ChiCTR2500113086尚未招募Unknown
Effectiveness of Digital CBT-I and BT-I combined ACT for Insomnia and Anxiety Symptoms in Youth: A Randomised Control Trial
未提供1 个研究点 分布在 1 个国家开始时间: 2025年11月24日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Rating Scale Score
研究概览
简要总结
1.To compare the effect of dCBT-I, dBT-I-ACT and Health Education in improving anxiety symptoms in youth 2.To compare the effect of dCBT-I, dBT-I-ACT and Health Education in improving insomnia symptoms in youth 3.To compare the effect of dCBT-I, dBT-I-ACT and Health Education in improving depressive symptoms, cognitive flexibility, dysfunctional beliefs about sleep, pre-sleep hyperarousal, and quality of life in youth
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- The data analyst will remain blinded to group allocation to prevent expectation or analysis bias.
入排标准
- 年龄范围
- 15 至 24（—）
- 性别
- All
入选标准
- •i.Chinese youth aged 15-24 years old,
- •ii.Presence of acute insomnia disorder as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP),
- •iii.Presence of anxiety features as defined by General Anxiety Disorder-7 (GAD-7) using cut-off of 15 for detecting moderate anxiety symptoms,
- •iv.Ability to listen, speak, and read Chinese and Cantonese, and
- •v.Written informed consent of participation into the study is given by youth and his/her parent’s if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old
- •vi.Possession of a smartphone
排除标准
- •i.A clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability,
- •ii.Having a diagnosed sleep disorder (e.g. delayed sleep phase and narcolepsy) that may potentially contribute to the disruption of sleep quantity and quality as determined by validated Diagnostic Interview for Sleep Patterns and Disorders (DISP),
- •iii.Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by The Structured Clinical Interview (SCID), and
- •iv.Currently receiving psychological treatment and/or pharmacological treatment for insomnia or anxiety disorder.
研究组 & 干预措施
Digital behavioral therapy for insomnia group
Digital behavioral therapy for insomnia combined with acceptance commitment therapy group
Digital health education goup
结局指标
主要结局
Hamilton Anxiety Rating Scale Score
Hospital Anxiety and Depression Scale Score
State-trait Anxiety Scale Score
次要结局
- Insomnia Severity Index (ISI)
- Prospective 7-day Sleep diary
- Pediatric Daytime Sleepiness Scale Score
- Dysfunctional Beliefs and Attitudes about Sleep Scale-16-item (DBAS-16)
- Acceptance and Action Questionnaire–II (AAQ-II)
- Pre-Sleep Arousal Scale Score
- White Bear Suppression Inventory (WBSI)
- The Satisfaction With Life Scale Score
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Cognitive-Behavioral and Digital Therapy for Suicide Risk in Eating DisordersNCT07417826Universitat Autonoma de Barcelona150
尚未招募
1 期
Treatment of generalized anxiety disorder: A randomized controlled trial of an internet self-help program with minimal non-therapist supportChiCTR2000032618Nil, student study114
进行中（未招募）
Phase 3 4
Managing Type 2 Diabetes: Evaluating the impact of Cognitive Behavioral TherapyCTRI/2024/04/065241Shambhavi Pandey45
尚未招募
不适用
Evaluating the Impact of Dialectical Behavior Therapy on Motivation, Self-Efficacy, and Craving in Substance Abuse Patients at OOAT Clinics in PunjabCTRI/2025/08/093844Ajay Kumar144
招募中
不适用
Internet-Based Cognitive Behavioral Therapy for MRI-Related AnxietyAnxietyClaustrophobiaClaustrophobiaAnxietyNCT07296822Johan Kihlberg60