Skip to main content
OpenTrials
Completed

NCT Number: NCT05530018

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Suicide and Self-harm Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The acceptability of the intervention to participants

    Time frame: within 3 months of study completion

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

  2. The feasibility of intervention to participants

    Time frame: within 3 months of study completion

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

  3. Participant recruitment

    Time frame: through study completion, an average of 1 year

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

  4. Participant retention rate

    Time frame: 3 month

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

  5. Participant retention rate

    Time frame: 6 month

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

  6. Number of repeated self-harm episodes (self-report)

    Time frame: 3 month

    Number of repeated self-harm episodes per person at 3 month after intervention based on self-report.

  7. Number of repeated self-harm episodes (self-report)

    Time frame: 6 month

    Number of repeated self-harm episodes per person at 6 month after intervention based on self-report.

  8. Number of repeated self-harm episodes (nationwide self-harm registry)

    Time frame: 3 month

    Number of repeat self-harm episodes per person at 3 month after intervention recorded in the nationwide self-harm registry

  9. Number of repeated self-harm episodes (nationwide self-harm registry)

    Time frame: 6 month

    Number of repeat self-harm episodes per person at 6 month after intervention recorded in the nationwide self-harm registry

Secondary outcomes

  1. Self-Efficacy to Avoid Suicidal Action (SEASA)

    Time frame: From enrollment to 3 months and 6 months

    Access participants' self-efficacy and stages of change in relation to suicide ideation and attempt at baseline/3/6 month.

    The total score ranges from 0 to 24, with a score of 24 indicating the highest self-efficacy in controlling suicidal thoughts.

  2. Help-seeking behavior questionnaire

    Time frame: From enrollment to 3 months and 6 months

    Assess the help-seeking behaviours of participants at baseline/3/6 month. The total score ranges from 0 to 9, with a score of 9 indicating the highest level of help-seeking behaviors (knowing how to help oneself and where to access resources).

  3. Brief Symptom Rating Scale (BSRS)

    Time frame: From enrollment to 3 months and 6 months

    Briefly evaluate the psychological distresses of participants at baseline/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.

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

    Time frame: From enrollment to 3 months and 6 months

    Measure the current mental wellbeing of participants at baseline/3/6 month. The total score ranges from 0 to 25, with a score of 25 indicating the best quality of life.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 7, 2022
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.