Clinical trial NCT05530018: Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.
Official title: Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide and Self-harm
Keywords: self-harm
psychological intervention
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The acceptability of the intervention to participants
timeFrame: within 6 months of study completion
measure: The feasibility of intervention to participants
timeFrame: within 6 months of study completion
measure: Participant recruitment
timeFrame: through study completion, an average of 1 year
measure: Participant retention rate
timeFrame: 1 month
measure: Participant retention rate
timeFrame: 3 month
measure: Participant retention rate
timeFrame: 6 month
measure: Number of repeated self-harm episodes (self-report)
timeFrame: 1 month
measure: Number of repeated self-harm episodes (self-report)
timeFrame: 3 month
measure: Number of repeated self-harm episodes (self-report)
timeFrame: 6 month
measure: Number of repeated self-harm episodes (nationwide self-harm registry)
timeFrame: 1 month
measure: Number of repeated self-harm episodes (nationwide self-harm registry)
timeFrame: 3 month
measure: Number of repeated self-harm episodes (nationwide self-harm registry)
timeFrame: 6 month
Secondary outcomes:
measure: Self-efficacy and stages of change questionnaire
timeFrame: 1 month, 3 months, 6 months
measure: Help-seeking behavior questionnaire
timeFrame: 1 month, 3 months, 6 months
measure: Brief Symptom Rating Scale (BSRS)
timeFrame: 1 month, 3 months, 6 months
measure: The World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shu-Sen Chang, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: