Clinical trial NCT04243603: Effects of Internet-based ERITA Added to TAU in Young People With Non-Suicidal Self-Injury (TEENS) Feasibility Trial
Official title: 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 - (TEENS) Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-suicidal Self-injury
Keywords: Non-suicidal Self-injury
Internet-based intervention
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Karolinska Institutet
First posted: 2020-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, feasibility trial including a randomization procedure in a parallel group design with blinded outcome assessment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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 (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.

Primary outcomes:
measure: Completion of follow-up
timeFrame: End of treatment at 12 weeks
measure: The fraction of eligible participants who consent to inclusion and randomization
timeFrame: End of treatment at 12 weeks
measure: Compliance
timeFrame: End of treatment at 12 weeks
measure: Non-suicidal self-injury as explorative primary clinical outcome
timeFrame: End of treatment at 12 weeks
Secondary outcomes:
measure: Quality of life as explorative secondary clinical outcomes
timeFrame: End of treatment at 12 weeks
measure: Symptoms of depression, anxiety and stress as explorative secondary clinical outcomes
timeFrame: End of treatment at 12 weeks
measure: Non-suicidal self-injury as dichotomous variables as explorative secondary clinical outcome
timeFrame: End of treatment at 12 weeks
measure: Number of sick days the last month as explorative secondary clinical outcome
timeFrame: End of treatment at 12 weeks
Other outcomes:
measure: Difficulties in emotion regulation as further explorative clinical outcome
timeFrame: At end of treatment and once a week for 12 weeks
measure: Indirect self-destructive behaviours as further explorative clinical outcome
timeFrame: End of treatment at 12 weeks
measure: Suicidal ideations, plans and actions as further explorative clinical outcome
timeFrame: End of treatment at 12 weeks
measure: Parents' ability to cope with children's negative emotions as further explorative clinical outcome
timeFrame: After week six and week 12
measure: Parents' perceived ability to cope with children's negative emotions as further explorative clinical outcome
timeFrame: After week six and week 12
measure: Adverse Events as further explorative clinical outcome
timeFrame: After week 4, 8, and 12
measure: Strengths and difficulties as further explorative clinical outcome
timeFrame: After week 4, 8, and 12
measure: Working alliance with online therapist as further explorative clinical outcome
timeFrame: After week 4, 8, and 12
Locations:
city: Copenhagen
country: Denmark
facility: Team for Self-injury, Child and Adolescent Mental Health Services, B195
Study officials:
affiliation: Child & Adolescent Mental Health Services Capital Region of Denmark
name: Anne Katrine Pagsberg, Professor
role: STUDY_DIRECTOR
References:
citation: Olsen MH, Morthorst B, Pagsberg AK, Heinrichsen M, Mohl B, Rubaek L, Bjureberg J, Simonsson O, Lindschou J, Gluud C, Jakobsen JC. An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial. Trials. 2021 Jul 16;22(1):456. doi: 10.1186/s13063-021-05406-2.
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
citation: Morthorst B, Rubaek L, Lindschou J, Jakobsen JC, Gluud C, Bjureberg J, Hellner C, Mohl B, Pagsberg AK. An internet-based emotion regulation intervention versus no intervention for nonsuicidal self-injury in adolescents: study protocol for a feasibility trial. Pilot Feasibility Stud. 2021 Feb 6;7(1):44. doi: 10.1186/s40814-021-00785-4.