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Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.

Primary Purpose

Suicide and Self-harm

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Brief contact intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide and Self-harm focused on measuring self-harm, psychological intervention

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 20 years or over
  • Mentally and physically stable and able to participate in individual interviews and interventions
  • Able to communicate in Mandarin and provide written informed consent
  • Willing to be recorded during the interviews
  • Received medical treatments or aftercare due to self-harm experiences, including self-harm ideations, self-harm behaviors, suicidal ideations, and suicidal attempts.
  • Able to use the smartphone to access the internet

Exclusion Criteria:

  • Mental and physical states are unstable (e.g., unconscious, severe psychiatric symptoms, strong suicidal ideations with specific suicide plans) to complete the interviews and interventions according to the health professionals.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BCI group

Arm Description

Participants will be asked to participate in a brief contact intervention and to evaluate its feasibility, including the feasibility of recruitment, intervention resources, the appropriateness of data collection, and the acceptance of the intervention.

Outcomes

Primary Outcome Measures

The acceptability of the intervention to participants
The investigators will conduct face-to-face qualitative interviews to understand the acceptability of the intervention amongst participants.
The feasibility of intervention to participants
The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention amongst participants.
Participant recruitment
Recruitment: the proportion of participants who are eligible and invited actually consent to participate.
Participant retention rate
The proportion of participants who can be reached by in-person or phone contact at the 1 month follow-up.
Participant retention rate
The proportion of participants who can be reached by in-person or phone contact at the 3 month follow-up.
Participant retention rate
The proportion of participants who can be reached by in-person or phone contact at the 6 month follow-up.
Number of repeated self-harm episodes (self-report)
Number of repeated self-harm episodes per person at 1 month after intervention based on self-report.
Number of repeated self-harm episodes (self-report)
Number of repeated self-harm episodes per person at 3 month after intervention based on self-report.
Number of repeated self-harm episodes (self-report)
Number of repeated self-harm episodes per person at 6 month after intervention based on self-report.
Number of repeated self-harm episodes (nationwide self-harm registry)
Number of repeat self-harm episodes per person at 1 month after intervention recorded in the nationwide self-harm registry
Number of repeated self-harm episodes (nationwide self-harm registry)
Number of repeat self-harm episodes per person at 3 month after intervention recorded in the nationwide self-harm registry
Number of repeated self-harm episodes (nationwide self-harm registry)
Number of repeat self-harm episodes per person at 6 month after intervention recorded in the nationwide self-harm registry

Secondary Outcome Measures

Self-efficacy and stages of change questionnaire
Access participants' self-efficacy and stages of change in relation to suicide ideation and attempt at 1/3/6 month.
Help-seeking behavior questionnaire
Assess the help-seeking behaviors of participants at 1/3/6 month.
Brief Symptom Rating Scale (BSRS)
Briefly evaluate the psychological distresses of participants at 1/3/6 month. The total score ranges from 0 to 25. Categorized as "mild" with score 6-9, "moderate" with score 10-14, and "severe" with score more than 15.
The World Health Organisation- Five Well-Being Index (WHO-5)
Measure the current mental wellbeing of participants at 1/3/6 month.

