicide attempt

时间窗: 2 weeks

Self-Stigma of Suicide Attempt Survivor Scale (SSSAS), 14-item apply subscale (Sheehan et al, 2018); each item is rated from 1-9, we will calculate a sum score accross all items (range 9-126) with higher scores indicating more self-stigma.

次要结局

  • Self-stigma related to suicide attempt(baseline, 6 weeks, 12 weeks)
  • Self-Stigma (alienation) related to suicide attempt(baseline, 6 weeks, 12 weeks)
  • General disclosure distress(baseline, 2 weeks, 6 weeks, 12 weeks)
  • Depressive symptoms(baseline, 2 weeks, 6 weeks, 12 weeks)
  • Recovery(baseline, 2 weeks, 6 weeks, 12 weeks)
  • Self-esteem(baseline, 2 weeks, 6 weeks, 12 weeks)
  • Stigma stress related to suicide attempt(baseline, 2 weeks, 6 weeks, 12 weeks)
  • Secrecy about suicide attempt(baseline, 2 weeks, 6 weeks, 12 weeks)
  • Help-seeking for suicidality(baseline, 2 weeks, 6 weeks, 12 weeks)
  • Suicidal ideation(baseline, 2 weeks, 6 weeks, 12 weeks)
  • Quality of life(baseline, 2 weeks, 6 weeks, 12 weeks)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathalie Oexle

Assistant Professor

University of Ulm

研究点 (2)

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