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

NCT ID: NCT05530018

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2025-01-15

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:

1. To establish a co-design team and develop a brief contact intervention (BCI), including the content, frequency, settings, and outcome measures of the intervention.

2. 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:

1. 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.

2. 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.

Conditions

Suicide and Self-harm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BCI group

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.

Group Type: EXPERIMENTAL

Brief contact intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Brief contact intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shu-Sen Chang, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202206137RINA

Identifier Type: -

Identifier Source: org_study_id