Nonsuicidal Self InjuryNCT07755774
Psychological Treatment for Adolescents With Self-injury Within Intensive Mental Health Outpatient Services: Randomized Controlled Pilot Trial
A study testing Blended ERITA, Treatment as Usual (TAU) and Concomitant care in people with Nonsuicidal Self Injury and Nonsuicidal Self-Injury, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Nonsuicidal Self Injury, Nonsuicidal Self-Injury, Self-Harm
- What is being tested?
- Blended ERITA, Treatment as Usual (TAU) and Concomitant care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2026to Jun 2028
- Phase
- Interventional
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12-17 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)
Who cannot join
- 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
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
Samantha Khoo, +4602355460, samantha.khoo@ki.se
Olivia Ojala, PhD
About this study
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.
Read the detailed description
NSSI is a growing health crisis among youth and the strongest risk factor for suicide attempts. Scalable and evidence-based treatments are needed but lacking. We have recently shown that a brief digital treatment, Internet-delivered ERITA, can be efficacious compared to treatment as usual only.
However, digital treatment is not suitable for everyone. Adolescents with low levels of functioning have trouble engaging in text-based therapy independently from home. A blended format, which combines in-person and online treatment, may enhance effectiveness; therapists can tailor delivery of material, and adolescents can access the skills when necessary.
This project aims to develop and evaluate a blended version of ERITA - blended ERITA - for adolescents with low levels of functioning. The specific objectives of this pilot study are:
Primary:
- Evaluate the feasibility of the project (i.e., data proportion at the primary endpoint, adherence, treatment completion, and therapist time)
- Evaluate acceptability of blended ERITA (i.e., satisfaction, credibility, negative effects)
Secondary:
- Provide explorative data on the utility of blended ERITA and treatment as usual.
This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2025-01507).
The protocol including statistical analysis plan is found at: https://osf.io/e6wjq/overview
- Conditions
- Nonsuicidal Self Injury, Nonsuicidal Self-Injury, Self-Harm
- Being tested
- Blended ERITA, Treatment as Usual (TAU), Concomitant care
- Keywords
- Nonsuicidal self-injury, Self-harm, Psychological treatment, 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.
Blended ERITABehavioural
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.
Treatment as Usual (TAU)Behavioural
Treatment as usual (TAU) will constitute treatment for NSSI according to local clinical guidelines.
Concomitant careOther
Participants are free to receive concomitant care (counselling or medication) in addition to self-injury treatment according to their needs during the trial.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual (TAU); Other: Concomitant care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One-month post-treatment
Treatment completion
Proportion of adolescents completing ≥ six ERITA modules. Only in the experimental condition. Clinician-rated
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Post-treatment and through study completion, an average of 1 year
Secondary outcomes (10)
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
The DSHI-Y is a youth-adaptation of the DSHI and measures the six most common NSSI methods. The primary clinical outcome will be the proportion of treatment remission. Remission will be defined as the absence of NSSI in the past month and measured dichotomously (yes/no). The primary data source will be blinded assessor-rated DSHI-Y. If these data are missing, self-reported DSHI-Y will be used.
Measured: One- and three-months post-treatment
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-, and three-months post-treatment
Difficulties in Emotion Regulation Scale - 16 items 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-, and three-months post-treatment
Clinical 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-, and three-months post-treatment
Borderline Symptom List - Behavior Supplement (BSL-Supplement)
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-, and three-months post-treatment
Child Health Utility 9D Index (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-, and three-months post-treatment
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-, and three-months post-treatment
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-, and three-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.
Measured: Baseline, one-, and three-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.
Measured: Baseline, one-, and three-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 posted10 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Olivia Ojala, Karolinska Institutet
- Investigators
- Olivia Ojala, PhD, Principal investigator, Karolinska InstitutetJohan Bjureberg, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755774
- Sponsor's protocol ID
- 2025-01507
- Other IDs
- 2025
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 21 Sep 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.