An interventional study of Blended ERITA and Treatment as Usual (TAU) in Nonsuicidal Self Injury, Nonsuicidal Self-Injury and Self-Harm, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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:
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
303 studies on the registry are indexed under Self-Injurious Behavior; 105 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 254 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
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
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
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) will constitute treatment for NSSI according to local clinical guidelines.
Participants are free to receive concomitant care (counselling or medication) in addition to self-injury treatment according to their needs during the trial.
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.
Time frame: One-month post-treatment
Treatment completion
Proportion of adolescents completing ≥ six ERITA modules. Only in the experimental condition. Clinician-rated
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Post-treatment and through study completion, an average of 1 year
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, one-, and three-months post-treatment
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).
Time frame: Baseline
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.
Time frame: Baseline
Care consumption
Degree and type of care consumption as registered by the health care. Registry data from the local Stockholm register for Child and Adolescent Mental Health Services.
Time frame: From enrollment to three-months post-treatment
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).
Time frame: Baseline
Demographical and clinical background data
Current mental health disorders, age, previous and current treatment. Clinician-rated. Gender and sexual orientation. Self-rated (adolescent). Country of birth, living situation, parental occupation, parental academic degree, and parental history of mental health disorders. Self-report (parent)
Time frame: Baseline
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.
Of 161 non-industry interventional studies with no phase under Self-Injurious Behavior, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 53. This study's planned 18 months is below that.
Counting every sponsor, half of 163 studies reached it within 28 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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