The Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- The acceptability of the intervention to patients
研究概览
简要总结
Recent research has focused on examining brief interventions for reducing self-harm, such as the volitional help sheet (VHS). The VHS is a theory-based psychological intervention. Two previous studies applying this tool for reducing self-harm repetition showed inconsistent results; one showed reduced subsequent self-reported suicidal ideation and behavior in patients presenting to hospital for self-harm, whilst the other showed no effect on the number of patients who re-presented to hospital with self-harm. The aim of this study is to investigate the feasibility of the VHS intervention amongst self-harm patients in Taiwan and explore its effect on self-harm repetition based on self-reported self-harm, hospital re-presentations with self-harm, and self-harm episodes from a nationwide self-harm registry. It is a two-phase study: first a qualitative study and second an exploratory randomized control trial. The first study is to interview people who self-harm about their perceptions about the VHS on the online platform, to inform the modification of VHS and the best way to intervene. The second is to examine the feasibility and effect of this intervention at the emergency department setting.
详细描述
Suicide is an important public health issue and leads to substantial social and economic burden. Self-harm is a significant risk factor of subsequent suicide attempt and suicide. However, previously studied interventions for reducing self-harm repetition such as long-term psychological therapies would not be feasible at acute settings such as emergency departments. It is also challenging to maintain patients who self-harm in long-term treatments. The volitional help sheet (VHS) is a brief, theory-based psychological intervention. Two recent studies applying this tool for reducing self-harm repetition showed inconsistent results; one showed reduced subsequent self-reported suicidal ideation and behavior in patients presenting to hospital for self-harm, whilst the other showed no effect on the number of patients who re-presented to hospital with self-harm. To investigate the feasibility of the VHS intervention for self-harm patients and explore its effect on self-harm repetition in Taiwan, the investigators will conduct a two-phase study: first a qualitative study and second an exploratory randomized control trial.
In phase I, the qualitative study, eight patients with recent self-harm will be recruited from the psychiatric ward and interviewed about their perceptions about the VHS and views about the best way to intervene.
In phase II, the exploratory randomized control trial, the investigators will recruit 60 patients presenting to the emergency department following an episode of self-harm. Patients will be randomly assigned (1:1) to the intervention group, which will be given the VHS intervention on an online platform, or the control group to examine the feasibility and effect of this intervention. The primary outcomes will be self-harm repetition based on: i) self-reported self-harm in a telephone based follow-up survey, ii) hospital re-presentations with self-harm based on hospital records, and iii) self-harm episodes from a nationwide self-harm registry, the National Suicide Surveillance System (NSSS). The NSSS includes a web-based reporting system and all emergency departments across the country are asked to report information about all people present to hospitals following an episode of self-harm. In addition, we will report the sub-group analyses for past self-harm hospitalisation according to the suggestion from the study testing VHS on reducing self-harm in United Kingdom.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With self-harm experience in the past month
- •Aged 20 years or over
排除标准
- •With severe hallucinations or delusions or medically unfit for interview
- •Limited hands movement (e.g. seriously wounded wrists)
- •In phase II
- •Inclusion Criteria:
- •Admitted to the ER following an episode of self-harm
- •Aged 20 years or over
- •Exclusion Criteria:
- •With severe hallucinations or delusions or medically unfit for interview
- •Limited hands movement (e.g. seriously wounded wrists)
研究组 & 干预措施
VHS group
Patients will be asked to make links between critical situations and appropriate solutions in the volitional help sheet (VHS).
干预措施: the volitional help sheet (Behavioral)
Control group
Patients will be asked to read the VHS. This is an active control group. That means all patients in this study will be exposed to situations and solutions in the VHS.
结局指标
主要结局
The acceptability of the intervention to patients
时间窗: within 6 months of study completion
The investigators will conduct face-to-face qualitative interviews to understand the acceptability of the intervention amongst patients.
The feasibility of intervention delivery at the ER setting
时间窗: within 6 months of study completion
The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention delivery at the ER setting.
Patient recruitment
时间窗: Baseline
Recruitment: the proportion of patients who are eligible and invited actually consent to participate.
The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up.
时间窗: 3 months
The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up.
The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up.
时间窗: 6 months
The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up.
The proportion of participating patients who can be traced from the hospital record at the 3-month.
时间窗: 3 months
The proportion of participating patients who can be traced from the hospital record at the 3-month.
The proportion of participating patients who can be traced from the hospital record at the 6-month.
时间窗: 6 months
The proportion of participating patients who can be traced from the hospital record at the 6-month.
The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month.
时间窗: 6 months
The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month.
The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month.
时间窗: 3 months
The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month.
Change in scores on a self-report suicidal behaviors assessment from baseline to 3 months
时间窗: Baseline, 3 months
As measured by the total score of the Suicidal Behaviors Questionnaire-Revised (SBQ-R), a 4-item scale for assessing suicidal behavior and ideation. The total score ranges from 3 to 18.
Change in scores on a self-report suicidal behaviors assessment from baseline to 6 months
时间窗: Baseline, 6 months
As measured by the total score of the Suicidal Behaviors Questionnaire-Revised (SBQ-R), a 4-item scale for assessing suicidal behavior and ideation. The total score ranges from 3 to 18.
Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records
时间窗: 3 months
Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records
Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry
时间窗: 3 months
Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry
Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records
时间窗: 6 months
Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records
Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry
时间窗: 6 months
Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry
Time to next self-harm repetition (in days) following randomization
时间窗: 6 months
Time to next self-harm repetition (in days) following randomization according to hospital records and a nationwide self-harm registry.
次要结局
- Times of use of the volitional help sheet(6 months)