Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury

Condition(s) studied

Investigational drug(s) / intervention(s)

Nurse-guided BBTi group: On the arrival for the baseline appointment, participants will receive workbooks which include an outline and content of BBTi. In the end of week 1 and 3, nurse interventionist will meet participants to review their sleep diary data and negotiate their bedtime and wake-time schedule. During the weeks 2 and 4, participants will receive planned follow-up phone calls to assess their adherence and review progress and challenges.

Mobile-delivered BBTi group: They will use the app in conjunction with the standard BBTi procedures provided by the app, such as stimulus control, sleep restriction and audio-guided relaxation techniques (suggest to use before bedtime).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Changes in Insomnia Severity — 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.
• Changes in Sleep quality — 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 Daytime Sleepiness — 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 parameters from sleep logs: sleep onset latency(SOL) — 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 Sleep parameters from sleep logs: after sleep onset(WASO) — 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: total sleep time(TST) — 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 efficiency(SE) — 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%.

Trial sites (2)

More Taipei Medical University trials in Taiwan

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