Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- The Youth Online Diagnostic Assessment - Child and Parent Versions
研究概览
简要总结
The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to the
Diagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:
- If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.
- What effect different degrees of therapist support have on the treatment.
Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.
Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment.
详细描述
Introduction
Among children and adolescents the most prevalent mental health conditions are anxiety disorders, with around 5-12% of youth in western countries fulfilling the criteria for an anxiety diagnosis. Evidence points to an increase in the prevalence of anxiety disorders during the transition from childhood to adolescence and from adolescence to adulthood up to age 30. Untreated anxiety disorders tend to chronify or become recurrent in the developmental course and persist into adulthood.
Cognitive behavioral therapy (CBT), in both individual and group format, is effective in treating young people with anxiety. Despite the existence of effective treatment options and the possible long-term consequences associated with untreated anxiety disorders in youth, it is estimated that less than 25% of children and adolescents with anxiety disorders receive professional help, with fewer receiving evidence-based treatment. Frequently mentioned barriers for adolescents opting to seek treatment include social stigma, shyness and fear of peer rejection, preference for self-reliance, confidentiality, privacy and anonymity concerns, worries concerning treatment costs, transportation or waiting times and limited availability of psychological treatment. Thus, it is of the utmost importance to consider these barriers when developing interventions to overcome these and thus increase treatment accessibility.
Internet-based cognitive behavioral therapy (iCBT) may be an effective alternative to face-to-face treatment, that can address some of the aforementioned barriers to treatment by providing greater flexibility, greater autonomy, reduced expenses, and eliminate travel time. To date, fourteen randomized controlled trials (RCTs) have evaluated iCBT programs in both children and adolescents with anxiety disorders. Four of these included predominantly or only adolescents and showed promising results with between group effect sizes ranging from d = 0.65-1.04 at follow-up.
Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
As the study concerns itself with psychotherapy and examines the difference in therapist support, it is practically impossible to blind participants and clinicians, and thus they are not blinded. The research team is involved in the day-to-day operation of the project, including the screening for suicidality, why blinding of the research team is also practically impossible with the current setup. However the analyzes of the trial results will be pseudo-anonymized, so that only the ID number appears on the data sheet in order to get as close to blinding as possible in relation to the research design.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 12 and 17 years of age.
- •Have a principal anxiety diagnosis according to DSM-5 criteria.
- •The ability to read and write Danish.
- •Internet access.
- •A parent able to participate in treatment alongside the adolescent.
排除标准
- •Autism spectrum disorder.
- •Attention deficit hyperactivity disorder.
- •Psychotic symptoms.
- •Bipolar disorder.
- •Current suicidal ideation or self-mutilating behavior.
- •Current alcohol or substance abuse.
- •A score of 5 or above on ADIS
- •Current eating disorder.
- •Received CBT for an anxiety disorder within the past 12 months.
结局指标
主要结局
The Youth Online Diagnostic Assessment - Child and Parent Versions
时间窗: Pre-treatment, immediately after treatment and at 3-month follow-up
An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias based on the Anxiety and Related Disorders Interview Schedule for DSM-5, which is considered the golden standard.
Spence Children's Anxiety Scale- Child and Parent Versions
时间窗: Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up
A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV. The responses are scored on a 4 point scale ranging from 0 to 3, with a minimum score of 0 and a maximum score of 114, higher scores mean a higher level of anxiety.
次要结局
- Child Anxiety Life Interference Scale- Child and Parent Version(Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up)
- The Mood and Feelings Questionnaire- Child and Parent Version(Pre-treatment, immediately after treatment and at 3- 6- 12-month follow-up)
- Working Alliance Inventory - Short Form(Immediately after treatment and every 14 days during the treatment period)
- Working Alliance Inventory for Online Interventions(Immediately after treatment)
研究者
Kim Mathiasen
Associate Professor
Region of Southern Denmark