Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services: Pilot Study

Last updated: May 20, 2026
Sponsor: Karolinska Institutet
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Suicide

Treatment

Adaptable IERITA

Treatment as usual

Standard IERITA

Clinical Study ID

NCT06817278
2024-01916
  • Ages 13-17
  • All Genders

Study Summary

The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and to optimize treatment outcomes for those adolescents at risk of insufficient effects. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 13-17 years old

  • At least one self-injury episode in the past three months

  • A parent willing to engage in the parent program

Exclusion

Exclusion Criteria:

  • Immediate suicide risk

  • Global functioning corresponding to a rating ≤40 of the Children's Global AssessmentScale (CGAS)

  • Social problems needing immediate intervention (e.g., violence within the family)

  • Ongoing dialectical behavior therapy for adolescents

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Adaptable IERITA
Phase:
Study Start date:
January 15, 2025
Estimated Completion Date:
December 31, 2036

Study Description

Self-injury without the intention to die is a growing and urgent global health crisis among youth. It is associated with substantial individual and societal costs, including increased risk of suicide attempts. Scalable and evidence-based treatments are needed but lacking. Digital interventions can be one promising solution. A recent study shows that a novel brief digital treatment, IERITA, can be efficacious compared to treatment as usual only. However, not all respond sufficiently to standardized treatment, such as IERITA, and continued self-injury entails risks and suffering.

In this randomized controlled pilot trial, participants will be randomly allocated (1:1) to standard IERITA or adaptable IERITA. All participants will first receive standard IERITA for four weeks. In treatment week four, non-remission will be predicted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA for the remaining eight weeks while all other participants will continue standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment. The primary endpoint is one-month post-treatment.

The main objective is to investigate the project's feasibility and test key components. The specific objectives are:

  1. Examine the feasibility of the project (treatment satisfaction and adherence, degree of participation in data collection, and level of resources).

  2. Explore the utility of adapted IERITA compared to standard IERITA for adolescents at risk of non-remission.

  3. Evaluate the performance of the algorithm predicting treatment non-remission.

This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2024-01916)

Connect with a study center

  • Karolinska Institutet

    Stockholm, 113 64
    Sweden

    Site Not Available

  • Karolinska Institutet

    Stockholm 2673730, 113 64
    Sweden

    Site Not Available

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