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

NCT05530018 | Completed

• 1 other identifier: 202206137RINA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide and Self-harm

Keywords

self-harm; psychological intervention

Outcome Measures

Primary Outcomes (9)

• 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.

  within 3 months of study completion

• The feasibility of intervention to participants

  The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention amongst participants.

  within 3 months of study completion

• Participant recruitment

  Recruitment: the proportion of participants who are eligible and invited actually consent to participate.

  through study completion, an average of 1 year

• Participant retention rate

  The proportion of participants who can be reached by in-person or phone contact at the 3 month follow-up.

  3 month

• Participant retention rate

  The proportion of participants who can be reached by in-person or phone contact at the 6 month follow-up.

  6 month

• 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.

  3 month

• 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.

  6 month

• 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

  3 month

• 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

  6 month

Secondary Outcomes (4)

• Self-Efficacy to Avoid Suicidal Action (SEASA)

  From enrollment to 3 months and 6 months

• Help-seeking behavior questionnaire

  From enrollment to 3 months and 6 months

• Brief Symptom Rating Scale (BSRS)

  From enrollment to 3 months and 6 months

• The World Health Organisation- Five Well-Being Index (WHO-5)

  From enrollment to 3 months and 6 months

Study Arms (1)

BCI group

EXPERIMENTAL

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.

Behavioral: Brief contact intervention

Interventions

Brief contact intervention 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.

BCI group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Shu-Sen Chang, MD, MSc, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 7, 2022
• Study Start: September 19, 2022
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-07

Locations

TW (1)