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Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial

Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial

Recruiting
12-17 years
All
Phase N/A

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Overview

The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

Description

NSSI is a growing health crisis among youth and the strongest risk factor for suicide attempts. Scalable and evidence-based treatments are needed but lacking. We have recently shown that a brief digital treatment, Internet-delivered ERITA, can be efficacious compared to treatment as usual only.

However, digital treatment is not suitable for everyone. Adolescents with low levels of functioning have trouble engaging in text-based therapy independently from home. A blended format, which combines in-person and online treatment, may enhance effectiveness; therapists can tailor delivery of material, and adolescents can access the skills when necessary.

This project aims to develop and evaluate a blended version of ERITA - blended ERITA - for adolescents with low levels of functioning. The specific objectives of this pilot study are:

Primary
  • Evaluate the feasibility of the project (i.e., data proportion at the primary endpoint, adherence, treatment completion, and therapist time)
  • Evaluate acceptability of blended ERITA (i.e., satisfaction, credibility, negative effects)
Secondary

\- Provide explorative data on the utility of blended ERITA and treatment as usual.

This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2025-01507).

The protocol including statistical analysis plan is found at: https://osf.io/e6wjq/overview

Eligibility

Inclusion Criteria:

  • 12-17 years old
  • At least one NSSI episode in the past three months
  • A parent willing to engage in the parent program
  • Global functioning corresponding to a rating ≤50 of the Children's Global Assessment Scale (CGAS)

Exclusion Criteria:

  • Immediate suicide risk
  • Social problems needing immediate intervention (e.g., violence within the family)
  • Other psychiatric disorder or symptoms requiring immediate treatment (e.g., severe anorexia nervosa, acute psychosis, severe substance abuse)
  • Ongoing dialectical behavior therapy for adolescents

Study details
    Nonsuicidal Self Injury
    Nonsuicidal Self-Injury
    Self-Harm

NCT07755774

Karolinska Institutet

20 October 2026

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