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临床试验/NCT04420546
NCT04420546已完成不适用

Using Implementation Intentions to Reduce Self-harm

University of Manchester2 个研究点 分布在 1 个国家目标入组 1,040 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,040
试验地点
2
主要终点
Non-suicidal self-harm

研究概览

简要总结

The aim of the present research is to explore whether a brief intervention based on psychological theory can help people to avoid self-harming. The intervention is the Volitional Help Sheet (VHS), or "IF-THEN" plans, which will be tested in the context of trying to reduce self-harm.

Each participant will be randomly allocated to one of two conditions. The two conditions are: (1) a control condition, and (2) intervention (form multiple implementation intentions from a drop-down menu). The main outcome measure will be reduction in self-harm, which will be self-reported

详细描述

Background and study aims The purpose of this study is to explore whether a brief intervention based on psychological theory can help people to avoid self-harming. The intervention is the Volitional Help Sheet (VHS), or "IF-THEN" plans, which will be tested in the context of trying to reduce self-harm. An example of an "IF-THEN" plan is "If I feel the urge to self-harm when I want to get relief from a terrible state of mind, Then I will do something else instead of self-harming". IF-THEN plans work by helping people to link a critical situation ("If I am tempted to self-harm when I want to get some attention"), to an appropriate response ("Then I will do something else instead of self-harming").

Implementation intentions (i.e., making if-then plans) are effective at changing behaviour. The investigators have had previous success in using the VHS to reduce self-harm in people recently admitted to hospital for self-harm. The next stage of the research is to explore whether this intervention is acceptable and effective in the population more generally.

Research shows that if people can spot situations in which they may be tempted to self-harm and identify ways of overcoming those situations, they are much more likely to be successful in avoiding self-harming.

Who can participate? Adults aged over 18 years of age, have a history of self-harm, and have good verbal and written understanding of English What does the study involve? The research will involve two phases which aim to examine the acceptability and effectiveness of a brief psychological intervention to reduce self-harm.

Phase 1 Phase 1 involves a wide scale roll out of the VHS, to test the effectiveness of the VHS in reducing self-harm, and to gather feedback about the acceptability of the intervention. YouGov (a survey panel company) will collect the data on behalf of the research team over a period of 6 months (including a baseline and six-month follow-up), and store the data on a secure server, before sending to the research team. The research team at the University of Manchester will conduct and analyse the data. A sample of 1,000 people will take part in Phase 1 and will be randomly allocated to receive either the Volitional Help Sheet (intervention group; to make links between situations and solutions), or a control group (using the same intervention, but for a different behaviour [increasing physical activity]).

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
Double (Participant, Investigator)

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

  • Aged 18 and over
  • Have a history of self-harm
  • Good verbal and written understanding of English

排除标准

  • Aged under 18 years of age
  • No history of self-harm
  • Poor verbal and written understanding of English
  • Not currently resident of an inpatient facility for mental illness

结局指标

主要结局

Non-suicidal self-harm

时间窗: 6 months

'Have you ever deliberately harmed yourself in any way but not with the intention of killing yourself? (i.e., self-harm)' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

Suicidal ideation

时间窗: 6 months

'Have you ever seriously thought of taking your life, but not actually attempted to do so?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

suicide attempts

时间窗: 6 months

'Have you ever made an attempt to take your life, by taking an overdose of tablets or in some other way?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

次要结局

  • State self-regulation(6 months)
  • Frequencies with which critical situations were encountered and appropriate responses were used(6 months)
  • Habit(6 months)
  • Exposure to suicide and mental imagery about death(6 months)
  • Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Chris Keyworth

Research Fellow

University of Manchester

研究点 (2)

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