A Randomized Controlled Study of E-aid Cognitive Behavior Therapy in Patients With Acute Insomnia to Prevent Transition to Chronic Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Incidence of chronic insomnia
研究概览
简要总结
Acute insomnia is one of the most common sleep disorders. Online cognitive behavioral therapy for insomnia (e-aid Cognitive Behavioral Therapy for Insomnia, eCBTI) has received wide attention in recent years. Foreign countries already have some eCBTI treatment tool, shown similar efficacy as standard CBTI, but how eCBTI can help in acute insomnia require further exploration and examination.
In this study, Investigators will establish eCBTI treatment tool to test whether eCBTI can reduce the conversion of acute insomnia to chronic insomnia disorder; and whether they can improve insomnia symptoms, sleep-related symptoms, anxiety and depressive symptoms, and quality of life
详细描述
Insomnia patients are collected from: Outpatients from Sleep clinics. Included 200 cases of acute insomnia patients, the participants will randomly divided into 100 brief eCBTI Group and 100 patients with control group, brief eCBTI Group will receive 1 Week eCBTI intervention and control group will not receive any intervention. Both groups will receive 3 months of follow-up.
At week 2, ISI and HADS will be conducted. Brief eCBTI group will also complete Treatment Component Adherence Scale (TCAS) in order to assess treatment adherence to and perceived helpfulness of each therapeutic element. At 3 months, two groups of subjects will have baseline assessment(except socio-demographic information), including chronic insomnia disorder diagnosis and self evaluation form (ISI, DBAS, SHPS ,PSAS,FIRST,ESS,HADS,SF-12v2).
This study provides a Smartphone to complete third-party applications online insomnia treatment procedures. Brief eCBTI includes 1-week core curriculum: sleep hygiene education, sleep restriction, stimulus control, relaxation audios, cognitive components, information about sleeping pills, and a brief overview.
Previous studies have shown that approximately 40% of acute insomnia will turn into Chronic insomnia disorder.While our preliminary work suggests, with the extension of follow-up time, high rates of chronic insomnia may be more ( 52.3% ).In order to meet the 95% confidence intervals (Confidence Interval, CI )( 35%-49% ) requirement, the project needs 200 acute insomnia disorder subjects, and random access eCBTI Treatment group and the control group (100 Cases) of whom an estimated 70% or more participants can complete 3 months of follow-up. This sample size ensures continuous data of small sample (Cohen d = 0.30) statistical effect is greater than 0.8, And test the odds ratio of dichotomous variables (Odds Ratio, OR) greater than 1.50(p>0.05 ).
Mean value for continuous variable data ± Standard deviation, Numerical or categorical variable data expressed as a percentage. T test for the continuous variables and Chi Square test for the categorical variables will be used. Using repeated measures analysis of variance to compare two sets of continuous variables in the treatment and follow-up of changes in the process (such as ISI score, etc). Incidence of chronic insomnia is computed using Chi Square test. All statistical procedures are used in Windows running 26.0 version of the SPSS package (IBM SPSS 26.0).
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 (Outcomes Assessor)
盲法说明
The independent researcher from the IT department who carries out the randomisation and allocation procedure will be blinded to the study protocol. Participants could not be blinded to treatment allocation as participants in the control group did not receive any intervention from this trial. The research team will have limited contact with both IT staff and study participants, therefore, will not be able to bias the allocation or the assessments. Statistical analyses will be carried out by an independent researcher from the Southern Medical University who is not involved with the randomisation and assessment procedures.
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
- •Clinical diagnosis for acute insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- •Must be eighteen years or older;
- •Must be able to comply with the intervention;
- •Must be able to provide informed consent;
- •Owning smart devices (such as smartphones and tablets).
排除标准
- •A significant untreated mental or medical illness (e.g. consciousness disturbances, mania, acute phase of schizophrenia, major depressive disorder);
- •Received any kind of psychological treatment for insomnia in the past 6 months;
- •Shift workers, frequent cross-time flyers (e.g. shifted nurse/health professionals, international flight crew).
- •To allow for greater generalisability, this study does not exclude patients with a stable condition of somatic disease, mental disorders (eg, depression in remission), or individuals receiving pharmacological treatments (eg, antihypertensive drugs, antidepressants and benzodiazepines).
结局指标
主要结局
Incidence of chronic insomnia
时间窗: 3 months
the diagnostic criteria for chronic insomnia disorder according to DSM-5
次要结局
- Changes in Ford Insomnia Response to Stress Test (FIRST)(baseline and 3 months)
- Changes in Short Form 12-Item Health Survey version 2（SF-12v2）(baseline and 3 months)
- Changes in Pre-Sleep Arousal Scale(PSAS)(baseline and 3 months)
- Changes in Epworth Sleepiness Scale(ESS)(baseline and 3 months)
- Changes in Hospital Anxiety and Depression Scale (HADS)(baseline, week 2, and 3 months)
- Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)(baseline and 3 months)
- Changes in Insomnia Severity Index(ISI)(baseline，week 2, and 3 months)
- Changes in Sleep Hygiene and Practices Scale(SHPS)(baseline and 3 months)
- Treatment Component Adherence Scale (TCAS)(week 2)