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

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults who had a traumatic brain injury at least 3 months ago and now have insomnia (trouble sleeping).

Életkor

20 Years to 65 Years

Nem

All sexes can join.

A betegség stádiuma

Brain injury diagnosed at least 3 months before joining (chronic stage). First GCS score in the emergency room of 3-15 (mild to severe), and GCS score of 15 at joining. Lying awake ≥30 min a night, ≥3 nights per week, for ≥3 months.

Biomarker vagy leletérték

Insomnia score above 7 on the Chinese version of the insomnia severity scale (CISI). Rancho Los Amigos cognitive scale score above 9. Must speak Mandarin Chinese and be able to do thinking tasks.

A részvétel fő kizáró okai

• Seizures diagnosed before the injury
• Other sleep disorders, such as sleep apnea (STOP-Bang score above 3)
• Psychiatric diseases, substance abuse or alcoholism
• Shift workers
• Women who are pregnant, breastfeeding, or going through menopause

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 20 és 65 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 3 csoportja

• Nurse-guided BBTi groupA vizsgált kezelés

  Participants will experience 4-week treatment period (2 in person and 2 via telephone).

• Mobile-delivered BBTi groupA vizsgált kezelés

  Participants will be shown how to download and use the app in their own mobile device after the baseline assessment.

• Sleep hygiene control groupNincs vizsgálati kezelés, összehasonlításként

  Participants will receive sleep hygiene at the enrollment of the study and be required to maintain their usual lifestyle and medical treatment for 4 weeks.