An interventional study of Emotion Regulation Individual Therapy for Adolescents (ERITA) and Treatment as usual in Self-Injurious Behavior, sponsored by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital. Active, not recruiting at 4 sites in Denmark. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Not applicable, Interventional, and Treatment
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Emotion Regulation Individual Therapy for Adolescents, also called ERITA, is a youth friendly online therapy aiming to provide skills and train emotion regulation.
The aim of the TEENS Multi-site Trial is to investigate the effect of ERITA, including an app, as add-on to treatment as usual in young patients referred to Mental Health Services. We expect 356 families to participate from three designated Regions in Denmark.
Background: A prevalence of non-suicidal self-injury is not easily assessed; however, meta-analyses found a lifetime prevalence of 17% in non-clinical student samples. This estimate increases to 50-74% in psychiatric populations. Non-suicidal self-injury is an important predictor for later suicidal behavior and death by suicide. Although non-suicidal self-injury is highly prevalent, there is no evidence for specific treatment for non-suicidal self-injury in adolescents. Reviews find that internet-based interventions guided by a therapist are effective for several psychiatric disorders such as anxiety and depression in adult population. Patients with stigmatizing illnesses such as non-suicidal self-injury may be reluctant to seek help and adhere with treatment while internet-based interventions are more appealing. There is a need for trials investigating the effect of specialized interventions for non-suicidal self-injury in youth, including digital interventions.
Objective: To investigate the effect of an internet-based intervention, Emotion Regulation Individual Therapy for Adolescents (ERITA), as add-on to treatment as usual in 13-17-year-old patients with non-suicidal self-injury referred to Child- and Adolescent Mental Health Services with subsequent non-suicidal self-injury as primary outcome assessed by Deliberate Self-Harm Inventory - Youth. Further clinical outcomes such as quality of life, depression, anxiety and stress, as well as emotion regulation difficulties will be assessed as secondary outcomes.
Method and materials: This is a randomized, clinical, superiority, multicenter trial in a parallel group design. Patients will be recruited from Child- and Adolescent Mental Health Services in three of the Danish Regions: The trial inclusion period will be from primo 2022 to ultimo 2023. The experimental intervention is therapist guided internet-based ERITA provided exclusively online as add-on to treatment as usual in the experimental group. Treatment as usual is provided by multidisciplinary teams in outpatient clinics in all participating regions. We expect to include 356 participants and one of their parents.
303 studies on the registry are indexed under Self-Injurious Behavior; 105 are open to participants now.
This study's enrollment of 363 is above the median of 70 across 254 interventional studies indexed under Self-Injurious Behavior.
Browse Self-Injurious Behavior studies →Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Emotion Regulation Individual Therapy for Adolescents (ERITA) intervention as add-on to TAU consists of 11 weeks, manualized online therapy based on the methods of Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT) adapted for youth
Behavioral: Emotion Regulation Individual Therapy for Adolescents (ERITA) · Other: Treatment as usual
Within mental health services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this study the control intervention (TAU) consists of clinical assessment and treatment for patient's current primary psychiatric condition (referral condition and A-diagnosis).
Other: Treatment as usual
The ERITA intervention as add-on to TAU consists of 11 weeks, manualized online therapy based on the methods of Cognitive Behavioral Therapy (CBT), Dialectical Behavior Therapy (DBT), and Acceptance and Commitment Therapy (ACT) adapted for youth. The ERITA content consists of psychoeducation, emotion recognition, awareness training and theory of emotion regulation, including acceptance and validation skills.
Also known as: ERITA
Within Mental Health Services in Denmark child and adolescent psychiatrists provide specialized treatment for young psychiatric patients as outpatient services. In this trial the control intervention is treatment as usual (TAU) and consists of clinical assessment and treatment for patient's current primary psychiatric condition. TAU encounters a variety of clinical treatment and assessment offers, however, all within the field of expertise in child and adolescent psychiatry; out-patient care may consist of treatment for OCD, eating disorders, psychoses or affective disorders. TAU may consist of pharmacological treatment, Family-Based Treatment (FBT), Cognitive Behavioral Therapy (CBT), supportive counselling and/or psychoeducation.
