Britt Morthorst1, Lotte Rubæk2, Jane Lindschou3, Janus Christian Jakobsen3,4, Christian Gluud3, Johan Bjureberg5, Clara Hellner5, Bo Møhl6, Anne Katrine Pagsberg7. 1. Research Unit, Child and Adolescent Mental Health Services, The Capital Region of Denmark, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark. britt.reuter.morthorst@regionh.dk. 2. Team of Self-Injury, Child and Adolescent Mental Health Services, The Capital Region of Denmark, Lersøpark allé 107, 2100, Copenhagen Ø, Denmark. 3. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark. 4. Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. 5. Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, Stockholms läns sjukvårdsområde (SLSO), Sachsgatan 10, 118 61, Stockholm, Sweden. 6. Department of Communication and Psychology, Aalborg University, Teglgårds Plads 1 (Nordkraft), 9200, Aalborg, Denmark. 7. Research Unit, Child and Adolescent Mental Health Services, The Capital Region of Denmark, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.
Abstract
BACKGROUND: Non-suicidal self-injury (NSSI) has gained increased attention in recent years due to increased prevalence, especially among adolescents. Evidence-based interventions for NSSI are sparse. Emotion regulation individual therapy for adolescents (ERITA) is an online intervention that needs investigation. Non-randomised studies suggest ERITA improves emotion regulations skills and reduces NSSI frequency. Before conducting a large pragmatic randomised clinical trial, we aim to investigate the feasibility of ERITA in Denmark. METHODS: A randomised, parallel group feasibility trial comparing ERITA as add on to treatment as usual versus treatment as usual in 30 adolescents age 13-17 years with recurrent NSSI referred to outpatient clinics in The Child and Adolescent Mental Health Services in the Capital Region of Denmark. Feasibility outcomes are (1) completion of follow-up, (2) the fraction of eligible participants who consent to inclusion and randomisation and (3) compliance with the intervention. Clinical outcomes such as self-injury frequency and the ability to regulate emotions will be investigated exploratorily. DISCUSSION: Internet-based interventions are assumed to be appealing to adolescents by being easily accessible and easy to navigate by tech natives. Disclosure of self-injury behaviour may be facilitated by an online intervention. The evidence for self-injury specific treatment needs to be extended but prior to a large clinical trial, the feasibility of methods and procedures must be assessed. TRIAL REGISTRATION: ClinicalTrials.Gov Identifier: NCT04243603 .
RCT Entities:
BACKGROUND: Non-suicidal self-injury (NSSI) has gained increased attention in recent years due to increased prevalence, especially among adolescents. Evidence-based interventions for NSSI are sparse. Emotion regulation individual therapy for adolescents (ERITA) is an online intervention that needs investigation. Non-randomised studies suggest ERITA improves emotion regulations skills and reduces NSSI frequency. Before conducting a large pragmatic randomised clinical trial, we aim to investigate the feasibility of ERITA in Denmark. METHODS: A randomised, parallel group feasibility trial comparing ERITA as add on to treatment as usual versus treatment as usual in 30 adolescents age 13-17 years with recurrent NSSI referred to outpatient clinics in The Child and Adolescent Mental Health Services in the Capital Region of Denmark. Feasibility outcomes are (1) completion of follow-up, (2) the fraction of eligible participants who consent to inclusion and randomisation and (3) compliance with the intervention. Clinical outcomes such as self-injury frequency and the ability to regulate emotions will be investigated exploratorily. DISCUSSION: Internet-based interventions are assumed to be appealing to adolescents by being easily accessible and easy to navigate by tech natives. Disclosure of self-injury behaviour may be facilitated by an online intervention. The evidence for self-injury specific treatment needs to be extended but prior to a large clinical trial, the feasibility of methods and procedures must be assessed. TRIAL REGISTRATION: ClinicalTrials.Gov Identifier: NCT04243603 .
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