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Clinical Trials/NCT03376113
NCT03376113
Unknown
Not Applicable

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

National Taiwan University Hospital1 site in 1 country68 target enrollmentNovember 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide and Self-harm
Sponsor
National Taiwan University Hospital
Enrollment
68
Locations
1
Primary Endpoint
The acceptability of the intervention to patients
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2017
End Date
October 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • With self-harm experience in the past month
  • 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)
  • 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)

Outcomes

Primary Outcomes

The acceptability of the intervention to patients

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

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 3-month.

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

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 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 based on hospital records

Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry

Time Frame: 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

Time Frame: 6 months

Time to next self-harm repetition (in days) following randomization according to hospital records and a nationwide self-harm registry.

Secondary Outcomes

  • Times of use of the volitional help sheet(6 months)

Study Sites (1)

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