Development, Feasibility and Acceptability of an Internet-based Cognitive Behavioral (iCBT) Intervention for Adolescents With Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The Youth Online Diagnostic Assessment (YODA)
研究概览
简要总结
The aim of the feasibility study is twofold: 1) to test the feasibility of the study design, and 2) to test the preliminary efficacy and the acceptability of a new iCBT intervention when delivered with different levels of therapist support. The feasibility trial will provide important information on the initial participant responses, and on how to properly collect data in the subsequent RCT.
The feasibility trial is conducted as a randomized study with 16 participants consisting of two conditions: 1) guided iCBT, and 2) on-demand iCBT, both to be completed over a 14-week period. Participants in the guided iCBT condition will receive the new iCBT intervention with planned feedback after each completed module. Participants in the on-demand iCBT condition will receive the intervention with on-demand feedback that is participant-initiated. In both conditions, the therapist may spend a max. of 15 minutes giving feedback per module. As there is no evidence on what amount of therapist support is sufficient for adolescents, the allowed time spent giving feedback will not differ between the two conditions in the feasibility trial. Thus, data on engagement will be collected to inform how the two treatment conditions differ. The trial includes data points at pre-treatment (T1) and post-treatment (T2) where the same measures will be administered as are planned in the RCT.
Acceptability of the intervention will be investigated by conducting semi-structured interviews with the participants. The interview will include an evaluation of the intervention, client satisfaction and potential reasons for drop out.
The results from the feasibility trial will be used to inform the subsequent RCT and to revise the intervention, procedures, and conditions if needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 12 and 17 years of age
- •Primary anxiety diagnosis
- •Must have the ability to read and write Danish
- •Must have Internet access
- •Must have a parent able to participate in the treatment alongside the adolescent
排除标准
- •Specific phobia of blood-injection-injury type
- •An autism spectrum disorder
- •Psychotic symptoms
- •Bipolar disorder
- •Current suicidal ideation or self-mutilating behavior
- •Current alcohol or substance abuse
- •Moderate to severe depression
- •Current eating disorder
结局指标
主要结局
The Youth Online Diagnostic Assessment (YODA)
时间窗: Pre-intervention, post-intervention (12 weeks after commencing treatment)
An online diagnostic assessment tool that assesses DSM-5 anxiety disorders and specific phobias. Each present diagnosis is assigned a clinician-rated severity score ranging from 0 (minimal/absent) to 4 (pervasive). Typically subclinical disorders would receive a rating of 0 or 1, and clinical disorders a rating of 1 to 4.
Spence Children's Anxiety Scale (SCAS-C/P)
时间窗: Pre-intervention, post-intervention (12 weeks after commencing treatment)
A 44-item self-report questionnaire assessing anxiety symptoms of six different anxiety disorders in DSM-IV: generalized anxiety, panic/agoraphobia, social phobia, separation anxiety, obsessive compulsive disorder and physical injury fears. Symptoms are rated on a 4-point frequency scale ranging from 0 (never) to 3 (always) (min. = 0; max. = 114). A higher score indicates increased symptom severity. The Danish version has demonstrated good psychometric properties
次要结局
- Child Anxiety Life Interference Scale (CALIS)(Pre-intervention, post-intervention (12 weeks after commencing treatment))
- The Patient Health Questionnaire (PHQ-9)(Pre-intervention, post-intervention (12 weeks after commencing treatment))