RecruitingNot ApplicableNCT05402761

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

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

Sponsor

Taipei Medical University

Enrollment

93 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

Insomnia Traumatic Brain Injury

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

Min Age: 20 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria6

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

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Interventions

BEHAVIORALNurse-guided BBTi group

On the arrival for the baseline appointment, participants will receive workbooks which include an outline and content of BBTi. In the end of week 1 and 3, nurse interventionist will meet participants to review their sleep diary data and negotiate their bedtime and wake-time schedule. During the weeks 2 and 4, participants will receive planned follow-up phone calls to assess their adherence and review progress and challenges.

BEHAVIORALMobile-delivered BBTi group

They will use the app in conjunction with the standard BBTi procedures provided by the app, such as stimulus control, sleep restriction and audio-guided relaxation techniques (suggest to use before bedtime).