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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05530018
Other study ID # 202206137RINA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 19, 2022
Est. completion date July 2024

Study information

Verified date September 2022
Source National Taiwan University Hospital
Contact Shu-Sen Chang, MD, MSc, PhD
Phone +886 2 33668062
Email shusenchang@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months of study completion
Primary The feasibility of intervention to participants The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention amongst participants. within 6 months of study completion
Primary Participant recruitment Recruitment: the proportion of participants who are eligible and invited actually consent to participate. through study completion, an average of 1 year
Primary Participant retention rate The proportion of participants who can be reached by in-person or phone contact at the 1 month follow-up. 1 month
Primary 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
Primary 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
Primary Number of repeated self-harm episodes (self-report) Number of repeated self-harm episodes per person at 1 month after intervention based on self-report. 1 month
Primary 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
Primary 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
Primary Number of repeated self-harm episodes (nationwide self-harm registry) Number of repeat self-harm episodes per person at 1 month after intervention recorded in the nationwide self-harm registry 1 month
Primary 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
Primary 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 Self-efficacy and stages of change questionnaire Access participants' self-efficacy and stages of change in relation to suicide ideation and attempt at 1/3/6 month. 1 month, 3 months, 6 months
Secondary Help-seeking behavior questionnaire Assess the help-seeking behaviors of participants at 1/3/6 month. 1 month, 3 months, 6 months
Secondary Brief Symptom Rating Scale (BSRS) Briefly evaluate the psychological distresses of participants at 1/3/6 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. 1 month, 3 months, 6 months
Secondary The World Health Organisation- Five Well-Being Index (WHO-5) Measure the current mental wellbeing of participants at 1/3/6 month. 1 month, 3 months, 6 months
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