Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Clinician Severity Rating (CSR)
研究概览
简要总结
The primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific phobia) in a randomized trial where participants will be allocated to either ICBT or to a supportive control condition. Non-responders (defined as those participants who still uphold their primary anxiety disorder after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are conducted at 3 and 12 months after treatment completion.
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)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary diagnosis of any of the following anxiety disorders, as defined by DSM-V (social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder or specific phobia)
- •Age between 8 and 12 years
- •Ability to read and write Swedish
- •Daily access to the internet
- •A parent that is able to co-participate in the treatment
- •Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
排除标准
- •Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
- •Present risk of suicide
- •Ongoing substance dependence
- •Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
研究组 & 干预措施
ICBT
Internet-based cognitive behavior therapy
干预措施: Internet-based CBT (Behavioral)
Supportive control
Control participants has weekly contact with a therapist and receives internet-based training in child directed play. Participants are informed that this training will not likely reduce anxiety.
结局指标
主要结局
Clinician Severity Rating (CSR)
时间窗: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of anxiety disorder severity, after 12 weeks and at 3- and 12 months after treatment
次要结局
- Clinical Global Impression - Improvement (CGI-I)(Assessed at Post, 3-month and 12-month Follow-up)
- Revised Children´s Anxiety and Depression Scale - Parent version (RCADS-P)(Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up)
- Measurement of compliance to exposure assignments and anxiety levels, through mobile app(During the 12 weeks of ICBT)
- Presence of DSM Anxiety disorder(Assessed at Pre, Post, 3-month and 12-month Follow-up)
- Children´s Globas Assessment Scale (CGAS)(Assessed at Pre, Post, 3-month and 12-month Follow-up)
- Education, Work and Social Adjustment Scale - Child version (EWSAS-C)(Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up)
- Education, Work and Social Adjustment Scale - Parent version (EWSAS-P)(Assessed at Pre, Mid-6 weeks, Post, 3-month and 12-month Follow-up)
- Technology Acceptance Scale - Parent (TAS-P)(Assessed at Mid-3 weeks and Post)
- KIDSCREEN-10 Child version(Assessed at Pre, Post, 3-month and 12-month Follow-up)
- KIDSCREEN-10 Parent version(Assessed at Pre, Post, 3-month and 12-month Follow-up)
- Unintended treatment effects(Assessed at Post)
- Specific Phobia Questionnaire - Child version (SPQ-C)(Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up)
- Revised Children´s Anxiety and Depression Scale - Child version (RCADS-C)(Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up)
- Technology Acceptance Scale - Child (TAS-C)(Assessed at Mid-3 weeks and Post)
- Hospital Anxiety and Depression Scale - Parents (HADS)(Assessed at Pre)
- Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P)(Assessed at Pre, Post, 3-month and 12-month Follow-up)
- Specific Phobia Questionnaire - Parent version (SPQ-P)(Assessed at Pre, Mid-3 weeks, Mid-6 weeks, Mid-9 weeks, Post, 3-month and 12-month Follow-up)
研究者
Eva Serlachius
Associate professor, child psychiatrist, MD
Karolinska Institutet