Suicide and Self-harmNCT05530018
Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.
A study testing Brief contact intervention in people with Suicide and Self-harm, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Suicide and Self-harm
- What is being tested?
- Brief contact intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2022to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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.
- Conditions
- Suicide and Self-harm
- Being tested
- Brief contact intervention
- Keywords
- self-harm, psychological intervention
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief contact interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Brief contact intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 3 months of study completion
Participant recruitment
Recruitment: the proportion of participants who are eligible and invited actually consent to participate.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 month
Secondary outcomes (4)
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.
Measured: From enrollment to 3 months and 6 months
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).
Measured: From enrollment to 3 months and 6 months
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.
Measured: From enrollment to 3 months and 6 months
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.
Measured: From enrollment to 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start19 Sep 2022
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide and Self-harmStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Sen Chang, MD, MSc, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530018
- Sponsor's protocol ID
- 202206137RINA
- Status last verified
- Jul 2025
- First submitted
- 31 Aug 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.
- ClinicalTrials.gov ID
- NCT05530018
- Acronym / sponsor ID
- 202206137RINA
- Conditions
- Suicide and Self-harm
- Keywords
- self-harm, psychological intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCI group | Experimental | Behavioral: Brief contact interventionParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief contact interventionThe 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. | Behavioural | BCI group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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
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
4 secondary outcomes
Self-Efficacy to Avoid Suicidal Action (SEASA)
Time frame: From enrollment to 3 months and 6 months
Help-seeking behavior questionnaire
Time frame: From enrollment to 3 months and 6 months
Brief Symptom Rating Scale (BSRS)
Time frame: From enrollment to 3 months and 6 months
The World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: From enrollment to 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Sen Chang, MD, MSc, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief contact intervention in people with Suicide and Self-harm, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acceptability of the intervention to participants (time frame: within 3 months of study completion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.