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

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ClinicalTrials.gov Identifier: NCT03376113
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Academia Sinica, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Suicide and Self-harm Behavioral: the volitional help sheet Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility Study
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm Suicide

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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Patient recruitment [ Time Frame: Baseline ]
    Recruitment: the proportion of patients who are eligible and invited actually consent to participate.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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.


Secondary Outcome Measures :
  1. Times of use of the volitional help sheet [ Time Frame: 6 months ]
    Times of use of the volitional help sheet based on the number of visits to the individualized website of the volitional help sheet.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376113


Contacts
Contact: Shu-Sen Chang, MD, MSc, PhD +886 2 33668062 shusenchang@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Shu-Sen Chang, MD, MSc, PhD    +886 2 33668062    shusenchang@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Academia Sinica, Taiwan
Investigators
Principal Investigator: Shu-Sen Chang, MD, MSc, PhD National Taiwan University

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03376113     History of Changes
Other Study ID Numbers: 201708008RINB
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
self-harm
psychological intervention

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms