NCT06724666招募中不适用
Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
Babes-Bolyai University4 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2025年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 198
- 试验地点
- 4
- 主要终点
- Internalizing problems
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and/ or depression. The main questions it aims to answer are:
- What is the clinical efficacy of the Internet-delivered intervention?
- How accurate is the prediction model in predicting who will respond to treatment? Participants will undergo non-invasive fMRI to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the Internet-delivered intervention or control group.
详细描述
To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.
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 (Investigator, Outcomes Assessor)
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
- •elevated symptoms of anxiety or depression/ internalizing problems (T score> 60) at intake (based on Youth self-report completed by adolescents)
- •primary diagnosis of an anxiety/depressive disorder based on DSM-5 criteria according to ADIS-5-C/P interview
- •age 13-17
- •able to read and understand Romanian language
- •Currently unmedicated or on stable and adequate doses of medication for at least 6 weeks before treatment onset
- •Internet access
排除标准
- •severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview)
- •any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, behavioral activation, unavailable for the next 3 months),
- •active suicidal ideation (assessed by child psychiatrist during clinical interview) in the last month
- •currently following CBT/ psychotherapy for anxiety/depression, in the last 6 months
- •fMRI incompatible (based on safety questionnaire)
- •Being diagnosed with an intellectual disability, pervasive developmental disorder, an alcohol and/or substance dependence disorder, reading disabilities (based on clinical interview).
- •Current treatment with benzodiazepines
结局指标
主要结局
Internalizing problems
时间窗: baseline, after 8 weeks of intervention, 6 months follow-up
Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents.
次要结局
- Clinical diagnosis(administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention)
- Global functioning(baseline, after 8 weeks of intervention, 6 months follow-up)
- Severity(baseline, after 8 weeks of intervention, 6 months follow-up)
- Improvement(after 8 weeks of intervention, 6 months follow-up)
- Comorbid problems(baseline, after 8 weeks of intervention, 6 month follow-up)
- Life satisfaction(baseline, after 8 weeks of intervention, 6 months follow-up)
- Satisfaction with the Internet-delivered intervention(after 8 weeks of intervention)
- Working alliance(after 8 weeks of intervention)
- Automatic thoughts(baseline, after 8 weeks of intervention, 6 month follow-up)
- Credibility and expectations(week 2)
- Credibility and expectations based on primary outcome measure(baseline)
- Anxiety and depressive symptoms(baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up)
- Avoidance(baseline, after 8 weeks of intervention, 6 month follow-up)
- Parental distress(baseline)
- Adolescent anxiety and depressive symptoms as reported by parents(baseline, after 8 weeks of intervention, 6 month follow-up)
- Parental accommodations(baseline)
研究者
Costina-Ruxandra Poetar
Assistant professor
Babes-Bolyai University
研究点 (4)
Loading locations...
相似试验
Unknown
不适用
Internet-delivered Transdiagnostic Intervention for Anxiety and DepressionDysthymic DisorderSpecific PhobiaSocial PhobiaDepressionObsessive-Compulsive DisorderGeneralized Anxiety DisorderPanic DisorderNCT02739607West University of Timisoara100
Unknown
不适用
RECOVERY: A Transdiagnostic Intervention for Anxiety and DepressionDysthymic DisorderPanic DisorderSocial PhobiaGeneralized Anxiety DisorderSpecific PhobiaDepressionNCT03917550West University of Timisoara260
尚未招募
不适用
UNIPDES- An Internet-Based Transdiagnostic Intervention for College Students' Psychological SymptomsMental Health IssueNCT06245200Anadolu University330
已完成
不适用
Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and DepressionDepression, PostpartumAnxietyNCT04012580University of Regina60
已完成
不适用
Effectiveness of a Transdiagnostic Internet-based Treatment for Emotional DisordersAnxietyDepressionNCT02345668Universitat Jaume I200