CClinicalTrials.gg
CompletedNCT05530018Updated Aug 14, 2025

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

An interventional study of Brief contact intervention in Suicide and Self-harm, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Suicide and Self-harm

Keywords

  • self-harm
  • psychological intervention
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 24 is below the median of 104 across 560 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Brief contact intervention

Interventions

  • BehavioralBrief 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 3 months of study completion

  2. The feasibility of intervention to participants

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

    Time frame: within 3 months of study completion

  3. Participant recruitment

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

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

  4. Participant retention rate

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

    Time frame: 3 month

  5. Participant retention rate

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

    Time frame: 6 month

  6. 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.

    Time frame: 3 month

  7. 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.

    Time frame: 6 month

  8. 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

    Time frame: 3 month

  9. 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

    Time frame: 6 month

Secondary outcomes

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

    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.

    Time frame: From enrollment to 3 months and 6 months

  2. Help-seeking behavior questionnaire

    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).

    Time frame: From enrollment to 3 months and 6 months

  3. Brief Symptom Rating Scale (BSRS)

    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.

    Time frame: From enrollment to 3 months and 6 months

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

    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.

    Time frame: From enrollment to 3 months and 6 months

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05530018
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Sep 7, 2022
Start date
Sep 19, 2022
Primary completion
Jan 15, 2025
Completion
Jan 15, 2025
Last update
Aug 14, 2025

Study contacts

Shu-Sen Chang, MD, MSc, PhD
principal investigator · National Taiwan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion