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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Non-suicidal self-injury as explorative primary clinical outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, a blinding of participants and therapists (intervention providers) is not possible. Blinded outcome assessment and data management will be performed. Statistical analyses will be performed by two blinded statisticians presenting independent reports. Based on the two blinded conclusions, two abstracts will be written and published (on a website).
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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.
排除标准
- •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.
结局指标
主要结局
Non-suicidal self-injury as explorative primary clinical outcome
时间窗: End of treatment at 12 weeks
Non-suicidal self-injury, assessed at baseline and end of therapy (12 weeks) by blinded outcome assessment by phone with Deliberate Self-Harm Inventory (DSHI-Y)
Completion of follow-up
时间窗: End of treatment at 12 weeks
Completion of follow-up will be defined as completing at least one clinical outcome (non-suicidal self-injury events) at end of intervention. If the number participants with completed outcomes is 26 out of 30, the fraction will be 87%, 95% CI 75% to 99%. A follow-up fraction of 87% or more will be acceptable for a future trial while a fraction below 75% will impose serious problems of interpreting the trial result in a future large pragmatic trial.
Compliance
时间窗: End of treatment at 12 weeks
Compliance with the experimental intervention will be defined as completing at least six of 12 ERITA sessions. ERITA will automatically register time for login and save the exercises that have been completed. If the number of compliant experimental participants is 11 out of 15, the fraction will be 73%, 95% CI 51% to 96%. A compliance fraction of 51% or more will be acceptable for a future trial while a fraction below 51% will impose serious problems of interpreting the trial result in a future large pragmatic trial.
The fraction of eligible participants who consent to inclusion and randomization
时间窗: End of treatment at 12 weeks
We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons. If the number of participants randomized out of the number of eligible persons is 30 out of 75, the fraction will be 40%, 95% confidence interval (CI) will be: 29% to 51%. A randomization fraction of 29% or more will be acceptable for a future trial, while a fraction below 29% will impose serious problems of recruitment for a future large pragmatic trial.
次要结局
- Symptoms of depression, anxiety and stress as explorative secondary clinical outcomes(End of treatment at 12 weeks)
- Non-suicidal self-injury as dichotomous variables as explorative secondary clinical outcome(End of treatment at 12 weeks)
- Number of sick days the last month as explorative secondary clinical outcome(End of treatment at 12 weeks)
- Quality of life as explorative secondary clinical outcomes(End of treatment at 12 weeks)
研究者
Britt Reuter Morthorst
Principal investigator
Mental Health Services in the Capital Region, Denmark