Fatigue in Teenagers on the Internet (FitNet); Efficacy of Web-based Cognitive Behavioural Treatment for Adolescents With the Chronic Fatigue Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- Severity of fatigue
研究概览
简要总结
The aim of this study is to determine the efficacy of FITNET (web-based cognitive behavioural treatment) for adolescents with Chronic Fatigue Syndrome (CFS) in The Netherlands. The second goal of the study is to establish predictors of outcome. It is very important to know the characteristics of patients who will benefit from Cognitive Behavioural Treatment (CBT) and who will not. Possible predictors of outcome are: age, depression, anxiety, fatigue of the mother, parental bonding, self-efficacy, body consciousness of child and mother, physical activity (Actometer).
详细描述
All participants will be randomized to one of the two treatment arms:
- Intervention with web-based cognitive behavioral treatment
- Usual care
The duration of the cognitive behavioural program is limited to 6 months. The adolescents who have been assigned to the usual care will get the opportunity to attend the program after these 6 months. The total follow-up time is 12 months after the start of the web-based program.
The web-based program is developed for both the adolescents and the parents. The program consists of two parts, a psycho-educational part and a cognitive behavioural part consisting of 21 treatment modules. The therapist activates one or more treatment modules per week, dependent on the progress of the participant. Within a treatment module the participant will keep several journals, answer questions and do several assignments. All answers are sent to the therapist, with whom a weekly email contact will be realized.
Efficacy of the web-based program will be determined after 6 months. There will be a follow-up measurement at 12 months.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents (12 - 18 years) with Chronic Fatigue Syndrome
排除标准
- •Score greater than or equal to 44 on the Stait-Trait Anxiety Inventory for Children
- •Score greater than or equal to 20 on the Children's Depression Inventory
- •No availability of computer and/or internet
- •Risk of suicide
- •Mental retardation
结局指标
主要结局
Severity of fatigue
时间窗: one year
Physical functioning as measured by the subscale physical functioning
时间窗: one year
School presence
时间窗: one year
次要结局
- Self-rated improvement(one year)