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

Suicide and Self-harm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376113
• Other study ID #: 201708008RINB
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2017
• Last updated: December 15, 2017
• Start date: November 3, 2017
• Est. completion date: October 2019

Study information

• Verified date: October 2017
• Source: National Taiwan University Hospital
• Contact: Shu-Sen Chang, MD, MSc, PhD
• Phone: +886 2 33668062
• Email: shusenchang[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Suicide
• Suicide and Self-harm

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Academia Sinica, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Patient recruitment	Recruitment: the proportion of patients who are eligible and invited actually consent to participate.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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