Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial

NCT07755774 | Not Yet Recruiting

• 1 other identifier: 2025-01507
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching aim of this study is to develop and evaluate a new blended treatment format, which combines face-to-face and digital treatment components, for Emotion Regulation Individual Therapy for Adolescents (ERITA). This brief, transdiagnostic, and blended treatment targeting nonsuicidal self-injury (NSSI) - referred to as blended ERITA - will be specifically designed for adolescents with NSSI and low levels of functioning within intensive outpatient psychiatric services. The specific purpose of this pilot trial is to investigate feasibility in preparation for a larger trial.

Conditions

Nonsuicidal Self Injury; Nonsuicidal Self-Injury; Self-Harm

Keywords

Nonsuicidal self-injury; Self-harm; Psychological treatment; Adolescence

Outcome Measures

Primary Outcomes (7)

• Degree of participation in data collection

  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

• Treatment completion

  Proportion of adolescents completing ≥ six ERITA modules. Only in the experimental condition. Clinician-rated

  Post-treatment (week 20)

• Therapist time

  Therapists will report time for having sessions with adolescents and/or parents or giving feedback on the digital platform. Only in the experimental condition.

  Post-treatment (week 20)

• Credibility/Expectancy Questionnaire (CEQ)

  CEQ measures treatment credibility and expectancy. Scale points range from 0-9, and 0-100%, where higher scores indicate greater credibility and expectancy. Self-rated by adolescents. Only in the experimental condition.

  Week 2 (after first week in treatment)

• Emotion regulation therapy adherence checklist

  This checklist measures therapist adherence to emotion regulation therapy. Adapted to be suitable for therapy with adolescents. Only in the experimental condition.

  Through study completion, an average of 1 year

• Client Satisfaction Questionnarie (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-reported (adolescents and parents).

  Post-treatment (week 20)

• Adverse events

  A scale where participants are asked to report, describe, and rate the discomfort/impact of any negative effects or adverse events caused by their participation in the treatment. Participants rate the impact of potential adverse events when it happened and today on a scale from 1 to 4, where a higher score indicates greater impact. Self-reported (adolescents and parents). Adverse events will be recorded by PI throughout the treatment period.

  Post-treatment and through study completion, an average of 1 year

Secondary Outcomes (10)

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

  One- and three-months post-treatment

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

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

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

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

• Clinical Global Assessment Scale (CGAS)

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

• Borderline Symptom List - Behavior Supplement (BSL-Supplement)

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

Other Outcomes (5)

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

  Baseline

• Columbia-Suicide Severity Rating Scale (C-SSRS) - 6 item version

  Baseline

• Care consumption

  From enrollment to three-months post-treatment

Study Arms (2)

Blended Emotion Regulation Individual Therapy for Adolescents (ERITA)

EXPERIMENTAL

Participants will receive Blended Emotion Regulation Individual Therapy (ERITA) for 20 weeks. In addition to Blended ERITA, participants are free to will receive any type of concomitant care for 20 weeks as provided by the regular care services.

Behavioral: Blended ERITA; Other: Concomitant care

Treatment as usual

ACTIVE COMPARATOR

Participants will receive treatment as usual for NSSI for 20 weeks. In addition, participants are free to will receive any type of concomitant care for 20 weeks as provided by the regular care services.

Behavioral: Treatment as Usual (TAU); Other: Concomitant care

Interventions

Blended ERITA BEHAVIORAL

Blended ERITA is an acceptance-based behavioral therapy. The goal of ERITA is to reduce self-injury through learning and using other ways to regulate emotions. ERITA includes both an adolescent treatment and a separate parent course. The adolescent treatment includes skills training in emotional awareness, impulse control, emotional acceptance, emotional willingness, emotional modulation effectiveness and flexibility, validation, and valued direction. The parent course includes skills training in emotional awareness, validation, self-validation, and behavioral activation. The adolescent treatment is 11 modules, and the parent course is six. The modules include text, videos, and audio resources. The family and therapist decide on how to combine sessions with digital material based on preferences and needs.

Blended Emotion Regulation Individual Therapy for Adolescents (ERITA)

Treatment as Usual (TAU) BEHAVIORAL

Treatment as usual (TAU) will constitute treatment for NSSI according to local clinical guidelines.

Treatment as usual

Concomitant care OTHER

Participants are free to receive concomitant care (counselling or medication) in addition to self-injury treatment according to their needs during the trial.

Blended Emotion Regulation Individual Therapy for Adolescents (ERITA); Treatment as usual

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• At least one NSSI episode in the past three months
• A parent willing to engage in the parent program
• Global functioning corresponding to a rating ≤50 of the Children's Global Assessment Scale (CGAS)

You may not qualify if:

• Immediate suicide risk
• Social problems needing immediate intervention (e.g., violence within the family)
• Other psychiatric disorder or symptoms requiring immediate treatment (e.g., severe anorexia nervosa, acute psychosis, severe substance abuse)
• Ongoing dialectical behavior therapy for adolescents

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

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

Samantha Khoo

CONTACT

+4670-2355460; samantha.khoo@ki.se

Olivia Ojala, PhD

CONTACT

+46761426565; olivia.ojala@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)