NCT03247075已完成不适用
Internet-delivered Cognitive Behavior Therapy Versus Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Clinician Severity Rating (CSR)
研究概览
简要总结
Social anxiety disorder among youth is highly prevalent and causes significant impairment in the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective treatment, research suggests that many young people with this disorder do not have access to good-quality CBT. Internet-delivered CBT could be an effective method to increase availability of evidence-based treatments for youth with social anxiety disorder. The primary objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized controlled trial with N = 101 participants. Participants will be randomized to either the active treatment arm (guided ICBT) or to a control condition (guided internet-delivered support and counseling). Follow-ups will be conducted at 3 and 12 months after post-assessment.
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A principal diagnosis of social anxiety disorder, as defined by DSM-5
- •Age between 10 and 17 years
- •Ability to read and write Swedish
- •Daily access to the internet through a computer or similar device
- •A parent or caregiver 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 alcohol or substance abuse
- •Occurrence of domestic violence
- •Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
结局指标
主要结局
Clinician Severity Rating (CSR)
时间窗: 6 months (14 months including follow-up)
A 0-8 rating by a professional assessor, specifying the severity of social anxiety
次要结局
- Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders(Measured over the course of 6 months (14 months including follow-up))
- Children's Global Assessment Scale (CGAS)(Measured over the course of 6 months (14 months including follow-up))
- Client Satisfaction Questionnaire (CSQ-) - Child version(Measured only at post-treatment)
- Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder(Measured over the course of 6 months (14 months including follow-up))
- Clinical Global Impression - Improvement (CGI-I)(Measured over the course of 3 months (12 months including follow-up))
- Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version(6 months (14 months including follow-up))
- Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version(Measured over the course of 6 months (14 months including follow-up))
- Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version(Measured over the course of 6 months (14 months including follow-up))
- Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version(Measured over the course of 6 months (14 months including follow-up))
- Anticipatory social behaviors scale (ASBQ)(Measured over the course of 6 months (14 months including follow-up))
- Treatment credibility and expectancy - Parent version(Measured at one time-point, at week three in the allocated intervention.)
- Education, Work and Social Adjustment Scale (EWSAS) - Parent version(Measured over the course of 6 months (14 months including follow-up))
- Client Satisfaction Questionnaire (CSQ-) - Parent version(Measured only at post-treatment)
- Focus of attention questionnaire (FAQ)(Measured over the course of 6 months (14 months including follow-up))
- The Subtle Avoidance Frequency Examination (SAFE)(Measured over the course of 6 months (14 months including follow-up))
- Alcohol Disorder Identification Test (AUDIT)(Measured over the course of 6 months (14 months including follow-up))
- Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version(Measured over the course of 6 months (14 months including follow-up))
- The Negative Effects Questionnaire (NEQ)(Measured only at post-treatment)
- Post-event processing questionnaire revised (PEPQ-R)(Measured over the course of 6 months (14 months including follow-up))
- The Child Health Utility 9D (CHU 9D) - Child version(Measured over the course of 6 months (14 months including follow-up))
- Internet intervention Patient Adherence Scale (iiPAS)(Measured at mid-treatment (week 5) and at post-treatment (week 10))
- Treatment credibility and expectancy - Child version(Measured at one time-point, at week three in the allocated intervention.)
- Hospital Anxiety and Depression Scale (HADS)(Measured only at pre-treatments)
- Drug Use Disorders Identification Test (DUDIT)(Measured over the course of 6 months (14 months including follow-up))
- Family Accommodation Scale-Anxiety (FASA)(Measured over the course of 6 months (14 months including follow-up))
- School absenteeism(Measured over the course of 6 months (14 months including follow-up))
研究者
Eva Serlachius
Associate professor, child psychiatrist, MD
Karolinska Institutet
研究点 (2)
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