Traumatic Brain Injury Clinical Trial
Official title:
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
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.
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. ;
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