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Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services

2026年6月5日 更新者：Olivia Ojala、Karolinska Institutet
The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Nonsuicidal self-injury (NSSI) is a growing and urgent global health crisis among youth. It is associated with substantial individual and societal costs, including increased risk of suicide attempts. Scalable and evidence-based treatments are needed but lacking. Digital interventions can be one promising solution. A recent study shows that a novel brief digital treatment, IERITA, can be efficacious compared to treatment as usual only. However, not all respond sufficiently to standardized treatment, such as IERITA, and continued NSSI entails risks and suffering.

In this randomized controlled trial, participants will be randomly allocated (1:1) to standard IERITA or adaptable IERITA. All participants will first receive standard IERITA for four weeks. In treatment week four, or earlier if the adolescent is at risk of discontinuation, classification of non-remission/remission will be conducted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA (e.g., personalized dose and delivery of treatment) for the remaining weeks (until week 12) while all other participants will continue with standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment, and in public registers up to ten years post-treatment. The primary endpoint is one-month post-treatment.

The primary aim is to evaluate efficacy of an adaptable treatment strategy for adolescents at risk of non-remission. Secondary aims include implementation, cost-effectiveness, moderators and predictors, distal effects, algorithm performance, and psychometrical evaluations. The specific objectives are:

PRIMARY AIM

  1. Determine the efficacy of adaptable IERITA compared to standard IERITA for adolescents at risk of non-remission at one-month post-treatment (primary endpoint) and to assess the durability of effects at three-month follow-up

    SECONDARY AIMS

  2. Determine the cost-effectiveness of adaptable IERITA compared to a standard IERITA.
  3. Explore the implementation (reach, satisfaction, adherence, level and type of resources, utility) of IERITA in child and adolescent mental health services care.
  4. Investigate predictors and moderators of treatment outcome.
  5. Evaluate distal outcomes and long-term effects of adaptable IERITA compared to a standard IERITA.
  6. Explore the experience of being an IERITA therapist.
  7. Evaluate the performance of the algorithm predicting treatment non-remission.
  8. Evaluate the psychometric properties of the Deliberate Self-harm Inventory - Youth version (DSHI-Y).
  9. Evaluate the agreement between self- and assessor-rated NSSI.

Statistical plan is found at: https://osf.io/6h7fe/overview

This project is sponsored by the Swedish Research Council (number 2024-03122), Fonden för Psykisk Hälsa, Stiftelsen Söderströmska Königska (number SLS-1031985), and Thuring Foundation (2025-186).

研究类型

介入性

注册 (估计的)

341

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 瑞典
      • Stockholm、瑞典、113 64
        • 招聘中
        • Karolinska Institutet
        • 接触：
        • 首席研究员：
          • Johan Bjureberg, PhD
        • 副研究员：
          • Olivia Ojala, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • 13-17 years old
  • At least one self-injury episode in the past three months
  • A parent willing to engage in the parent program

Exclusion Criteria:

  • Immediate suicide risk
  • Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS)
  • Social problems needing immediate intervention (e.g., violence within the family)
  • Ongoing dialectical behavior therapy for adolescents

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：标准的互联网传递情绪调节个人治疗的辅助治疗
参与者将在12周内接受互联网传递的情绪调节个人疗法（IERITA）。 所有参与者将在整个治疗期间继续标准IERITA。 除了IERITA，参与者还可以按照社区提供的12周照射接受任何类型的治疗。
其他：照常治疗
参与者可以根据需要在试验期间根据需要免费接受任何定期护理（即，心理社会治疗，药物或两者的组合）。
行为的：标准IERITA
IERITA是一种基于12周的接受行为疗法。 目的是通过学习和使用其他方式来调节情绪来减少自我伤害。 IERITA包括参与者可以阅读文本，观看视频，收听音频并给他们分配的治疗师发送消息的模块。 青少年治疗是11个模块，父课程为6个。 青少年和父母都获得了单独的异步在线治疗师的支持。
实验性的：Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usual
Participants will receive Internet-delivered Emotion Regulation Individual Therapy (IERITA) for 12 weeks. Adolescents allocated to experimental arm and classified as likely non-remission, will change to adapted IERITA in treatment week four (or earlier if the adolescent is at risk of discontinuation). Adolescents allocated to experimental arm and classified as likely remission will continue standard IERITA. In addition to IERITA, participants are free to will receive any type of treatment as usual for 12 weeks as provided in the community.
其他：照常治疗
参与者可以根据需要在试验期间根据需要免费接受任何定期护理（即，心理社会治疗，药物或两者的组合）。
行为的：Adaptable IERITA

IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support.

