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

NCT06817278 | Recruiting

• 1 other identifier: 2024-01916
• Study Type: interventional
• Target: 100
• 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 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.

Conditions

Nonsuicidal Self-Injury; Self-Harm

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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. Clinician-rated.

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

• Internet Intervention Patient Adherence Scale (iiPAS)

  The IIPAS measures patient adherence to guided internet-delivered behavioral interventions. This scale has 5 items, and a total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. Clinician-rated.

  Treatment week 3 and post-treatment (week 12)

• Credibility/Expectancy Questionnaire (CEQ) - 1 item version

  CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).

  Treatment week 3

• The Client Satisfaction Questionnaire (CSQ)

  The CSQ measures satisfaction with treatment. This scale has 8 items and a summary score ranging from 8 to 32, with higher scores indicating greater treatment satisfaction. Self-rated (adolescent and parent).

  Post-treatment (week 12)

• Therapist time

  Clinicians report time spent on treatment.

  Post-treatment (week 12)

• Number of completed sessions and modules

  Clinicians report number of completed sessions and modules for adolescents and parents.

  Post-treatment (week 12)

• Rate of treatment adaptions

  Clinicians report presence or absence of possible treatment adaptions (e.g., changes in therapist contact or what material to focus on).

  Post-treatment (week 12)

• Degree of partcipation in data collection

  The proportion of adolescents completing the primary clinical outcome, Deliberate Self-harm Inventory - Youth version, either through interview or self-report questionnaire at one-month post-treatment

  One-month post-treatment

• Adapted ICBT Therapist Rating Scale (ICBT-TRS)

  Therapist behaviors are rated separately as 0 (absence of behavior), 1 (inadequate performance), or 2 (competent). Rated by experienced clinical supervisors.

  Through study completion, an average of 1 year

Secondary Outcomes (9)

• 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 (23)

• Participant-rated adherence

  Treatment week 3

• Credibility

  Treatment week 3

• Adverse events

  Post-treatment (week 12)

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. 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. 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.

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

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Olivia Ojala, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Johan Bjureberg, 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: Participants and outcome assessors will be masked to allocation and classification. Therapists will be masked until treatment week four.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 10, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)