Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTaipei Medical University
About this trial
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 criteria
Qualifiers
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,
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Nurse-guided BBTi group
- Mobile-delivered BBTi group
Treatment groups
93 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov