Effects of Nurse-Guided Brief Behavioral Treatment for Insomnia on Sleep, Mood, and Cognition: Model Establishment and Application in Patients at the Recovery Phase Following Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- Changes in Sleep parameters from sleep logs: total sleep time(TST)
研究概览
简要总结
nsomnia is a frequent complaint reported by patients with TBI, and exacerbates their ability to return to productive activity, which subsequently elevate related healthcare costs and burden. Existing literatures found that effects of CBTi, first-line therapy for insomnia, on post-traumatic insomnia is still debated, indicating that developing an alternative nonpharmacological therapy for alleviating insomnia following TBI is required. Besides, digital health is one of strategies to achieve precision health. Thus far, knowledge regarding whether mobile-delivered BBTi has non-inferiority effects as BBTi in treating insomnia is still lacking. Therefore, a RCT with a large sample size to examine the immediate and lasting effects of BBTi and mobile-delivered BBTi on insomnia, mood disturbances, and cognitive dysfunctions in patients following TBI at the recovery stage compared with the control participants.
详细描述
Background: Insomnia is highly prevalent in adults with traumatic brain injury (TBI), which in turn undermine their mood, cognitive functions, and quality of life. However, an effective non-pharmacological intervention for managing insomnia in this population is still lacking. Nurses, the first-line healthcare providers, should therefore seek an approach for managing post-TBI sleep. Brief behavioral treatment for insomnia (BBTi) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been applied in people with neurological deficits such as TBI.
Purposes: To establish the BBTi treatment model among insomniacs in Taiwan, and to examine the immediate and lasting effects of nurse-guided BBTi and mobile-delivered BBTi on sleep, mood, and cognitive functions in adults with TBI. We hypothesize that people with TBI undergoing nurse-guided BBTi and mobile-delivered BBTi will experience greater alleviations in insomnia, mood disturbances, and cognitive dysfunctions in comparison with participants in the sleep hygiene control group.
Methods: This 3-year, assessor-blinded randomized controlled trial will employ a three-arm parallel-group design. A total of 228 TBI survivors with insomnia complaints will be randomly allocated to the nurse-guided BBTi, mobile-delivered BBTi, or sleep hygiene control group in a 1:1:1 ratio. For the nurse-guided BBTi group, all participants will experience 4-week-long BBTi via 2 in person and 2 telephone sessions. For the mobile-delivered BBTi, participants will use the apps in conjunction with the standard BBTi procedures provided by the functions of apps: "Sleep Aids" and "Relaxation therapy". For the sleep hygiene control group, they will receive usual care and sleep hygiene education. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Epworth sleepiness scale, Chinese version of Pittsburgh sleep quality index, and 7-day actigraphy with a sleep diary. Secondary outcomes consist of mood and cognitive functions assessed using The Depression, Anxiety and Stress Scale - 21 Items, Ruff 2 & 7 test, Rey Auditory Verbal Learning Test, and Symbol Digit Modalities Test.
Questionnaires and actigraphy will be assessed in pretreatment, posttreatment, and the 6th and 12th months after treatment. A generalized estimating equation will be used to test research hypotheses.
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)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have received a diagnosis of TBI at least 3 months before enrollment (TBI in chronic stage),
- •yield an initial (i.e., rated in the emergency room) GCS score of 3-15 (mild to severe) and have GCS score of 15 when enrolling into the study,
- •report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months,
- •have post-TBI insomnia with a total score > 7 on the Chinese version of the insomnia severity scale (CISI) at screening,
- •be able to communicate in Mandarin Chinese, and be able to complete cognitive tasks (having Rancho Los Amigos Levels of Cognitive Functioning scale score > 9)
排除标准
- •include premorbid diagnoses of seizure,
- •sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score > 3),
- •psychiatric diseases,
- •substance abuse,
- •alcoholism
- •Shift workers and women who are pregnant, breastfeeding, or in the menopausal transition
结局指标
主要结局
Changes in Sleep parameters from sleep logs: total sleep time(TST)
时间窗: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
时间窗: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Changes in Daytime Sleepiness
时间窗: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Daytime Sleepiness will be measured by Epworth Sleepiness Scale (ESS). ESS has 8 questions to evaluate the condition of dozing off or falling asleep. The score range from 0-24, if score\>10 is associated with daytime sleepiness.
Changes in Sleep quality
时间窗: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score\>5 is associated with poor sleep. The higher score means poorer sleep quality.
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
时间窗: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
时间窗: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
Changes in Insomnia Severity
时间窗: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of \> 7 is used to diagnose subthreshold insomnia.
次要结局
- Changes in Stress(at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished)
- Changes in Anxiety(at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished)
- Changes in Rey Auditory Verbal Learning Test (RAVLT)(at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished)
- Changes in Symbol digital modalities(at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished)
- Changes in Depression(at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished)
- Changes in Ruff 2 and 7(at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished)
研究者
Hsiao-Yean Chiu
Principal Investigator
Taipei Medical University