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Recruiting NCT05179655

NCT05179655 TEENS Multi-site Trial

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Clinical Trial Summary
NCT ID NCT05179655
Status Recruiting
Phase
Sponsor Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Condition Self-Injurious Behavior
Study Type INTERVENTIONAL
Enrollment 356 participants
Start Date 2022-02-01
Primary Completion 2026-05-15

Eligibility & Interventions

Sex All sexes
Min Age 13 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
Emotion Regulation Individual Therapy for Adolescents (ERITA)Treatment as usual

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 356 participants in total. It began in 2022-02-01 with a primary completion date of 2026-05-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * ≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month assessed by the Deliberate Self-Harm Inventory, Youth version (DSHI-Y). * Age-appropriate literacy assessed by referring clinicians and the self-injury team, i.e. age between 13 and 17. * Having at least one parent committing to participate in the parent program. * Informed consent from parents/legal caretakers and assent from participants above 15 years of age. Exclusion Criteria: * Imminent suicidal risk assessed by clinicians during routine screening procedure (that can be rated as no risk, elevated risk, or imminent risk) in need of admission or other life saving strategies. * Lack of informed consent from parents/legal caretakers. * Lack of informed assent from the participant above 15 years of age.

Contact & Investigator

Central Contact

Britt Morthorst

✉ britt.reuter.morthorst@regionh.dk

📞 0045 27521085

Principal Investigator

Anne K Pagsberg, Professor

STUDY CHAIR

Mental Health Services Capital Region Denmark

Frequently Asked Questions

Who can join the NCT05179655 clinical trial?

This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Self-Injurious Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05179655 currently recruiting?

Yes, NCT05179655 is actively recruiting participants. Contact the research team at britt.reuter.morthorst@regionh.dk for enrollment information.

Where is the NCT05179655 trial being conducted?

This trial is being conducted at Aalborg, Denmark, Odense, Denmark, Roskilde, Denmark, Copenhagen, Denmark.

Who is sponsoring the NCT05179655 clinical trial?

NCT05179655 is sponsored by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital. The principal investigator is Anne K Pagsberg, Professor at Mental Health Services Capital Region Denmark. The trial plans to enroll 356 participants.

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