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

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.

Study Overview

• Status: Unknown
• Conditions: Suicide and Self-harm
• Intervention / Treatment: Behavioral: the volitional help sheet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shu-Sen Chang, MD, MSc, PhD; Phone Number: +886 2 33668062; Email: shusenchang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Shu-Sen Chang, MD, MSc, PhD; Phone Number: +886 2 33668062; Email: shusenchang@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VHS group; Patients will be asked to make links between critical situations and appropriate solutions in the volitional help sheet (VHS).	Behavioral: the 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Academia Sinica, Taiwan
• Investigators: Principal Investigator: Shu-Sen Chang, MD, MSc, PhD, National Taiwan University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: psychological intervention; self-harm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Self-Injurious Behavior
• Other Study ID Numbers: 201708008RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No