NCT06817278

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Nonsuicidal Self-Injury
• Self-Harm

Interventions

Type	Name	Description
BEHAVIORAL	Adaptable IERITA	IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support. The adapted IERITA intervention is tailored to the participant and can thus entail different adaptions for different participants. Adaptions can entail changes in therapist contact, what material to focus on, and how to work with the treatment. The adapted IERITA intervention is offered between week four and 12.
BEHAVIORAL	Standard IERITA	IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support.
OTHER	Treatment as usual	Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.

Timeline

• Start date: 2025-01-15
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-02-10
• Last updated: 2025-11-28

Locations

1 site across 1 country: Sweden