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

Karolinska Institute

Status: Enrolling

Conditions: Nonsuicidal Self-Injury; Self-Harm

Treatments: Behavioral: Adaptable IERITA; Other: Treatment as usual; Behavioral: Standard IERITA

Study type: Interventional

Funder types: Other

Identifiers

NCT06817278

2024-01916

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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 criteria

• Immediate suicide risk
• Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS)
• Social problems needing immediate intervention (e.g., violence within the family)
• Ongoing dialectical behavior therapy for adolescents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual

Experimental group

Description:

Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. Adolescents allocated to experimental arm and classified as likely non-remission, will change to adapted IERITA in treatment week four. Adolescents allocated to experimental arm and classified as likely remission will continue standard IERITA. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community.

Treatment:

Other: Treatment as usual

Behavioral: Adaptable IERITA

Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual

Active Comparator group

Description:

Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. All participants will continue standard IERITA throughout the treatment period. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community.

Treatment:

Behavioral: Standard IERITA

Other: Treatment as usual