In the adapted IERITA intervention, the therapists develop an individual case conceptualization that forms the basis for a brief interview with the adolescent after the classification phase (from randomization to treatment week four), during which potential obstacles and necessary adaptations are explored. Adaption can entail scheduled or regular chats or videoconferences, selecting specific material to focus on, and involving additional support persons. The adapted IERITA intervention is offered after the classification phase until treatment week 12.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
大体时间：One-, three- and twelve-months post-treatment
The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.
One-, three- and twelve-months post-treatment

次要结果测量

结果测量
措施说明
大体时间
儿童全球评估量表（CGA）
大体时间：基线，三个月和十二个月后处理
CGA测量在1到100范围内的单个项目上的全局功能，其值更高，表明功能更好。 临床医生等级。
基线，三个月和十二个月后处理
情绪调节量表的困难-16个项目版本（DERS -16）
大体时间：基线，三个月和十二个月后处理
DERS-16衡量情绪调节的困难。 总分从16到80不等，得分较高，表明困难更大。 自评（青少年和父母）。
基线，三个月和十二个月后处理
儿童健康公用事业9D（CHU-9D）
大体时间：基线，三个月和十二个月后处理
CHU-9D衡量与健康相关的生活质量。 该量表有9个项目，摘要得分在9到45之间，其中更高的分数表明与健康相关的生活质量更大。 自评（青少年）。
基线，三个月和十二个月后处理
修订的儿童焦虑和抑郁量表短版（RCADS-25）
大体时间：基线，三个月和十二个月后处理
RCADS-25测量儿童和青少年的抑郁症和焦虑症状。 此版本的总分在0到75之间的总分为25个项目，得分较高，表明症状水平更高。 自评（青少年）。
基线，三个月和十二个月后处理
Trimbos/IMTA问卷调查与精神病相关的成本（TIC-P）
大体时间：基线，三个月和十二个月后处理
TIC-P衡量医疗保健和社会资源的使用，包括有关医疗资源使用，药物，学校缺勤和父母生产力损失的项目。 自评（父）。
基线，三个月和十二个月后处理
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
大体时间：Baseline, one-, three- and twelve-months post-treatment
The DSHI-Y measures the frequency of the most common NSSI behaviors. Change in NSSI frequency from baseline to respective follow-up will be a secondary outcome. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.
Baseline, one-, three- and twelve-months post-treatment
Borderline symtom checklist supplement (BSL)
大体时间：Baseline, one-, three- and twelve-months post-treatment
The BSL supplement measures the frequency of self-destructive behaviors. We will measure behaviors of self-harm, suicide attempt, binge eating, self-induced vomiting, high-risk activities, getting drunk, substance use, medication misuse, outbreaks of anger/physical attacks and impulsive/shameful sexual encounters, resulting in a total score between 0 to 40 where a higher score indicates greater frequency of self-destructive behaviors. Self-rated (adolescent).
Baseline, one-, three- and twelve-months post-treatment
The Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
大体时间：Baseline, one-, three- and twelve-months post-treatment
The CCNES-A measures parental coping in response to adolescents' negative emotions. The CCNES-A consists of nine hypothetical scenarios accompanied by six types of responses (i.e., emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses). Separate summary scores are calculated per subscale (type of response) and ranges from 1 to 7, with higher scores indicating greater usage of a certain parental coping style. Self-rated (parent and adolescent).
Baseline, one-, three- and twelve-months post-treatment

