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

Launched by TAIPEI MEDICAL UNIVERSITY · May 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a nurse-guided program called BBTi can help improve sleep problems, known as insomnia, in people recovering from a traumatic brain injury (TBI). Insomnia is common among TBI patients and can make it harder for them to return to daily activities. The trial aims to compare the effects of the traditional BBTi treatment with a mobile version delivered through a smartphone app to see if either can help improve sleep, mood, and thinking skills.

To participate, individuals must have been diagnosed with TBI at least three months prior and currently experience difficulty sleeping for at least three nights a week. They also need to be able to speak Mandarin and complete simple cognitive tasks. Unfortunately, individuals with certain conditions, such as severe sleep disorders or psychiatric issues, or those who are pregnant or breastfeeding, cannot participate. If you join the study, you can expect to work with a nurse and receive support to help improve your sleep and overall well-being.

Gender

ALL

Eligibility criteria

• 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