Novel Methods to Increase Access and Facilitate Cognitive-behavioral Therapy for Insomnia in the Context of Depression: A Parallel-group Randomized Trial Comparing the Sleep Restriction Component Informed by Electroencephalography Measures to Sleep Restriction Based on Subjective Sleep Measures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Satisfaction with treatment effectiveness as measured with the Modified Treatment Satisfaction Questionnaire for Medication
研究概览
简要总结
This study aims to better adapt cognitive behavioral therapy for insomnia (CBTi) for people with comorbid depression by using objective sleep measures to tailor the behavioral interventions components of CBTi. Using ambulatory monitors, we also aim to investigate changes in brain activity and heart rate throughout the intervention. In this parallel-group randomized clinical trial, participants undergo one week of baseline ambulatory monitoring after which they are randomly assigned to one of two intervention arms: 1) digitally delivered CBTi (eCBTi) based on standard subjective sleep measures (sleep diary), or 2) eCBTi based on objective sleep measures (EEG headband). The intervention spans over 5-weeks, followed by a week of ambulatory monitoring and follow-up measures one week and one month after the end of the intervention. The study also includes a post-intervention interview to gather feedback on participant experiences. The overall protocol includes online questionnaires and structured clinical interviews assessing sleep, insomnia, and mental health, as well as treatment-related measures before, during, and after the intervention. It is anticipated that eCBTi using objective sleep measures will lead to better treatment acceptability, satisfaction, and effectiveness, including greater improvements in symptoms of insomnia and depression. It is also anticipated that sleep EEG and heart rate profiles will improve along the course of eCBTi.
详细描述
- Background
Insomnia is a major public health burden that disproportionately affects individuals with depression. Sleep disturbances are present in approximately 80-90% of cases of depression and are associated with more severe depressive symptoms, a less favorable prognosis, more medical and psychiatric comorbidities and a lower quality of life. Physiological hyperarousal, an abnormal state of increased responsiveness to stimuli marked by various physiological and psychological symptoms, is one of the pathophysiological mechanisms common to insomnia and depression. This state of hyperarousal is perceptible at the level of cortical activation and heart rate (HR) during sleep. Considering this overlapping of underlying mechanisms, intervening with sleep represents a promising way to simultaneously target cortical and cardiac hyperarousal, insomnia, and mood.
CBTi is the recommended first line of treatment for chronic insomnia and is associated with significant improvement in depressive symptoms. CBTi is a multicomponent cognitive and behavioral treatment that targets the maladaptive thoughts and behaviors associated with the maintenance of insomnia. It includes five distinct intervention components, namely sleep hygiene education, cognitive therapy, relaxation training, stimulus control, and sleep restriction therapy.
Sleep restriction therapy is one of the central components of CBTi which aims to restrict the time spent in bed according to a specific time window. This window is determined from the individual's sleep diary which is a subjective measure of sleep. As sleep estimation is particularly biased in those with insomnia and a depressive comorbidity, the use of sleep diaries is likely to increase stress and treatment-related burden as well as limit the accuracy of CBTi sleep manipulations. Another important limitation of CBTi in the context of psychiatric comorbidities is the high demand for this type of treatment in clinical settings coupled with the lack of trained clinicians which considerably restricts accessibility. The emergence of accurate ambulatory sleep monitors and of effective digitally delivered CBTi thus represents a new opportunity to increase access to CBTi, to anchor sleep restriction therapy on objective sleep measures and to observe changes happening at a physiological-level during treatment.
To date, few studies have investigated the practical implications of wearable devices and digital technology in behavioral sleep medicine, especially with clinical populations. As highlighted in a recent systematic review, there is now a need to investigate whether the use of objective sleep data has the possibility to enhance the therapeutic outcomes associated with behavioral sleep interventions. A large clinical trial comparing treatment outcomes in users and non-users of wearable devices completing an eCBTi program showed similar treatment effects on insomnia symptoms. The authors concluded that the use of wearables may facilitate treatment for individuals who may have a difficult time completing daily sleep diaries. This has yet to be investigated in individuals with depression for whom sleep estimation represents an important struggle. 2. Objectives
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 (Care Provider, Outcomes Assessor)
盲法说明
All researchers involved in clinical assessments or data processing will be blinded to the assignment of these different conditions. Participants will be asked not to discuss the modality of sleep measurements (Sleep diary or EEG headband) with the research staff or their care provider.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 65 years old
- •Asymptomatic on the Sleep Disorders Symptoms Checklist-25 (except for insomnia)
- •Symptomatic on the Sleep Condition Indicator (i.e. score above <3 on specific combination of items
- •Current diagnosis of major depressive disorder or persistent depressive disorder confirmed by the Patient Health Questionnaire (PHQ-9) score > 10 and the MDE scale of the Mini International Neuropsychiatric Interview (M.I.N.I.)
