Effects of Nurse-Guided Brief Behavioral Treatment for Insomnia on Sleep, Mood, and Cognition: Model Establishment and Application in Patients at the Recovery Phase Following Traumatic Brain Injury

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 65
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Taiwan
Skin Kong International Health Center
RECRUITING
Taipei
Taipei Medical University
RECRUITING
Taipei
Contact Information
Primary
Hsiao-Yean Chiu, Ass. Professor
hychiu0315@tmu.edu.tw
886-2-27361661
Time Frame
Start Date: 2022-08-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 93
Treatments
Experimental: Nurse-guided BBTi group
Participants will experience 4-week treatment period (2 in person and 2 via telephone).
Experimental: Mobile-delivered BBTi group
Participants will be shown how to download and use the app in their own mobile device after the baseline assessment.
No_intervention: Sleep hygiene control group
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.
Related Therapeutic Areas
Sponsors
Leads: Taipei Medical University

This content was sourced from clinicaltrials.gov

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