Full Information

First Posted
August 31, 2022
Last Updated
September 29, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05530018
Brief Title
Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.
Official Title
Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Suicide is a major public health issue. Repeated self-harm may lead to potential future suicide deaths. In addition, it may lead to substantial loss in medical costs. Recently, smartphones have been widely used. Researchers started to apply mobile health to support individuals with self-harm experiences and to combine brief contact interventions which require lower cost to reduce repeated self-harm. However, the research evidence remains sparse. Furthermore, self-harm behaviors might be influenced by different cultural contexts. There is a need to conduct local studies in Taiwan. The aim of this study is to establish a co-design team which includes service users and service providers, to collaboratively develop a text- and web-based brief contact intervention (BCI) to reduce repeated self-harm, and to evaluate the feasibility of the intervention.
Detailed Description
Study objectives: To establish a co-design team and develop a brief contact intervention (BCI), including the content, frequency, settings, and outcome measures of the intervention. To evaluate the feasibility of BCI, including the feasibility of recruitment, required resources, the appropriateness of data collection, and the acceptability of the BCI. Methods: In study 1, we will recruit 4-6 service users and 4-6 service providers respectively, and we will conduct focus groups to discuss the content of the BCI. We will conduct individual interviews with participants to explore their experiences and perspectives regarding their participation in the co-design team. In study 2, we will recruit 30 participants who have self-harm experiences to participate in the BCI. The BCI will be delivered through texts and web pages and will last around 5 months. The content of BCI will include caring messages, reminders of appointments, safety planning, volitional help sheet, and resources information. We will collect user engagement data and compare study outcomes (e.g., suicidal ideation and behaviors, brief symptom rating scale (BSRS), and mental well-being scale) before and after receiving the BCI. We will collect the participants' feedback regarding the BCI and evaluate the required resources to further revise the BCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm
Keywords
self-harm, psychological intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCI group
Arm Type
Experimental
Arm Description
Participants will be asked to participate in a brief contact intervention and to evaluate its feasibility, including the feasibility of recruitment, intervention resources, the appropriateness of data collection, and the acceptance of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Brief contact intervention
Intervention Description
The brief contact intervention (BCI) will send out text messages to the participants. The text messages will include caring messages, reminders of appointments, and a link to a web page. The web page is anticipated to include safety planning, volitional helpsheet, and resources information. The text messages are anticipated to send out to the participants on a weekly base for 6 weeks in a row, and then change to monthly reminders. The monthly reminders are anticipated to include caring messages, reminders of appointments, and invitations to encourage the participants to click the previous web links again. The monthly reminders are anticipated to send out to the participants three times in a row. In the final reminder, the participants will be told that this intervention is going to end. In total, the participants will receive 9 texts within 5 months.
Primary Outcome Measure Information:
Title
The acceptability of the intervention to participants
Description
The investigators will conduct face-to-face qualitative interviews to understand the acceptability of the intervention amongst participants.
Time Frame
within 6 months of study completion
Title
The feasibility of intervention to participants
Description
The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention amongst participants.
Time Frame
within 6 months of study completion
Title
Participant recruitment
Description
Recruitment: the proportion of participants who are eligible and invited actually consent to participate.
Time Frame
through study completion, an average of 1 year
Title
Participant retention rate
Description
The proportion of participants who can be reached by in-person or phone contact at the 1 month follow-up.
Time Frame
1 month
Title
Participant retention rate
Description
The proportion of participants who can be reached by in-person or phone contact at the 3 month follow-up.
Time Frame
3 month
Title
Participant retention rate
Description
The proportion of participants who can be reached by in-person or phone contact at the 6 month follow-up.
Time Frame
6 month
Title
Number of repeated self-harm episodes (self-report)
Description
Number of repeated self-harm episodes per person at 1 month after intervention based on self-report.
Time Frame
1 month
Title
Number of repeated self-harm episodes (self-report)
Description
Number of repeated self-harm episodes per person at 3 month after intervention based on self-report.
Time Frame
3 month
Title
Number of repeated self-harm episodes (self-report)
Description
Number of repeated self-harm episodes per person at 6 month after intervention based on self-report.
Time Frame
6 month
Title
Number of repeated self-harm episodes (nationwide self-harm registry)
Description
Number of repeat self-harm episodes per person at 1 month after intervention recorded in the nationwide self-harm registry
Time Frame
1 month
Title
Number of repeated self-harm episodes (nationwide self-harm registry)
Description
Number of repeat self-harm episodes per person at 3 month after intervention recorded in the nationwide self-harm registry
Time Frame
3 month
Title
Number of repeated self-harm episodes (nationwide self-harm registry)
Description
Number of repeat self-harm episodes per person at 6 month after intervention recorded in the nationwide self-harm registry
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Self-efficacy and stages of change questionnaire
Description
Access participants' self-efficacy and stages of change in relation to suicide ideation and attempt at 1/3/6 month.
Time Frame
1 month, 3 months, 6 months
Title
Help-seeking behavior questionnaire
Description
Assess the help-seeking behaviors of participants at 1/3/6 month.
Time Frame
1 month, 3 months, 6 months
Title
Brief Symptom Rating Scale (BSRS)
Description
Briefly evaluate the psychological distresses of participants at 1/3/6 month. The total score ranges from 0 to 25. Categorized as "mild" with score 6-9, "moderate" with score 10-14, and "severe" with score more than 15.
Time Frame
1 month, 3 months, 6 months
Title
The World Health Organisation- Five Well-Being Index (WHO-5)
Description
Measure the current mental wellbeing of participants at 1/3/6 month.
Time Frame
1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 20 years or over Mentally and physically stable and able to participate in individual interviews and interventions Able to communicate in Mandarin and provide written informed consent Willing to be recorded during the interviews Received medical treatments or aftercare due to self-harm experiences, including self-harm ideations, self-harm behaviors, suicidal ideations, and suicidal attempts. Able to use the smartphone to access the internet Exclusion Criteria: Mental and physical states are unstable (e.g., unconscious, severe psychiatric symptoms, strong suicidal ideations with specific suicide plans) to complete the interviews and interventions according to the health professionals.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Sen Chang, MD, MSc, PhD
Phone
+886 2 33668062
Email
shusenchang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Sen Chang, MD, MSc, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Sen Chang, MD, MSc, PhD
Phone
+886 2 33668062
Email
shusenchang@ntu.edu.tw

12. IPD Sharing Statement

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Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.

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