- •Having a smartphone and willingness to install a sleep intervention application on it
排除标准
- •Current diagnosis of bipolar disorder, psychotic disorder or post-traumatic stress disorder confirmed by the M.I.N.I.
- •Brain injury with loss of consciousness for over 5 minutes
- •Self-reported substance use disorder (i.e. alcohol, cannabis, or illicit drugs) or > monthly use of illicit drugs reported on item-2 of the WHO Alcohol, Smoking and Substance Involvement Screening Test (except tobacco, alcohol, and cannabis)
- •Body mass index > 45
- •Shift work or rotating shifts within 1 month of study entry
- •Recent travel to a difference time zone
- •Any clinically significant cardiopulmonary, gastrointestinal, pancreatic, hepatic, renal, hematologic, endocrine, neurological (including seizure disorder), or sleep disorder (other than insomnia)
- •Taking any psychotropic medications p.r.n. (If taking any antidepressant or sleep medications, needs to be on a stable dose for at least 1 month prior to study start).
- •Taking stimulant medications including, but not limited to, Adderall, Concerta, Ritalin, Desoxyn, Dexedrine, Dextrostat, Ephedrine, Phentermine, Procentra, Vyvanse, and Selegline
- •Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires
- •Individuals with mini-braids, dreadlocks, hair extension or natural afro-hair that can alter the EEG headband recording
结局指标
主要结局
Satisfaction with treatment effectiveness as measured with the Modified Treatment Satisfaction Questionnaire for Medication
时间窗: 7 weeks
Satisfaction with treatment effectiveness, side effects, and convenience as rated on the Modified Treatment Satisfaction Questionnaire for Medication (mTQSM). The TQSM is a 14-item self-report scale with total scores ranging from 14-98, higher scores indicating greater treatment satisfaction. This questionnaire has been adapted for the purpose of this study: the term "medication" has been replaced by "intervention", and the term "condition" had been replaced by "symptoms of insomnia or depression".
Treatment acceptability as measured by the Treatment Acceptability/Adherence Scale
时间窗: 7 weeks
Adherence to CBT-I guidelines and perceived helpfulness of treatment guidelines as rated on the Treatment Acceptability/Adherence Scale (TAAS). The TAAS is a 10-item questionnaire with total scores ranging from 10-70, higher scores indicating greater treatment acceptability and adherence.
次要结局
- Changes in insomnia symptoms(From pre-intervention (week 0) to the last follow-up (week 10))
- Changes in EEG-based sleep latency(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in EEG-based slow wave activity(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in unhelpful beliefs about sleep(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in subjective fatigue(From pre-intervention (week 0) to the last follow-up (week 10))
- Changes in EEG-based slow wave sleep(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in subjective sleep quality(From pre-intervention (week 0) to the last follow-up (week 10))
- Changes in subjective pre-sleep arousal(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in clinician-assessed depression symptoms assessed with the Hamilton Depression Rating Scale(From pre-intervention (week 0) to the last follow-up (week 10))
- Treatment acceptability as indexed by the number of drop outs(7 weeks)
- Satisfaction with treatment effectiveness as measured by the Modified Treatment Satisfaction Scale(7 weeks)
- Changes in EEG-based total sleep time(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in heart rate(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in self-reported depression symptoms rated on the Quick Inventory of Depressive Symptomatology (QIDS). The QIDS is a 16-item questionnaire with total scores ranging from 0 to 27, with higher scores indicating greater depressive severity.(From pre-intervention (week 0) to the last follow-up (week 10))
- Objective-subjective discrepancy in sleep latency(1 week)
- Objective-subjective discrepancy in total sleep time(1 week)
- Changes in self-reported anxiety symptoms rated on the Depression, Anxiety and Stress Scale(From pre-intervention (week 0) to the last follow-up (week 10))
- EEG-Actigraphy discrepancy in sleep latency(1 week)
- EEG-Actigraphy discrepancy in total sleep time(1 week)
- Qualitative feedback(7 weeks)
- Changes in EEG power spectra(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in EEG-based slow wave morphometrics(From pre-intervention (week 0) to post-intervention (week 7))
- Changes in self-reported stress symptoms rated on the Depression, Anxiety and Stress Scale(From pre-intervention (week 0) to the last follow-up (week 10))
- Objective-subjective discrepancy in sleep efficiency(1 week)
- Changes in self-reported depression symptoms rated on the Depression, Anxiety and Stress Scale(From pre-intervention (week 0) to the last follow-up (week 10))
- EEG-Actigraphy discrepancy in sleep efficiency(1 week)
研究者
Rébecca Robillard
Assistant Professor
University of Ottawa