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Rigshospitalet - en del af Københavns Universitetshospital

TEENS Feasibility trial: Treatment Effects of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) added to Treatment as Usual in Young People with Non-Suicidal Self-Injury

Projekt: Typer af projekterProjekt

  • Morthorst, Britt Reuter (Projektleder, faglig)
  • Jakobsen, Janus Christian (Projektdeltager)
  • Pagsberg, Anne Katrine (Projektleder, faglig)
  • Rubæk, Lotte (Projektdeltager)
  • Jørgensen, Ida Lichtenstein (Projektdeltager)
  • Holm, Christian (Projektdeltager)
  • Semmling, Cecilie Krag (Projektdeltager)
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Intro:
Non-suicidal self-injury has disseminated almost epidemically through the last decades, with a lifetime prevalence in non-clinical samples of approximately 17% among adolescents; increasing to 50-75% in psychiatric populations. The definition of non-suicidal self-injury excludes self-injury with suicidal intent, but though there is a difference in etiology, non-suicidal self-injury is the most important predictor of later suicidal behavior. No treatment for non-suicidal self-injury in adolescents, when analyzed separately from suicide attempts, is superior to treatment as usual. Therefore, there is a need for randomized controlled trials testing specific treatments for non-suicidal self-injury. Reviews have shown that internet-based interventions guided by a therapist are effective for several psychiatric disorders. It has been argued that patients with stigmatizing illnesses such as non-suicidal self-injury tend to be reluctant to seek help and adhere with treatment while internet-based interventions are more accepted. The objectives are to assess the feasibility of methods, procedures, and safety of internet-based ERITA added to treatment as usual (TAU) in 13-17-year-old patients with non-suicidal self-injury referred to psychiatric services.

Methods:
A feasibility trial including a randomization procedure in a parallel group design. We investigate the feasibility of internet-based intervention as add-on to treatment as usual (TAU) compared to TAU alone in NSSI engaging youth referred to psychiatric outpatients services in the capital Region of Denmark. We wish to include a pragmatic population of patients with a variety of diagnoses since all may present with comorbidity of NSSI. The experimental intervention consists of online Emotion Regulation Individual Therapy for Adolescents (ERITA) which is provided as add-on to TAU and compared to TAU alone. The treatment responsibility and safety measures are anchored in the provision of TAU. The feasibility outcomes investigated are: follow-up rate (completion rate), inclusion rate (eligible patients randomized), and compliance rate followed by explorative clinical outcomes.

Results (expected):
The primary hypotheses regarding feasibility are 1) We expect ≥ 87% to complete follow-up questionnaires (data completion fraction at end of intervention). 2) We expect ≥ 40% of eligible patients and parents to be included by given informed consent and proceed to randomisation. 3) We expect ≥ 73% of the participants will comply with experimental intervention and complete at least six modules out of 12 modules. 4) We expect ≥ 73% of the participants’ parents will comply with experimental intervention and complete at least three out of six modules.

Discussion/impact (expected):
This feasibility trial will provide information to design and align a large-scale trial investigating the effect of internet-based intervention for adolescents engaging in NSSI. ERITA like other internet-based therapies has the potential to increase accessibility to evidence-based treatments by eliminating the barriers of geographical distances between patients and providers. If the experimental intervention is proven effective, then this may be considered implemented both regionally and nationally in Denmark.

StatusIgangværende
Periode02/02/202031/12/2029

    Forskningsområder

  • Sundhedsvidenskab - Psychotherapy, Psychosocial Interventions, Randomized Controlled Clinical Trial

ID: 61842698