Non-suicidal self-injury episodes
Non-suicidal self-injury within the last four weeks, at end of intervention (12 weeks) by blinded outcome assessment by phone or video conference measured by Deliberate Self-Harm Inventory
Time frame: End of treatment after 12 weeks and 6 months follow-up
Kidscreen-10; Quality of life
Quality of life at 12 weeks, assessed with Kidscreen-10, a five point likert scale, range: not at all, a little, moderate, much, very much.
Time frame: End of treatment after 12 weeks and 6 months follow-up
Symptoms of depression, anxiety and stress
Symptoms of depression, anxiety and stress at 12 weeks, assessed with Depression Anxiety Stress Scale (DASS-21) presented as analyses for each subgroup item. Four point likert scale, range: did not apply to me, applied to me to some degree, applied to me to a considerable degree, applied to me much/most of the time. Total rage for subscores: 0-42. Higher scores reflect worse outcome.
Time frame: End of treatment after 12 weeks and 6 months follow-up
Non-suicidal self-injury as dichotomous (any/none)
The proportion of participants with any NSSI during the past four weeks.
Time frame: End of treatment after 12 weeks and 6 months follow-up
Difficulties in emotion regulation
Difficulties in emotion regulation, assessed with Difficulties in Emotion Regulation Scale - 16 Item Version (DERS-16). DERS-16 has 16 items which each generates a score from 1 to 5. The results will be presented as one sum-score. The scores in this scale range from 16-80 with higher scores indicating greater emotion regulation difficulties.
Time frame: End of treatment after 12 weeks and 6 months follow-up
Borderline Symptom List (BSL-supplement).
Indirect self-destructive behaviours assessed with Borderline Symptom List (BSL-supplement). BSL-supplement has 11 items which each generates a score from 0 to 4. The results will be presented as one sum-score.
Time frame: Through trial periode (every three weeks, end of treatment after 12 weeks and 6 months follow-up)
Suicidal ideations
Suicidal ideations assessed by SIDAS. A five item scale with questions ranging from 0 to 10. Final sum score from 0-50.
Time frame: Through trial period (every three weeks, end of treatment after 12 weeks and 6 months follow-up)
Coping with Children's Negative Emotions - Adolescents
Adolescent rated parents' ability to cope with children's negative emotions assessed with The Coping with Children's Negative Emotions Scale (CCNES-APP). 9 main items with 6 sub items (a to f) for each. Each sub item generates a score from 1 to 7. The results will be presented as mean-scores for the six subscales.
Time frame: End of treatment after 12 weeks and 6 months follow-up
Coping with Children's Negative Emotions - Parents
Parent-rated perceived ability to cope with children's negative emotions assessed with The Coping with Children's Negative Emotions Scale Adolescent (CCNES-A). 9 main items with 6 sub items (a to f) for each. Each sub item generates a score from 1 to 7. The results will be presented as mean-scores for the six subscales.
Time frame: End of treatment after 12 weeks and 6 months follow-up
Negative Effects Questionnaire
Adverse Events of therapy assessed with Negative Effects Questionnaire (NEQ). NEQ has 20 items, with 5 sub-items The results will be presented as means and standard deviations.
Time frame: Through trial periode (every three weeks and end of treatment after 12 weeks)
Working Alliance
The alliance percieved between the participant and the therapist, WAI-SR
Time frame: Through the trial period (week four and eight)
Started Feb 2022 (actual). Primary completion is estimated for Apr 2027, 62 months after the start.
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 62 months is above that.
Counting every sponsor, half of 163 studies reached it within 28 months; a quarter within 15 and three quarters within 52.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 9, 2026: primary completion May 2026 → Apr 2027 and completion Dec 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital