An interventional study of the volitional help sheet in Suicide and Self-harm, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-12-18.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Prevention
Among 10 studies in Suicide with a site in Taiwan — none open to participants now, none under way, none of them phase 3. Suicide · Taiwan.
Among the 10 studies in Suicide with a site in Taiwan, this one is the only one that started in 2017, is one of 6 with no phase, and was the 7th registered.
607 studies on the registry are indexed under Suicide; 162 are open to participants now.
This study's planned enrollment of 68 is below the median of 104 across 490 interventional studies indexed under Suicide.
Browse Suicide studies →None of the 10 studies in Suicide with a site in Taiwan is open now.
Of the 114 Suicide studies recruiting now, 54 (47%) set no upper age limit and 57 (50%) stop at 75 or younger; 52 take children under 18; 24 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2017.
Median enrollment 58 across the 8 interventional studies, 75 across the 2 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
1 of 10 have an industry lead sponsor. The 8 most frequent:
National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
National Taiwan University Hospital has 3 studies filed under Suicide — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Suicide with a site in Taiwan, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
In phase I
Inclusion Criteria:
Exclusion Criteria:
In phase II
Inclusion Criteria:
Exclusion Criteria:
Patients will be asked to make links between critical situations and appropriate solutions in the volitional help sheet (VHS).
Behavioral: the volitional help sheet
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.
A sheet includes two columns: one shows critical situations that easily trigger self-harm; other one shows appropriate solutions for patients to prevent self-harm.
The acceptability of the intervention to patients
The investigators will conduct face-to-face qualitative interviews to understand the acceptability of the intervention amongst patients.
Time frame: within 6 months of study completion
The feasibility of intervention delivery at the ER setting
The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention delivery at the ER setting.
Time frame: within 6 months of study completion
Patient recruitment
Recruitment: the proportion of patients who are eligible and invited actually consent to participate.
Time frame: Baseline
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 3-month follow-up.
Time frame: 3 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 reached by telephone contact at the 6-month follow-up.
Time frame: 6 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 3-month.
Time frame: 3 months
The proportion of participating patients who can be traced from the hospital record at the 6-month.
The proportion of participating patients who can be traced from the hospital record at the 6-month.
Time frame: 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 6-month.
Time frame: 6 months
The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month.
The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month.
Time frame: 3 months
Change in scores on a self-report suicidal behaviors assessment from baseline to 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.
Time frame: Baseline, 3 months
Change in scores on a self-report suicidal behaviors assessment from baseline to 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.
Time frame: Baseline, 6 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 based on hospital records
Time frame: 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 3 months after intervention recorded in the nationwide self-harm registry
Time frame: 3 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 based on hospital records
Time frame: 6 months
Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry
Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry
Time frame: 6 months
Time to next self-harm repetition (in days) following randomization
Time to next self-harm repetition (in days) following randomization according to hospital records and a nationwide self-harm registry.
Time frame: 6 months
Times of use of the volitional help sheet
Times of use of the volitional help sheet based on the number of visits to the individualized website of the volitional help sheet.
Time frame: 6 months
Started Nov 2017 (actual). Primary completion is estimated for Oct 2019, 23 months after the start.
Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 23 months is below that.
Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital →