Nonsuicidal Self-InjuryNCT07573085
Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services
A study testing Adaptable IERITA, Standard IERITA and Treatment as usual in people with Nonsuicidal Self-Injury and Self-Harm, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Nonsuicidal Self-Injury, Self-Harm
- What is being tested?
- Adaptable IERITA, Standard IERITA and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteSweden
- Study dates
- 22 May 2026to Dec 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 13-17 years old
- At least one self-injury episode in the past three months
- A parent willing to engage in the parent program
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, 113 64
Johan Bjureberg, PhD, +460852480000, johan.bjureberg@ki.se
Johan Bjureberg, PhD
About this 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 optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).
Read the detailed description
Nonsuicidal self-injury (NSSI) 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 NSSI entails risks and suffering.
In this randomized controlled 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, or earlier if the adolescent is at risk of discontinuation, classification of non-remission/remission will be conducted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA (e.g., personalized dose and delivery of treatment) for the remaining weeks (until week 12) while all other participants will continue with standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment, and in public registers up to ten years post-treatment. The primary endpoint is one-month post-treatment.
The primary aim is to evaluate efficacy of an adaptable treatment strategy for adolescents at risk of non-remission. Secondary aims include implementation, cost-effectiveness, moderators and predictors, distal effects, algorithm performance, and psychometrical evaluations. The specific objectives are:
PRIMARY AIM
- Determine the efficacy of adaptable IERITA compared to standard IERITA for adolescents at risk of non-remission at one-month post-treatment (primary endpoint) and to assess the durability of effects at three-month follow-up SECONDARY AIMS
- Determine the cost-effectiveness of adaptable IERITA compared to a standard IERITA.
- Explore the implementation (reach, satisfaction, adherence, level and type of resources, utility) of IERITA in child and adolescent mental health services care.
- Investigate predictors and moderators of treatment outcome.
- Evaluate distal outcomes and long-term effects of adaptable IERITA compared to a standard IERITA.
- Explore the experience of being an IERITA therapist.
- Evaluate the performance of the algorithm predicting treatment non-remission.
- Evaluate the psychometric properties of the Deliberate Self-harm Inventory - Youth version (DSHI-Y).
- Evaluate the agreement between self- and assessor-rated NSSI.
Statistical plan is found at: https://osf.io/6h7fe/overview
This project is sponsored by the Swedish Research Council (number 2024-03122), Fonden för Psykisk Hälsa, Stiftelsen Söderströmska Königska (number SLS-1031985), and Thuring Foundation (2025-186).
- Conditions
- Nonsuicidal Self-Injury, Self-Harm
- Being tested
- Adaptable IERITA, Standard IERITA, Treatment as usual
- Keywords
- Nonsuicidal self-injury, Internet-delivered treatment, Self-harm, Adolescence
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptable IERITABehavioural
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.
Standard IERITABehavioural
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.
Treatment as usualOther
Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard IERITA; Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One-, three- and twelve-months post-treatment
Secondary outcomes (8)
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. 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Baseline, one-, three- and twelve-months post-treatment
Borderline symtom checklist supplement (BSL)
The BSL supplement measures the frequency of self-destructive behaviors. We will measure behaviors of self-harm, suicide attempt, binge eating, self-induced vomiting, high-risk activities, getting drunk, substance use, medication misuse, outbreaks of anger/physical attacks and impulsive/shameful sexual encounters, resulting in a total score between 0 to 40 where a higher score indicates greater frequency of self-destructive behaviors. Self-rated (adolescent).
Measured: 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).
Measured: 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 and adolescent).
Measured: Baseline, one-, three- and twelve-months post-treatment
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).
