TEENS Multi-site Trial

NCT05179655 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2025-03-10

No results posted yet for this study

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.

Conditions

  • Self-Injurious Behavior

Interventions

BEHAVIORAL

Emotion Regulation Individual Therapy for Adolescents (ERITA)

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.

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 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.

Sponsors & Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER
  • Region of Southern Denmark

    collaborator OTHER
  • Region Zealand

    collaborator OTHER
  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Anne K Pagsberg, Professor · Mental Health Services Capital Region Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2026-05-15
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05179655 on ClinicalTrials.gov