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

RecruitingNAAges 20 Years - 65 YearsAllTaipei Medical University
NCT05402761 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 contro

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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
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What it tests

  • Nurse-guided BBTi group
  • Mobile-delivered BBTi group
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Where

2 sites
Taipei Medical University
Taipei, Taiwan
Skin Kong International Health Center
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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