Measured: Baseline, one-, three- and twelve-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start22 May 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsuicidal Self-InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 341 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Region Skane, Vastra Gotaland Region
- Responsible party
- Principal investigator, Olivia Ojala, Karolinska Institutet
- Investigators
- Johan Bjureberg, PhD, Principal investigator, Karolinska InstitutetOlivia Ojala, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573085
- Sponsor's protocol ID
- 2024-04650-01
- Status last verified
- May 2026
- First submitted
- 25 Apr 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services
- ClinicalTrials.gov ID
- NCT07573085
- Acronym / sponsor ID
- 2024-04650-01
- Conditions
- Nonsuicidal Self-Injury, Self-Harm
- Keywords
- Nonsuicidal self-injury, Internet-delivered treatment, Self-harm, Adolescence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 341 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Region Skane, Vastra Gotaland Region
- Study start
- 22 May 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Nonsuicidal self-injury (NSSI) 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 NSSI entails risks and suffering.
In this randomized controlled 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, or earlier if the adolescent is at risk of discontinuation, classification of non-remission/remission will be conducted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA (e.g., personalized dose and delivery of treatment) for the remaining weeks (until week 12) while all other participants will continue with standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment, and in public registers up to ten years post-treatment. The primary endpoint is one-month post-treatment.
The primary aim is to evaluate efficacy of an adaptable treatment strategy for adolescents at risk of non-remission. Secondary aims include implementation, cost-effectiveness, moderators and predictors, distal effects, algorithm performance, and psychometrical evaluations. The specific objectives are:
PRIMARY AIM
- Determine the efficacy of adaptable IERITA compared to standard IERITA for adolescents at risk of non-remission at one-month post-treatment (primary endpoint) and to assess the durability of effects at three-month follow-up SECONDARY AIMS
- Determine the cost-effectiveness of adaptable IERITA compared to a standard IERITA.
- Explore the implementation (reach, satisfaction, adherence, level and type of resources, utility) of IERITA in child and adolescent mental health services care.
- Investigate predictors and moderators of treatment outcome.
- Evaluate distal outcomes and long-term effects of adaptable IERITA compared to a standard IERITA.
- Explore the experience of being an IERITA therapist.
- Evaluate the performance of the algorithm predicting treatment non-remission.
- Evaluate the psychometric properties of the Deliberate Self-harm Inventory - Youth version (DSHI-Y).
- Evaluate the agreement between self- and assessor-rated NSSI.
Statistical plan is found at: https://osf.io/6h7fe/overview
This project is sponsored by the Swedish Research Council (number 2024-03122), Fonden för Psykisk Hälsa, Stiftelsen Söderströmska Königska (number SLS-1031985), and Thuring Foundation (2025-186).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual | Experimental | Behavioral: Adaptable IERITA, Other: Treatment as usualParticipants 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. |
| Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual | Active comparator | Behavioral: Standard IERITA, Other: Treatment as usualParticipants 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 13-17 years old
- At least one self-injury episode in the past three months
- A parent willing to engage in the parent program
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptable IERITAIERITA 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. | Behavioural | Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual |
| Standard IERITAIERITA 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. | Behavioural | Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual |
| Treatment as usualParticipants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial. | Other | Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual, Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual |
Primary outcome
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
Time frame: One-, three- and twelve-months post-treatment
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.
8 secondary outcomes
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
Time frame: Baseline, one-, three- and twelve-months post-treatment
Children's Global Assessment Scale (CGAS)
Time frame: Baseline, one-, three- and twelve-months post-treatment
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Time frame: Baseline, one-, three- and twelve-months post-treatment
Child Health Utility 9D (CHU-9D)
Time frame: Baseline, one-, three- and twelve-months post-treatment
Borderline symtom checklist supplement (BSL)
Time frame: Baseline, one-, three- and twelve-months post-treatment
The Revised Child Anxiety and Depression Scale-Short Version (RCADS-25)
Time frame: Baseline, one-, three- and twelve-months post-treatment
The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
Time frame: Baseline, one-, three- and twelve-months post-treatment
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
Time frame: Baseline, one-, three- and twelve-months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johan Bjureberg, PhD principal investigator
Karolinska Institutet
Olivia Ojala, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptable IERITA, Standard IERITA and Treatment as usual in people with Nonsuicidal Self-Injury and Self-Harm, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Ojala, PhD (+46761426565, olivia.ojala@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deliberate Self-harm Inventory - Youth version (DSHI-Y) (time frame: One-, three- and twelve-months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.