Stepped Versus Stratified Care for Anxiety Disorders in Youth: A Pragmatic Non-Inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- Clinical Global Impressions - Improvement Scale
研究概览
简要总结
The goal of this clinical trial is to compare stepped care to stratified care as overall healthcare models for children and adolescents aged 8-17 with anxiety disorders. It addresses one main question:
• Is stepped care non-inferior to stratified care in supporting participants to achieve a treatment response?
Researchers will compare two care models:
- Stepped care, where all participants begin with 14 weeks of internet-delivered cognitive behavioral therapy (ICBT) and receive an additional 14 weeks of personalized in-person CBT if needed.
- Stratified care, where participants are assigned to either 14 weeks of ICBT or 14 weeks of in-person CBT based on clinical complexity, and may also receive additional 14 weeks of in-person CBT if necessary.
Participants will:
- Be randomly assigned to one of the two care models.
- Complete a wide range of assessments at baseline, during treatment, and at 4, 8, 12, and 24 months, with the 8-month point as the primary endpoint.
- Receive either ICBT, in-person CBT, or both, depending on their care model and response to treatment.
- Participate in ancillary studies involving DNA sampling, cognitive testing, and national registry linkages to help predict treatment response and long-term outcomes.
详细描述
A detailed description is available in the full study protocol. All study protocol versions can be accessed at the Open Science Framework (https://osf.io/a9qhw/).
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
- Double (Participant, Outcomes Assessor)
盲法说明
Statistical analyst
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8.0 to 17.5 years. Confirmed by the child and/or caregiver.
- •Principal DSM-5-TR anxiety disorder of social anxiety disorder, generalized anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, or agoraphobia. Confirmed by the structured diagnostic interview (DIAMOND-KID). "Principal" indicates that the anxiety disorder is judged by the clinician to be in most urgent need of treatment (among potential co-occurring disorders).
- •Available caregiver who can support the child in treatment. Confirmed by the caregiver.
- •Child and at least one caregiver can read, write, and communicate in Swedish. Confirmed by the child and/or caregiver.
- •Child (≥13 years) and caregiver have access to a Swedish electronic identification (BankID or Freja eID).
- •Access to the internet. Confirmed by the child and/or caregiver.
- •Ability to attend in-person CBT sessions at the clinic. Confirmed by the child and/or caregiver.
排除标准
- •Principal DSM-5-TR anxiety disorder of specific phobia concerning the domain of blood-injection-injury (due to the ICBT program not including relevant information on applied-tension techniques to avoid fainting during exposure exercises). Confirmed by a specific phobia of this sort being classified as the most functionally impairing anxiety disorder during the structured diagnostic interview (DIAMOND-KID).
- •Ongoing psychological treatment for an anxiety disorder. Confirmed by the child and/or caregiver.
- •Social/familial/educational difficulties in more immediate need of management than an anxiety disorder. Confirmed by the assessor through information from the child and/or caregiver and/or other available sources.
- •Immediate risk to self or others that require urgent attention, such as suicidality. Confirmed by the assessor through information from the child and/or caregiver and other available sources.
- •The potential participant has a relative (e.g., sibling, cousin) included in the study. Confirmed by the assessor through information from the caregiver and other available sources.
研究组 & 干预措施
Stepped Care
All participants in stepped care will receive internet-delivered cognitive-behavioral therapy (ICBT) in the first Treatment course (A). Participants who have not responded to treatment or continue to exhibit clinical levels of anxiety severity will be offered personalized in-person CBT in the second Treatment course (B).
干预措施: Personalized in-person cognitive-behavioral therapy (Behavioral)
Stepped Care
All participants in stepped care will receive internet-delivered cognitive-behavioral therapy (ICBT) in the first Treatment course (A). Participants who have not responded to treatment or continue to exhibit clinical levels of anxiety severity will be offered personalized in-person CBT in the second Treatment course (B).
干预措施: Internet-delivered cognitive-behavioral therapy (Behavioral)
Stratified Care
In stratified care, Treatment course A aims to allocate approximately half of the participants to internet-delivered cognitive-behavioral therapy (ICBT) and the other half to personalized in-person CBT, based on their algorithm-generated clinical complexity score. Identical to stepped care, those who have not responded to treatment or continue to exhibit clinical levels of anxiety severity after Treatment course A will be offered personalized in-person CBT in Treatment course B.
干预措施: Internet-delivered cognitive-behavioral therapy (Behavioral)
Stratified Care
In stratified care, Treatment course A aims to allocate approximately half of the participants to internet-delivered cognitive-behavioral therapy (ICBT) and the other half to personalized in-person CBT, based on their algorithm-generated clinical complexity score. Identical to stepped care, those who have not responded to treatment or continue to exhibit clinical levels of anxiety severity after Treatment course A will be offered personalized in-person CBT in Treatment course B.
干预措施: Personalized in-person cognitive-behavioral therapy (Behavioral)
结局指标
主要结局
Clinical Global Impressions - Improvement Scale
时间窗: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
The Clinical Global Impressions - Improvement (CGI-I) Scale is a 1-item measure where a trained interviewer uses all available information about the patient to rate improvement on a 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. In this study, improvement on the CGI-I is assessed by comparing the current status of the participant to their baseline condition. In line with previous studies, a score of 1 or 2 on the CGI-I is classified as a treatment response and scores of 3 to 7 as non-response. This binary variable is the primary outcome of the trial.
次要结局
- Pediatric Anxiety Rating Scale(Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up))
- Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version(Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up))
- Clinical Global Impressions Scale-Severity(Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up))
- Children's Global Assessment Scale(Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up))
- Child Anxiety Life Interference Scale-Revised(Baseline; 4 months (17 to 20 weeks post-randomization); 8 months (35 to 40 weeks post-randomization, primary endpoint); 12 months; 24 months)
- Proportion of participants who do not adhere to the assigned treatment/s(4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint))
- Adverse events(4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint))
- Revised Children's Anxiety and Depression Scale(Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up))
研究者
Matti Cervin
Associate Professor, Senior Clinical Psychologist
Region Skane