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

Not Applicable

Completed

• Conditions: Suicide and Self-harm

• Registration Number: NCT05530018
• Lead Sponsor: National Taiwan University Hospital

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.

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.

Study Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2022-09-19
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-08-10
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The acceptability of the intervention to participants	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	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	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	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)	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)	6 month	Number of repeat self-harm episodes per person at 6 month after intervention recorded in the nationwide self-harm registry

Secondary Outcome Measures

Name	Time	Method
Self-Efficacy to Avoid Suicidal Action (SEASA)	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.
Help-seeking behavior questionnaire	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).
Brief Symptom Rating Scale (BSRS)	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.
The World Health Organisation- Five Well-Being Index (WHO-5)	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan