Actively Recruiting
Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
Led by Taipei Medical University · Updated on 2026-03-31
93
Participants Needed
2
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have received a diagnosis of traumatic brain injury at least 3 months before enrollment
- Had an initial Glasgow Coma Scale (GCS) score of 3-15 and a GCS score of 15 at enrollment
- Experience lying awake for 30 or more minutes at night for at least 3 nights per week for 3 months or longer
- Have post-TBI insomnia with an insomnia severity scale score greater than 7 at screening
- Are able to communicate in Mandarin Chinese and complete cognitive tasks with a Rancho Los Amigos cognitive functioning score above 9
You will not qualify if you...
- Have premorbid diagnoses of seizure
- Have other sleep disorders such as sleep apnea with a STOP-Bang questionnaire score above 3
- Have psychiatric diseases
- Have substance abuse or alcoholism
- Are shift workers
- Are women who are pregnant, breastfeeding, or in menopausal transition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Taipei Medical University
Taipei, Taiwan, 110
Actively Recruiting
2
Skin Kong International Health Center
Taipei, Taiwan, 111
Actively Recruiting
Research Team
H
Hsiao-Yean Chiu, Ass. Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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