其他结果措施

结果测量
措施说明
大体时间
互联网干预患者依从性量表（IIPA）
大体时间：治疗第3周和治疗后（第12周）
IIPA衡量患者坚持指导互联网传递的行为干预措施。 该量表有5个项目，总分范围从0到20，其中0表示没有依从性和20个完美依从性。 临床医生等级。
治疗第3周和治疗后（第12周）
客户满意度问卷（CSQ）
大体时间：治疗后（第12周）
CSQ测量治疗的满意度。 该量表有8个项目，摘要得分范围从8到32，得分较高，表明治疗满意度更高。 自评（青少年和父母）。
治疗后（第12周）
治疗师时间
大体时间：治疗后（第12周）
临床医生报告了在治疗上花费的时间。
治疗后（第12周）
完整的会话和模块数量
大体时间：治疗后（第12周）
临床医生报告了青少年和父母的完整会议和模块的数量。
治疗后（第12周）
治疗速度适应
大体时间：治疗后（第12周）
临床医生报告了可能存在或不存在治疗适应性（例如，治疗师接触的变化或重点关注的材料）。
治疗后（第12周）
改编的ICBT治疗师评级量表（ICBT-TRS）
大体时间：通过学习完成，平均1年
治疗师的行为分别为0（缺乏行为），1（表现不足）或2（胜任）。 由经验丰富的临床主管评为。
通过学习完成，平均1年
参与者评价的依从性
大体时间：治疗第3周
两个项目要求参与者在过去一周的遵守情况上进行评分。 自评（青少年）。
治疗第3周
信誉
大体时间：治疗第3周
从上一周开始，有两个项目要求参与者对治疗信誉的变化进行评分。 自评（青少年）。
治疗第3周
不利事件
大体时间：治疗后（第12周）
要求参与者报告，描述和评估因其参与治疗而引起的任何负面影响或不良事件的不适/影响。 参与者在发生时对潜在不利事件的影响进行评分，而今天的比例从1到4，在1到4的范围内，更高的分数表明影响更大。 自评（青少年和父母）。
治疗后（第12周）
伴随的治疗
大体时间：治疗后（第12周），治疗后三个月和三个月
参与者报告了在试验期间的存在，类型，重点和更改任何其他潜在伴随治疗的方法。 自评（青少年和父母）。
治疗后（第12周），治疗后三个月和三个月
关于自我伤害（ISA）的陈述清单
大体时间：基线
ISA衡量频率，功能，发病年龄，具有停止自我伤害的经验和意愿。 有39个描述自我伤害的常见功能的项目。 要求参与者通过将陈述标记为“不相关”，“部分相关”或“非常相关”来评估某个功能是否适用于他们。 自评（青少年）。
基线
哥伦比亚自杀严重性评级量表（C-SSRS）-6个项目版本
大体时间：基线
C -SSRS -6个项目版本测量自杀构想和行为的频率和严重性。 临床医生等级。
基线
哥伦比亚自杀严重性评级量表（C-SSRS）
大体时间：第1周至12周
有关C-SSR的自杀行为的两个项目用于衡量治疗期间的自杀性。 这些项目涉及过去七天的准备行为和自杀企图。 自评（青少年）。
第1周至12周
情绪调节量表的困难-16个项目版本（DERS -16）
大体时间：第1周至12周
DERS-16衡量情绪调节的困难。 总分从16到80不等，得分较高，表明困难更大。 自评（青少年）。
第1周至12周
自我评估和评估者评估的非自杀性自伤（NSSI）报告经验
大体时间：基线、治疗后一个月或三个月
青少年将被询问两个关于报告非自杀性自伤（NSSI）所用格式的问题：（1）"您在不同格式中报告NSSI的体验如何？"，以及当两种报告格式之间出现差异时：（2）"您更倾向于哪种频率评级？"。 这两个问题将由评估员在一次评估会话中进行管理。
基线、治疗后一个月或三个月
Treatment benefit
大体时间：Twelve-months post-treatment
Participants are asked to rate, using a single item, the perceived benefit of the intervention-specifically, how much of the knowledge gained continues to help them today. Self-rated (adolescent and parent).
Twelve-months post-treatment
Deliberate Self-harm Inventory - Youth version (DSHI-Y)
大体时间：Week 1 to 12, and post-treatment (week 12)
The DSHI-Y measures the frequency of the most common NSSI behaviors. Self-rated (adolescent).
Week 1 to 12, and post-treatment (week 12)
The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
大体时间：Through study completion for primary outcome measure and endpoint, an average of 3 years
S-NoMAD measures implementation of interventions from a normalization process theory perspective. The first section in S-NoMAD includes questions about the respondent, the second (2 items) and third (20 items) include questions about the intervention. The items in the second section are answered on a 10-point Likert scale ranging from "Not at all" to "Completely". The items in the third section are answered using a 5-point Likert scale, ranging from "Disagree Strongly" to "Agree Strongly". Participating clinicians answer the S-NoMAD once, after they have treated at least three families with the intervention (i.e., to have some experience of the intervention).
Through study completion for primary outcome measure and endpoint, an average of 3 years
Demographical and clinical background data
大体时间：Baseline
Current mental health disorders, age, previous and current treatment. Clinician-rated. Gender and sexual orientation. Self-rated (adolescent). Country of birth, living situation, parental occupation, parental academic degree, and parental history of mental health disorders. Self-report (parent)
Baseline
Lifestyle behaviors
大体时间：Baseline
Four questions asking participants to rate how frequently they engage in the following activities: eating candy, drinking soda, playing video or computer games, and watching movies. Clinician-rated and self-rated (adolescent)
