Effectiveness and Cost-effectiveness of iCBT-I in Clinical Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 3
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The proposed parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition will let us investigate the effectiveness and cost-effectiveness of iCBT-I. Analysis of baseline characteristics of the participants aims to find predictors of outcome
详细描述
Application of internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) is a perspective method that can fill the gap created by the discrepancy between insomnia cases and the number of trained professionals. Although the effectiveness of this method was proven in multiple studies conducted in research settings, it is unclear if iCBT-I outperforms pharmacotherapy which remains a widely used alternative of cognitive-behavior therapy of insomnia (CBT-I). Predictors, mediators, and moderators of treatment effect remain uncertain since previous studies often give contradictory results. The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual (CAU) among patients with chronic insomnia (CI) recruited from clinical settings. Baseline data will be further analyzed to find predictors of treatment outcome
For these purposes, a parallel-group randomized controlled trial add-on superiority of the iCBT-I program with CAU as a control condition was designed. 110 participants will be referred from the medical doctors in Moscow. Both groups will have access to CAU, treatment prescribed by the referred doctor. Patients of the first group will additionally get access to the iCBT-I program with the opportunity to contact a specialist within the program (guidance on request) in a secured environment. The primary outcome is insomnia severity change from pre- to posttreatment and to post-follow-up. Secondary outcomes include change subjective sleep characteristics, daytime symptoms, comorbid affective disorders, dysfunctional cognitions and behavior, healthcare consumption, and productivity losses. Predictors analysis will include baseline scores of the aforementioned outcomes along with treatment expectancies, personality traits
To the best of our knowledge, the present study is the first study of iCBT-I to be conducted in clinical settings. We expect that this approach lets us determine the target group more precisely and exclude health problems that may interfere with treatment. It is also expected that patients, referred to iCBT-I from the doctor's office will be more motivated to finish the treatment course that will reduce the drop out rate. CAU as control condition let us reconstruct clinical situation facing practicing doctor. On the other hand, CAU may result in a loss of power to detect a meaningful difference. Limitation of our study is in the impossibility of blinding participants to the treatment condition
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sleep disorder matching chronic insomnia criteria (International Classification of Sleep Disorders-3) - assessed by clinical judgement
- •Ability to follow the procedures of the study, fluent Russian language, Good access to internet - assessed by self-report
排除标准
- •Presence of dementia (identified by history or a score < 25 on the Folstein Mini Mental Status Exam) - assessed by clinical judgement
- •Severe depression or severe anxiety as measured with the Beck Depression Inventory (BDI-II; score > 28 ) and the Beck Anxiety Inventory (BAI; score > 26) - assessed by the questionnaires
- •History of severe psychiatric comorbidities other than anxiety and depression (bipolar disorders, psychotic disorders) or substance use disorder - assessed by self-report and clinical history
- •Untreated severe obstructive sleep apnea syndrome (apnea-hypopnea index (AHI) > 15), restless legs syndrome (movement index with arousal > 15 per hour) or other sleep disorders affecting night sleep - assessed by clinical judgement and clinical history
- •pregnancy, lactation - assessed by self-report
- •having a serious somatic condition or brain disorders (stroke, Parkinson's disease…) preventing further participation - assessed by self-report
- •Having high suicidality risk - assessed by clinical judgement, high total BDI-II score (> 29) or score >1 on a BDI-II of suicidality subscale
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: pre- to post-treatment 2 months, pre-treatment to follow-up 5 months
Change of ISI from pre- to post-treatment and post-follow-up. Change is calculated as the value at the earlier time point minus the value at the later time point. Positive values correspond to the better outcome, negative values correspond to the worse outcome, i.e. increase of insomnia severity. The ISI is a seven-item insomnia assessment tool. The 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28)
次要结局
- System Usability Scale (SUS)(After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)
- Sleep Onset Latency (SOL),(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Total Sleep Time (TST)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Sleep Hygiene Index (SHI)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Health Care Consumption(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Sleep Efficiency (SE)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Fatigue Severity Scale (FSS)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Beck Depression Inventory (BDI-II)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Wake After Sleep Onset (WASO)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Short-form Survey (SF-12 Version 1.0)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Epworth Sleepiness Scale (ESS)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Beck Anxiety Inventory (BAI)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Sleep Locus of Control Questionnaire (SLC)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Anxiousness Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Time Spent on Each Module(After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)
- Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Success Expectancy(Once at baseline assessment)
- Trimbos Questionnaire for Costs Associated With Psychiatric Illness (TiC-P) Short Form- Health and Labour Questionnaire (SF-HLQ)(pre- to post-treatment 2 months, pre-treatment to follow-up 5 months)
- Total Time Spent on the iCBT-I Website(After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)
- Number of Completed Sleep Diaries(After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)
- Attention Seeking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- User Satisfaction(After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)
- Depressivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Emotional Lability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- System Usability Scale (SUS)(After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)
- Usage of the Support(After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)
- Number of Completed Modules(After completion of iCBT-I course: week 8 after randomization for arm iCBT-I +CAU; week 28 after randomization for arm CAU)
- Callousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Deceitfulness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Distractability From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Intimacy Avoidance From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Eccentricity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Grandiosity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Hostility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Impulsivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Irresponsibility From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Unusual Beliefs Experience From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Manipulativeness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Perceptual Dysregulation From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Perseveration From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Restricted Affectivity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Rigid Perfectionism From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Separation Insecurity From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Risk Taking From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Submissiveness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Suspiciousness From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Anhedonia From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
- Withdrawal From Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) Predictive Effect on ISI Improvement(Once at baseline assessment)
研究者
Poluektov Mikhail Gur'evich
Assoc.prof, Dr.
I.M. Sechenov First Moscow State Medical University