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The Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility Study

The Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03376113
Enrollment
68
Registered
2017-12-18
Start date
2017-11-03
Completion date
2019-10-31
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide and Self-harm

Keywords

self-harm, psychological intervention

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALthe volitional help sheet

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.

Sponsors

Academia Sinica, Taiwan
CollaboratorOTHER
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

In phase I Inclusion Criteria: 1. With self-harm experience in the past month 2. Aged 20 years or over

Exclusion criteria

1. With severe hallucinations or delusions or medically unfit for interview 2. Limited hands movement (e.g. seriously wounded wrists) In phase II Inclusion Criteria: 1. Admitted to the ER following an episode of self-harm 2. Aged 20 years or over

Design outcomes

Primary

MeasureTime frameDescription
Time to next self-harm repetition (in days) following randomization6 monthsTime to next self-harm repetition (in days) following randomization according to hospital records and a nationwide self-harm registry.
The acceptability of the intervention to patientswithin 6 months of study completionThe 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 settingwithin 6 months of study completionThe investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention delivery at the ER setting.
Patient recruitmentBaselineRecruitment: 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.3 monthsThe 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.6 monthsThe 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.3 monthsThe 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.6 monthsThe 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.6 monthsThe 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.3 monthsThe 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 monthsBaseline, 3 monthsAs 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 monthsBaseline, 6 monthsAs 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 records3 monthsNumber 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 registry3 monthsNumber 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 records6 monthsNumber 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 registry6 monthsNumber of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry

Secondary

MeasureTime frameDescription
Times of use of the volitional help sheet6 monthsTimes of use of the volitional help sheet based on the number of visits to the individualized website of the volitional help sheet.

Countries

Taiwan

Contacts

Primary ContactShu-Sen Chang, MD, MSc, PhD
shusenchang@ntu.edu.tw+886 2 33668062

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026