Clinical trial NCT03376113: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide and Self-harm
Keywords: self-harm
psychological intervention
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Academia Sinica, Taiwan
First posted: 2017-12-18
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The acceptability of the intervention to patients
timeFrame: within 6 months of study completion
measure: The feasibility of intervention delivery at the ER setting
timeFrame: within 6 months of study completion
measure: Patient recruitment
timeFrame: Baseline
measure: The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up.
timeFrame: 3 months
measure: The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up.
timeFrame: 6 months
measure: The proportion of participating patients who can be traced from the hospital record at the 3-month.
timeFrame: 3 months
measure: The proportion of participating patients who can be traced from the hospital record at the 6-month.
timeFrame: 6 months
measure: The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month.
timeFrame: 6 months
measure: The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month.
timeFrame: 3 months
measure: Change in scores on a self-report suicidal behaviors assessment from baseline to 3 months
timeFrame: Baseline, 3 months
measure: Change in scores on a self-report suicidal behaviors assessment from baseline to 6 months
timeFrame: Baseline, 6 months
measure: Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records
timeFrame: 3 months
measure: Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry
timeFrame: 3 months
measure: Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records
timeFrame: 6 months
measure: Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry
timeFrame: 6 months
measure: Time to next self-harm repetition (in days) following randomization
timeFrame: 6 months
Secondary outcomes:
measure: Times of use of the volitional help sheet
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shu-Sen Chang, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.