Baseline
Number of healthcare visits
大体时间：1 to 10 years post-treatment
Registry data from the National Patient Register.
1 to 10 years post-treatment
Academic performance
大体时间：1 to 10 years post-treatment
Grades and eligibility in primary school and upper secondary school, and highest education level. Registry data from the Swedish National Agency for Education and the Swedish longitudinal integrated database for health insurance and labour market studies (LISA).
1 to 10 years post-treatment
Mental health disorders
大体时间：1 to 10 years post-treatment
Registered psychiatric disorders. Registry data from the National Patient Register.
1 to 10 years post-treatment
Occupation
大体时间：1 to 10 years post-treatment
Occupation, including unemployment and sick leave. Registry data from the Swedish longitudinal integrated database for health insurance and labour market studies (LISA).
1 to 10 years post-treatment
Reasons for eventual death
大体时间：1 to 10 years post-treatment
Registry data from the National Cause of Death Register.
1 to 10 years post-treatment
Prescription of psychotropics
大体时间：1 to 10 years post-treatment
Registry data from the National Prescribed Drug Register.
1 to 10 years post-treatment
Suicide attempts
大体时间：1 to 10 years post-treatment
Suicide attempts registered by the health care. Registry data from the National Patient Register and Regional Healthcare Registers.
1 to 10 years post-treatment
The Revised Child Anxiety and Depression Scale (RCADS)
大体时间：1 to 10 years post-treatment
The RCADS measures symptoms of depression and anxiety in children and adolescents. RCADS has 47 items with a total score between 0 and 141, with higher scores indicating greater levels of symptoms. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).
1 to 10 years post-treatment
Kidscreen-10
大体时间：1 to 10 years post-treatment
The Kidscreen-10 measures quality of life through 10 items. The summary score ranges from 10 to 50 where a higher score indicates greater quality of life. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).
1 to 10 years post-treatment
Children's Global Assessment Scale (CGAS)
大体时间：1 to 10 years post-treatment
The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Registry data from the National Quality Register for Child and Adolescent Mental Health Services (Q-BUP).
1 to 10 years post-treatment
Credibility/Expectancy Questionnaire (CEQ) - 1 item version
大体时间：Treatment week 2
CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).
Treatment week 2

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Karolinska Institutet

合作者

Vastra Gotaland Region
Region Skane
Region Stockholm

调查人员

  • 首席研究员：Johan Bjureberg, PhD、Karolinska Institutet
  • 首席研究员：Olivia Ojala, PhD、Karolinska Institutet

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月22日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2040年12月1日

研究注册日期

首次提交

2026年4月25日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月7日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2024-04650-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The data is pseudonymized in accordance with Swedish and European Union laws and cannot be anonymized and published in an open repository. Study participants have consented to sharing their data with international researchers for meta-analyses. Aggregated data can be provided upon reasonable request on a case-by-case basis in compliance with current legislation and ethical permits.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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