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

Primary Purpose

Suicide and Self-harm

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
the volitional help sheet
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide and Self-harm focused on measuring self-harm, psychological intervention

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  1. With severe hallucinations or delusions or medically unfit for interview
  2. Limited hands movement (e.g. seriously wounded wrists)

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VHS group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 2, 2017
Last Updated
December 15, 2017
Sponsor
National Taiwan University Hospital
Collaborators
Academia Sinica, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03376113
Brief Title
The Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility Study
Official Title
The Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Academia Sinica, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm
Keywords
self-harm, psychological intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VHS group
Arm Type
Experimental
Arm Description
Patients will be asked to make links between critical situations and appropriate solutions in the volitional help sheet (VHS).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
the volitional help sheet
Intervention Description
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.
Primary Outcome Measure Information:
Title
The acceptability of the intervention to patients
Description
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
Title
The feasibility of intervention delivery at the ER setting
Description
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
Title
Patient recruitment
Description
Recruitment: the proportion of patients who are eligible and invited actually consent to participate.
Time Frame
Baseline
Title
The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up.
Description
The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up.
Time Frame
3 months
Title
The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up.
Description
The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up.
Time Frame
6 months
Title
The proportion of participating patients who can be traced from the hospital record at the 3-month.
Description
The proportion of participating patients who can be traced from the hospital record at the 3-month.
Time Frame
3 months
Title
The proportion of participating patients who can be traced from the hospital record at the 6-month.
Description
The proportion of participating patients who can be traced from the hospital record at the 6-month.
Time Frame
6 months
Title
The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month.
Description
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
Title
The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month.
Description
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
Title
Change in scores on a self-report suicidal behaviors assessment from baseline to 3 months
Description
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
Title
Change in scores on a self-report suicidal behaviors assessment from baseline to 6 months
Description
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
Title
Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records
Description
Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records
Time Frame
3 months
Title
Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry
Description
Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry
Time Frame
3 months
Title
Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records
Description
Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records
Time Frame
6 months
Title
Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry
Description
Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry
Time Frame
6 months
Title
Time to next self-harm repetition (in days) following randomization
Description
Time to next self-harm repetition (in days) following randomization according to hospital records and a nationwide self-harm registry.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Times of use of the volitional help sheet
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
In phase I 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Sen Chang, MD, MSc, PhD
Phone
+886 2 33668062
Email
shusenchang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Sen Chang, MD, MSc, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Sen Chang, MD, MSc, PhD
Phone
+886 2 33668062
Email
shusenchang@ntu.edu.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
Citation
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.
Results Reference
derived
PubMed Identifier
32368793
Citation
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.
Results Reference
derived

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

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