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

NCT07573085 | Not Yet Recruiting

• 1 other identifier: 2024-04650-01
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

Brief 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 optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).

Conditions

Nonsuicidal Self-Injury; Self-Harm

Keywords

Nonsuicidal self-injury; Internet-delivered treatment; Self-harm; Adolescence

Outcome Measures

Primary Outcomes (1)

• Deliberate Self-harm Inventory - Youth version (DSHI-Y)

  The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.

  One-, three- and twelve-months post-treatment

Secondary Outcomes (8)

• Deliberate Self-harm Inventory - Youth version (DSHI-Y)

  Baseline, one-, three- and twelve-months post-treatment

• Children's Global Assessment Scale (CGAS)

  Baseline, one-, three- and twelve-months post-treatment

• Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)

  Baseline, one-, three- and twelve-months post-treatment

• Child Health Utility 9D (CHU-9D)

  Baseline, one-, three- and twelve-months post-treatment

• Borderline symtom checklist supplement (BSL)

  Baseline, one-, three- and twelve-months post-treatment

Other Outcomes (32)

• Internet Intervention Patient Adherence Scale (iiPAS)

  Treatment week 3 and post-treatment (week 12)

• Participant-rated adherence

  Treatment week 3

• Credibility

  Treatment week 3

Study Arms (2)

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

EXPERIMENTAL

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 (or earlier if the adolescent is at risk of discontinuation). 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.

Behavioral: Adaptable IERITA; Other: Treatment as usual

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

ACTIVE COMPARATOR

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.

Behavioral: Standard IERITA; Other: Treatment as usual

Interventions

Adaptable IERITA BEHAVIORAL

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. In the adapted IERITA intervention, the therapists develop an individual case conceptualization that forms the basis for a brief interview with the adolescent after the classification phase (from randomization to treatment week four), during which potential obstacles and necessary adaptations are explored. Adaption can entail scheduled or regular chats or videoconferences, selecting specific material to focus on, and involving additional support persons. The adapted IERITA intervention is offered after the classification phase until treatment week 12.

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

Standard IERITA BEHAVIORAL

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.

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

Treatment as usual OTHER

Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.

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

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• At least one self-injury episode in the past three months
• A parent willing to engage in the parent program

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Region Skane: collaborator
• Vastra Gotaland Region: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 113 64, Sweden

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Johan Bjureberg, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Olivia Ojala, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Ojala, PhD

CONTACT

+46761426565; olivia.ojala@ki.se

Johan Bjureberg, PhD

CONTACT

+460852480000; johan.bjureberg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Therapists will be partially blinded. They will be blinded to treatment allocation and participant classification until treatment week 4, or until a participant is classified as a likely non-remission. At treatment week 4, blinding will be broken only for the subset of participants classified as likely non-remission who are allocated to the adaptable IERITA condition. Therapists will remain blinded to allocation and classification for most participants throughout the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2040
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)