Effects of Internet-based ERITA Added to TAU in Young People With Non-Suicidal Self-Injury (TEENS) Feasibility Trial

Mental Health Services in the Capital Region, Denmark

Status: Completed

Conditions: Non-suicidal Self-injury

Treatments: Behavioral: Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)

Study type: Interventional

Funder types: Other

Identifiers

NCT04243603

H-19042904

Details and patient eligibility

About

There has been a significant increase in non-suicidal self-injury the last decades especially among young people and treatment initiative are sparse. We aim to assess the feasibility of methods, procedures, and safety of internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as add on to treatment as usual (TAU) in 13-17-year-old patients with non-suicidal self-injury referred to psychiatric services.

Full description

Non-suicidal self-injury has disseminated almost epidemically through the last decades in young persons. There is no evidence of any experimental treatment for non-suicidal self-injury in adolescents, superior to treatment as usual. Patients with stigmatizing illness such as non-suicidal self-injury may find internet-based interventions more acceptable. The study is a feasibility trial, with a randomization procedure in a parallel group design. Patients will be recruited from Child- and Adolescent Mental Health Services (age 13 to 17 years). The experimental intervention is internet-based, and therapist guided; ERITA consists of online Emotion Regulation Individual Therapy for Adolescents (ERITA) as add-on to treatment as usual. Treatment as usual is provided by multidisciplinary teams in nine outpatient clinics within Child and Adolescent Mental Health Services in the Capital Region of Denmark. Feasibility of recruitment and trial procedures will be monitored as well as explorative clinical outcomes.

Enrollment: 30 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month (DSM-5 criteria for a diagnosis of non-suicidal self-injury disorder in terms of frequency of NSSI).
• Age-appropriate literacy.
• Having at least one parent committing to participate in the parent program.
• Informed consent from parents/legal caretakers.

Exclusion criteria

• Imminent suicidal risk assessed by clinicians during routine screening procedure (rated as no risk, elevated risk, imminent risk) in need of admission or other life saving strategies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Internet-based ERITA-DK

Experimental group

Description:

ERITA is a youth-adapted version of Emotion Regulation Group Therapy (ERGT), based on cognitive behavioral therapy (CBT), dialectical behavior therapy (DBT), and Acceptance and Commitment Therapy (ACT), which encounters emotional recognition and regulation, crisis strategies and skills training. The ERITA intervention is provided as add-on to TAU and consists of 12 weeks, manualized, therapist guided internet-based therapy. The intervention also provides six modules for the parents focusing on NSSI and other risk-taking behaviors, emotional awareness, and validation skills. The participants must complete one module every week while the parents must complete a module every second week. A mobile app is available to complement the online treatment. The app includes reminders of homework and skills and allows to report on both self-destructive behaviors and impulses daily.

Treatment:

Behavioral: Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)

Treatment as Usual (TAU)

Active Comparator group

Description:

Child and Adolescent Mental Health Services (CAMHS) offer specialized treatment for children and adolescents. TAU encounters a variety of clinical treatment and assessment offers, representing a highly inhomogeneous group of treatments, for instance: Pharmacological treatment, Family-Based Treatment (FBT), Cognitive Behavioral Therapy, supportive counselling and psychoeducation. Throughout the trial course the treatment responsibility is handled by clinicians providing TAU.

Treatment:

Behavioral: Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)