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A smartphone-based intervention for young people who self-harm ('PRIMARY'): study protocol for a multicenter
Anouk Aleva1,2, Tessa van den Berg3,4, Odilia M Laceulle3,4
1HYPE Centre of Expertise on Early Intervention for Borderline Personality Disorder, GGz Centraal, Amersfoort, The Netherlands. a.aleva@uu.nl.
BMC Psychiatry
|November 14, 2023
Summary
This study introduces PRIMARY, a smartphone intervention for young people experiencing self-harm. It aims to reduce self-harm incidents and improve emotion regulation and relationships, addressing a critical gap in mental health support.
Area of Science:
- Mental Health
- Digital Health Interventions
- Adolescent Psychology
Background:
- Self-harm in young people is a significant public health issue linked to severe mental health conditions.
- There is a lack of evidence-based interventions specifically for youth who self-harm.
- The PRIMARY intervention was co-designed with clinicians and young people with lived experience.
Purpose of the Study:
- To evaluate the effectiveness of the PRIMARY smartphone-based intervention.
- To assess PRIMARY's impact on reducing self-harm behaviors in young people.
- To determine if PRIMARY improves emotion regulation and the quality of relationships.
Main Methods:
- A multicenter, randomized controlled trial comparing PRIMARY to a waiting list control group.
- Participants (n=180, aged 12-25) with recent self-harm engaged in daily mobile monitoring (ESM) and weekly reports for 28 days.
- Assessments at baseline, 28 days, and 10 weeks post-treatment; stratified randomization by age group.
Main Results:
- Primary outcomes include reduction in self-harm, improvements in emotion regulation, and enhanced relationship quality.
- Secondary outcomes focus on patient and clinician satisfaction.
- Exploratory analyses will investigate the links between emotions, social interactions, and self-harm using ESM data.
Conclusions:
- The study will determine if the PRIMARY intervention effectively reduces self-harm and improves mental well-being in young people.
- Positive findings could establish PRIMARY as an accessible, low-cost treatment option, filling a crucial gap.
- ESM data will provide deeper insights into the mechanisms underlying self-harm.

