Clinical trial NCT06817278: Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services: Pilot Study
Official title: Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonsuicidal Self-Injury
Self-Harm
Keywords: Nonsuicidal self-injury
Internet-delivered treatment
Self-harm
Adolescence
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Region Skane
name: Vastra Gotaland Region
First posted: 2025-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Deliberate Self-harm Inventory - Youth version (DSHI-Y)
timeFrame: One-, three- and twelve-months post-treatment
measure: Internet Intervention Patient Adherence Scale (iiPAS)
timeFrame: Treatment week 3 and post-treatment (week 12)
measure: Credibility/Expectancy Questionnaire (CEQ) - 1 item version
timeFrame: Treatment week 3
measure: The Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-treatment (week 12)
measure: Therapist time
timeFrame: Post-treatment (week 12)
measure: Number of completed sessions and modules
timeFrame: Post-treatment (week 12)
measure: Rate of treatment adaptions
timeFrame: Post-treatment (week 12)
measure: Degree of partcipation in data collection
timeFrame: One-, three- and twelve-months post-treatment
measure: Adapted ICBT Therapist Rating Scale (ICBT-TRS)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Deliberate Self-harm Inventory - Youth version (DSHI-Y)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: Child Health Utility 9D (CHU-9D)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) - 6 item version
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: Borderline symtom checklist supplement (BSL)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: The Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: The Work and Social Adjustment Scale -Youth version (WSAS-Y)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: The Work and Social Adjustment Scale - Parent version (WSAS-P)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
Other outcomes:
measure: Participant-rated adherence
timeFrame: Treatment week 3
measure: Credibility
timeFrame: Treatment week 3
measure: Adverse events
timeFrame: Post-treatment (week 12)
measure: Concomitant treatment
timeFrame: Post-treatment (week 12), one- and three-months post-treatment
measure: The clinician's satisfaction with treatment adaptions
timeFrame: Post-treatment (week 12)
measure: Inventory of Statements About Self-injury (ISAS)
timeFrame: Baseline
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
timeFrame: Baseline, one-, three- and twelve-months post-treatment
measure: Academic performance
timeFrame: 1-10 years post-treatment
measure: Number of healthcare visits
timeFrame: 1-10 years post-treatment
measure: Prescription of psychotropics
timeFrame: 1-10 years post-treatment
measure: Mental health disorders
timeFrame: 1-10 years post-treatment
measure: Reasons for eventual death
timeFrame: 1-10 years post-treatment
measure: Suicide attempts
timeFrame: 1-10 years post-treatment
measure: Occupation
timeFrame: 1-10 years post-treatment
measure: The Revised Child Anxiety and Depression Scale (RCADS)
timeFrame: 1-10 years post-treatment
measure: Children's Global Assessment Scale (CGAS)
timeFrame: 1-10 years post-treatment
measure: Kidscreen-10
timeFrame: 1-10 years post-treatment
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Olivia Ojala, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Johan Bjureberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: