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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Self-Harm; Nonsuicidal Self-Injury
• Intervention / Treatment: Behavioral: Adaptable IERITA; Other: Treatment as usual; Behavioral: Standard IERITA

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)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 113 64
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual; 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; 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.; Other: Treatment as usual; Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.
Active Comparator: Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual; 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.	Other: Treatment as usual; Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.; Behavioral: Standard IERITA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deliberate Self-harm Inventory - Youth version (DSHI-Y)	The DSHI-Y measures the frequency of the most common NSSI behaviors. Change in NSSI frequency from baseline to respective follow-up will be a secondary outcome. Clinician-rated.	Baseline, one-, three- and twelve-months post-treatment
Children's Global Assessment Scale (CGAS)	The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.	Baseline, one-, three- and twelve-months post-treatment
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)	The DERS-16 measures difficulties in emotion regulation. The total score ranges from 16 to 80, with higher scores indicating greater difficulties. Self-rated (adolescent and parent).	Baseline, one-, three- and twelve-months post-treatment
Child Health Utility 9D (CHU-9D)	The CHU-9D measures health related quality of life. The scale has 9 items with a summary score between 9 and 45, where a higher score indicates greater health-related quality of life. Self-rated (adolescent).	Baseline, one-, three- and twelve-months post-treatment
Borderline symtom checklist supplement (BSL)	The BSL supplement measures the frequency of eleven self-destructive behaviors. The total score ranges from 0 to 44 where a higher score indicates greater frequency of self-destructive behaviors. Self-rated (adolescent).	Baseline, one-, three- and twelve-months post-treatment
The Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)	The RCADS-25 measures symptoms of depression and anxiety in children and adolescents. This version has 25 items with a total score between 0 and 75, with higher scores indicating greater levels of symptoms. Self-rated (adolescent).	Baseline, one-, three- and twelve-months post-treatment
The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)	The CCNES-A measures parental coping in response to adolescents' negative emotions. The CCNES-A consists of nine hypothetical scenarios accompanied by six types of responses (i.e., emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses). Separate summary scores are calculated per subscale (type of response) and ranges from 1 to 7, with higher scores indicating greater usage of a certain parental coping style. Self-rated (parent).	Baseline, one-, three- and twelve-months post-treatment
The Work and Social Adjustment Scale -Youth version (WSAS-Y)	The WSAS-Y measures functional impairment in school, everyday life, friends and social life, recreation and hobbies, and family and close relationships.This 5-item scale generates a summary score between 0 and 40, with higher scores indicating greater impairment. Youths rate their own impairment. Self-rated.	Baseline, one-, three- and twelve-months post-treatment
The Work and Social Adjustment Scale - Parent version (WSAS-P)	The WSAS-P measures functional impairment in school, everyday life, friends and social life, recreation and hobbies, and family and close relationships.This 5-item scale generates a summary score between 0 and 40, with higher scores indicating greater impairment. Parents rate their youth's impairment. Self-rated.	Baseline, one-, three- and twelve-months post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-rated adherence	Two items asking the participant to rate their own adherence the past week. Self-rated (adolescent).	Treatment week 3
Credibility	Two items asking the participant to rate change in treatment credibility from the previous treatment week. Self-rated (adolescent).	Treatment week 3
Adverse events	A scale were 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-rated (adolescent and parent).	Post-treatment (week 12)
Concomitant treatment	Participants report presence, type, focus, and change an of any potential other concomitant treatment during the trial. Self-rated (adolescent and parent).	Post-treatment (week 12), one- and three-months post-treatment
The clinician's satisfaction with treatment adaptions	Clinicians report their own level of satisfaction with the given treatment adaptions (one item).	Post-treatment (week 12)
Inventory of Statements About Self-injury (ISAS)	ISAS measures frequency, function, age of onset, experience of, and willingness to stop engaging in self-injury. There are 39 items describing common functions of self-injury. Participants are asked to rate if a certain function applies to them, by marking the statement as "Not relevant", "Partly relevant", or "Very relevant". Self-rated (adolescent).	Baseline
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)	The TIC-P measures healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss. Self-rated (parent).	Baseline, one-, three- and twelve-months post-treatment
Academic performance	Grades and eligibility in primary school and upper secondary school, and highest education level. Registry data from the Swedish National Agency for Education and the Swedish longitudinal integrated database for health insurance and labour market studies (LISA).	1-10 years post-treatment
Number of healthcare visits	Registry data from the National Patient Register.	1-10 years post-treatment
Prescription of psychotropics	Registry data from the National Prescribed Drug Register.	1-10 years post-treatment
Mental health disorders	Registered psychiatric disorders. Registry data from the National Patient Register.	1-10 years post-treatment
Reasons for eventual death	Registry data from the National Cause of Death Register.	1-10 years post-treatment
Suicide attempts	Suicide attempts registered by the health care. Registry data from the National Patient Register and Regional Healthcare Registers.	1-10 years post-treatment
Occupation	Occupation, including unemployment and sick leave. Registry data from the Swedish longitudinal integrated database for health insurance and labour market studies (LISA).	1-10 years post-treatment
The Revised Child Anxiety and Depression Scale (RCADS)	The RCADS measures symptoms of depression and anxiety in children and adolescents. RCADS has 47 items with a total score between 0 and 141, with higher scores indicating greater levels of symptoms. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).	1-10 years post-treatment
Children's Global Assessment Scale (CGAS)	The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).	1-10 years post-treatment
Kidscreen-10	The Kidscreen-10 measures quality of life through 10 items. The summary score ranges from 10 to 50 where a higher score indicates greater quality of life. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).	1-10 years post-treatment
Columbia-Suicide Severity Rating Scale (C-SSRS) - 6 item version	The C-SSRS - 6 item version measures the frequency and severity of suicidal ideation and behaviors. Clinician-rated.	Baseline
Columbia-Suicide Severity Rating Scale (C-SSRS)	Two items about suicidal behavior from the C-SSRS are used to measure suicidality during treatment. The items concern preparatory behavior and suicide attempts the past seven days. Self-rated (adolescent).	Week 1 to 12
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)	The DERS-16 measures difficulties in emotion regulation. The total score ranges from 16 to 80, with higher scores indicating greater difficulties. Self-rated (adolescent).	Week 1 to 12
Deliberate Self-harm Inventory - Youth version (DSHI-Y)	The DSHI-Y measures the frequency of the most common NSSI behaviors. Self-rated (adolescent).	Baseline, week one to 12, post-treatment, one-, three- and twelve-months post-treatment
Experiences of self- and assessor-rated nonsuicidal self-injury (NSSI) reports	Adolescents will be asked two questions about the format used to report NSSI: (1) "What was your experience of reporting NSSI in the different formats?", and in case where discrepancies occur between the two reporting formars between: (2) "Which frequency rating do you prefer?". Both questions will be administered by an assessor during a single assessment session.	Baseline, one- or three-months post-treatment
Treatment benefit	Participants are asked to rate, using a single item, the perceived benefit of the intervention-specifically, how much of the knowledge gained continues to help them today. Self-rated (adolescent and parent).	Twelve-months post-treatment

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Vastra Gotaland Region; Region Skane; Region Stockholm
• Investigators: Principal Investigator: Johan Bjureberg, PhD, Karolinska Institutet; Principal Investigator: Olivia Ojala, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adolescence; Self-harm; Internet-delivered treatment; Nonsuicidal self-injury
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Self-Injurious Behavior; Therapeutics
• Other Study ID Numbers: 2024-01916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is pseudonymized in accordance with Swedish and European Union laws and cannot be anonymized and published in an open repository. Study participants have consented to sharing their data with international researchers for meta-analyses. Aggregated data can be provided upon reasonable request on a case-by-case basis in compliance with current legislation and ethical permits

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No