NCT03000894已完成不适用
Cognitive Behavioral Therapy for Insomnia as a Transdiagnostic Early Intervention of Mood Disorders: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire
研究概览
简要总结
This study aims to investigate the effectiveness of transdiagnostic nurse-administered 4-session group cognitive behavioral therapy for insomnia (CBT-I) plus standard care, compared to standard care alone, for improving sleep and daytime function, enhancing recovery, preventing relapses, and reducing medication burden in patients with the first episode of mood disorders.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents
- •Aged ≥ 18 years
- •Able to to communicate in Cantonese and write in Chinese
- •First episode of depressive or bipolar disorders according to the DSM-5 diagnostic criteria
- •Having received psychiatric treatment for less than 12 months
- •Meeting the DSM-5 diagnostic criteria for insomnia disorder for at least 1 month, instead of at least 3 months, as in criterion D.
排除标准
- •Significant cognitive impairments and psychotic symptoms, based on a Mini-mental State Examination score of 23 or below and the Positive and Negative Syndrome Scale items on delusions, conceptual disorganization, and hallucinatory behavior at moderate severity or above
- •A diagnosis of schizophrenia, delusional disorder, neurocognitive disorders, or learning disability
- •Having a highly unstable medical or psychiatric condition (including strong suicidal risk) that requires hospitalization
- •Having an untreated sleep disorder, including narcolepsy, obstructive sleep apnea, and periodic leg movement disorder
- •Past or current treatment with CBT-I
- •Having a fear of speaking in a group setting or refusal to give informed consent
- •Refuse to give informed consent
结局指标
主要结局
Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire
时间窗: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
次要结局
- Change of the severity of depression symptoms measured by 17-item Hamilton Depression Rating Scale (HAM-D17)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- The number of clinic visits and hospitalizations(3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' perceived stress measured by Perceived Stress Scale(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of the severity of illness measured by Clinical Global Impressions of Severity (CGI-S)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- The number and type of relapses(3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' cognitive and somatic arousal prior to sleep onset measured by Pre-sleep Arousal Scale(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of the anxiety and depression state measured by Hospital Anxiety and Depression Scale(HADS)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' self-rated severity of physical symptoms measured by Somatic Symptom Inventory (SSI)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' sleep inhibitory behavior measured by the Sleep Hygiene Practice Scale(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' self-rated score of health state measured by 36-item Short Form Health Survey (SF-36)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' credibility to treatment measured by Credibility of treatment rating scale(Baseline and immediate post-treatment, around 8-week post-baseline (CBT-I group), Baseline (Control group))
- Change of the severity of mania symptoms measured by Young Mania Rating Scale(YMRS)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Change of subjects' self-efficacy about sleep measured by Self-Efficacy for Sleep Scale(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Prescribed medication burden(3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
- Subjects' satisfaction to CBT-I measured by treatment satisfaction scale(Immediate post-treatment (around 8-week post-baseline))
- Subjects' adherence to CBT-I measured by treatment adherence scale(Immediate post-treatment (around 8-week post-baseline))
- Change of subjects' sleep-incompatible beliefs and cognition measured by 16-item Dysfunctional Beliefs and Attitudes About Sleep Scale(Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline)
研究者
Dr. Chung Ka-Fai
Associate Professor
The University of Hong Kong
研究点 (1)
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