Internet-delivered Cognitive Behavioral Therapy for Adolescents With Generalized Anxiety Disorder - a Multiple Baseline Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Brief Penn State Worry Questionnaire for Children
研究概览
简要总结
This multiple baseline evaluation aims to test the feasibility and preliminary effectiveness of Internet-delivered cognitive behavioral therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD).
详细描述
This pilot study aims to test Internet-delivered Cognitive Behavioral Therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD)
The study has a single case research design (multiple baseline) and will include 12 participants with GAD according to a semi structured diagnostic interview.
Participants will be randomized to either two, six or ten weeks baseline measurements prior to starting treatment, and will thus work as their own controls.
Primary outcome measures will be collected at 10 weeks after treatment start. Follow-up assessments will be made three month after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •A score on the Penn State Worry Questionnaire for Children (PSWQ-C) of > 30
- •Fulfilling DSM-5 criteria for Generalized Anxiety Disorder
- •No other disorder or symptoms present in need of more urgent treatment
- •Aged between 13 and 17 years
- •Ability to read and write in Swedish
- •A parent or caregiver that is able to participate in the treatment
- •Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
- •No other ongoing psychological treatment for any disorder
排除标准
- •The presence of symptoms suggestive of a current diagnosis of Autistic Spectrum Disorder, Schizophrenia, Bipolar Disorder, Anorexia Nervosa, Bulimia, or Substance Use Disorder
- •Present risk of suicide
- •Present 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)
研究组 & 干预措施
Internet-delivered CBT
Internet-delivered Cognitive Behavioral Therapy (ICBT) for GAD, 10 weeks. Patients and their parents work with separate programs via the Internet. Both have contact with a therapist. Participants practice awareness of worry through daily worry monitoring. They identify their own behaviors that reinforce worry, i.e. control and avoidance behaviors. The program gives a rationale for behavior change, which is then implemented. Participants practice problem solving and exposure to uncertainty inducing situations and thoughts. Parents receive support and psycho education about worry. They practice alternative parental behaviors, which decrease focus on worry while validating the child's feelings. Treatment contains planning for maintenance of treatment gains for both patients and parents.
干预措施: Internet-Delivered Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Brief Penn State Worry Questionnaire for Children
时间窗: 10 weeks after baseline
Self-assessment of excessive worry for individual analysis in multiple baseline evaluation
Penn State Worry Questionnaire for Children
时间窗: 10, 14 and 22 weeks after baseline
Child and parent version, lower values indicating decrease in worry. Assessments used in group statistical analysis of clinical outcome
次要结局
- Children's Global Assessment Scale(10, 14 and 22 weeks after baseline)
- Brief Intolerance of Uncertainty Scale(10, 14 and 22 weeks after baseline)
- Brief Cognitive Avoidance Questionnaire(10, 14 and 22 weeks after baseline)
- Negative Problem Orientation Questionnaire, abbreviated(10, 14 and 22 weeks after baseline)
- Revised Children's Anxiety and Depression Scale(10, 14 and 22 weeks after baseline)
- Education, Work and Social Adjustment Scale(10 and 22 weeks after baseline)
- Clinical Global Impression - Improvement(10, 14 and 22 weeks after baseline)
- Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV(10, 14 and 22 weeks after baseline)
- Clinician Severity Rating(10, 14 and 22 weeks after baseline)
研究者
Eva Serlachius
Associate professor
Karolinska Institutet