Brief mobile app-based intervention for non-suicidal self-injury

Design and analysis of the effectiveness of a brief mobile App-based intervention for Non-Suicidal Self-Injury: self-report, momentary and biological predictors of treatment outcomes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63093907

Enrollment

300

Registered

2025-03-13

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-suicidal self-injury Injury, Occupational Diseases, Poisoning

Interventions

This study is a randomized controlled trial (RCT) designed to evaluate the effectiveness of two App-based interventions for non-suicidal self-injury (NSSI) in adolescents and young adults. Participant

(ii) The Inventory of Statements About Self-Injury (ISAS) to evaluate lifetime frequency and functions of NSSI. Additionally, participants will undergo a structured diagnostic interview (Mini-Internat

Eligibility

Sex/Gender

All

Age

14 Years to 24 Years

Inclusion criteria

Inclusion criteria: For all participants: 1. From 14 to 24 years old 2. Provide informed consent (including parental consent for participants under 18) 3. Have access to a mobile phone. For the control group: 1. No history of non-suicidal self-injury (NSSI), either past or present 2. Not receiving any psychological or psychiatric treatment. For the subclinical group: 1. Have engaged in NSSI on at least five days during the last 12 months 2. Not receiving psychological or psychiatric treatment. For the clinical group 1. Have engaged in NSSI on at least five days during the last 12 months 2. Under psychological or psychiatric treatment

Exclusion criteria

Exclusion criteria: For participants eligible to neuroimaging: 1. Pregnancy 2. Neurological disorders 3. Claustrophobia 4. Metal implants or medical devices For the clinical group: 1. Important clinical instability at the time of recruitment

Design outcomes

Primary

Measure	Time frame
Frequency of non-suicidal self-injury (NSSI) episodes and thoughts is measured using Momentary Assessments via the App (participants will report NSSI behaviors and thoughts in real-time throughout the intervention phase) and Self-Report Measures at baseline, 1 week, 5 weeks, 9 weeks (1 months follow-up) and 17 weeks (3 months follow-up).	—

Secondary

Measure	Time frame
1. Emotional Regulation and Psychological Symptoms measured using self-report questionnaires at baseline, 1 week, 5 weeks, 9 weeks (1 months follow-up) and 17 weeks (3 months follow-up) 2. Emotional Regulation and Psychological Symptoms measured using momentary assessments (participants will report their emotional status through the App to track changes over time) at baseline, 1 week and 5 weeks 3. Neural pain processing and social rejection processing as biological predictors of treatment measured using Neuroimaging Measures (fMRI) at baseline 4. Engagement and Treatment Adherence using App Usage Metrics after treatment ends (ie., 5 weeks) 5. Risk of non-suicidal self-injury engagement using momentary data and neuroimaging features after ends the follow-ups	—

Measure

Time frame

1. Emotional Regulation and Psychological Symptoms measured using self-report questionnaires at baseline, 1 week, 5 weeks, 9 weeks (1 months follow-up) and 17 weeks (3 months follow-up) 2. Emotional Regulation and Psychological Symptoms measured using momentary assessments (participants will report their emotional status through the App to track changes over time) at baseline, 1 week and 5 weeks 3. Neural pain processing and social rejection processing as biological predictors of treatment measured using Neuroimaging Measures (fMRI) at baseline 4. Engagement and Treatment Adherence using App Usage Metrics after treatment ends (ie., 5 weeks) 5. Risk of non-suicidal self-injury engagement using momentary data and neuroimaging features after ends the follow-ups

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Countries

Spain

Contacts

Public ContactDaniel Vega

recerca@fsigualada.org+34-938075500

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026