Suicide and Self-harmNCT03376113
The Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility Study
A study testing the volitional help sheet in people with Suicide and Self-harm, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Suicide and Self-harm
- What is being tested?
- the volitional help sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Nov 2017to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With self-harm experience in the past month
- Aged 20 years or over
- Admitted to the ER following an episode of self-harm
- Aged 20 years or over
Who cannot join
- With severe hallucinations or delusions or medically unfit for interview
- Limited hands movement (e.g. seriously wounded wrists)
- In phase II
- With severe hallucinations or delusions or medically unfit for interview
- Limited hands movement (e.g. seriously wounded wrists)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Shu-Sen Chang, MD, MSc, PhD, +886 2 33668062, shusenchang@ntu.edu.tw
About this 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.
Read the 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.
- Conditions
- Suicide and Self-harm
- Being tested
- the volitional help sheet
- Keywords
- self-harm, psychological intervention
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the volitional help sheetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VHS group | Experimental | Patients will be asked to make links between critical situations and appropriate solutions in the volitional help sheet (VHS). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 6 months of study completion
Patient recruitment
Recruitment: the proportion of patients who are eligible and invited actually consent to participate.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start3 Nov 2017
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide and Self-harmStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academia Sinica, Taiwan
- Responsible party
- Sponsor
- Investigators
- Shu-Sen Chang, MD, MSc, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376113
- Sponsor's protocol ID
- 201708008RINB
- Status last verified
- Oct 2017
- First submitted
- 2 Nov 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33884617Storebo 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.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility Study
- ClinicalTrials.gov ID
- NCT03376113
- Acronym / sponsor ID
- 201708008RINB
- Conditions
- Suicide and Self-harm
- Keywords
- self-harm, psychological intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Academia Sinica, Taiwan
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VHS group | Experimental | Behavioral: the volitional help sheetPatients will be asked to make links between critical situations and appropriate solutions in the volitional help sheet (VHS). |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With self-harm experience in the past month
- Aged 20 years or over
- Admitted to the ER following an episode of self-harm
- Aged 20 years or over
Key exclusion criteria (5 listed)
- With severe hallucinations or delusions or medically unfit for interview
- Limited hands movement (e.g. seriously wounded wrists)
- In phase II
- With severe hallucinations or delusions or medically unfit for interview
- Limited hands movement (e.g. seriously wounded wrists)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the volitional help sheetA sheet includes two columns: one shows critical situations that easily trigger self-harm; other one shows appropriate solutions for patients to prevent self-harm. | Behavioural | VHS group |
Primary outcome
The acceptability of the intervention to patients
Time frame: within 6 months of study completion
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
Time frame: within 6 months of study completion
The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention delivery at the ER setting.
Patient recruitment
Time frame: Baseline
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.
Time frame: 3 months
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.
Time frame: 6 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 traced from the hospital record at the 3-month.
Time frame: 3 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 6-month.
Time frame: 6 months
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.
Time frame: 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 3-month.
Time frame: 3 months
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
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: 3 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 recorded in the nationwide self-harm registry
Time frame: 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 6 months after intervention based on hospital records
Time frame: 6 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 recorded in the nationwide self-harm registry
Time frame: 6 months
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 frame: 6 months
Time to next self-harm repetition (in days) following randomization according to hospital records and a nationwide self-harm registry.
1 secondary outcome
Times of use of the volitional help sheet
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Derived from this study: PubMed 33884617Witt 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.
- Derived from this study: PubMed 32368793Storebo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Sen Chang, MD, MSc, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the volitional help sheet in people with Suicide and Self-harm, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Sen Chang, MD, MSc, PhD (+886 2 33668062, shusenchang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acceptability of the intervention to patients (time frame: within 6 months of study completion). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376113, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.