NCT03376113

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 3, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

December 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

November 2, 2017

Last Update Submit

December 15, 2017

Conditions

Suicide and Self-harm

Keywords

self-harmpsychological intervention

Outcome Measures

Primary Outcomes (16)

  • 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.

    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.

    within 6 months of study completion

  • Patient recruitment

    Recruitment: the proportion of patients who are eligible and invited actually consent to participate.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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

    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.

    6 months

Secondary Outcomes (1)

  • Times of use of the volitional help sheet

    6 months

Study Arms (2)

VHS group

EXPERIMENTAL

Patients will be asked to make links between critical situations and appropriate solutions in the volitional help sheet (VHS).

Behavioral: the volitional help sheet

Control group

NO INTERVENTION

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.

Interventions

the volitional help sheetBEHAVIORAL

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.

VHS group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With self-harm experience in the past month
  • Aged 20 years or over

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

    PMID: 33884617DERIVED

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

    PMID: 32368793DERIVED

MeSH Terms

Conditions

SuicideSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Shu-Sen Chang, MD, MSc, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Sen Chang, MD, MSc, PhD

CONTACT

+886 2 33668062shusenchang@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2017

First Posted

December 18, 2017

Study Start

November 3, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

December 18, 2017

Record last verified: 2017-10

Locations

TW(1)