Clinical trial NCT05402761: Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Traumatic Brain Injury
Keywords: Insominia
BBTi
Traumatic Brain Injury
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Background: Insomnia is highly prevalent in adults with traumatic brain injury (TBI), which in turn undermine their mood, cognitive functions, and quality of life. However, an effective non-pharmacological intervention for managing insomnia in this population is still lacking. Nurses, the first-line healthcare providers, should therefore seek an approach for managing post-TBI sleep. Brief behavioral treatment for insomnia (BBTi) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been applied in people with neurological deficits such as TBI.

Purposes: To establish the BBTi treatment model among insomniacs in Taiwan, and to examine the immediate and lasting effects of nurse-guided BBTi and mobile-delivered BBTi on sleep, mood, and cognitive functions in adults with TBI. We hypothesize that people with TBI undergoing nurse-guided BBTi and mobile-delivered BBTi will experience greater alleviations in insomnia, mood disturbances, and cognitive dysfunctions in comparison with participants in the sleep hygiene control group.

Methods: This 3-year, assessor-blinded randomized controlled trial will employ a three-arm parallel-group design. A total of 228 TBI survivors with insomnia complaints will be randomly allocated to the nurse-guided BBTi, mobile-delivered BBTi, or sleep hygiene control group in a 1:1:1 ratio. For the nurse-guided BBTi group, all participants will experience 4-week-long BBTi via 2 in person and 2 telephone sessions. For the mobile-delivered BBTi, participants will use the apps in conjunction with the standard BBTi procedures provided by the functions of apps: "Sleep Aids" and "Relaxation therapy". For the sleep hygiene control group, they will receive usual care and sleep hygiene education. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Epworth sleepiness scale, Chinese version of Pittsburgh sleep quality index, and 7-day actigraphy with a sleep diary. Secondary outcomes consist of mood and cognitive functions assessed using The Depression, Anxiety and Stress Scale - 21 Items, Ruff 2 \& 7 test, Rey Auditory Verbal Learning Test, and Symbol Digit Modalities Test.

Questionnaires and actigraphy will be assessed in pretreatment, posttreatment, and the 6th and 12th months after treatment. A generalized estimating equation will be used to test research hypotheses.

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

Primary outcomes:
measure: Changes in Insomnia Severity
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Sleep quality
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Daytime Sleepiness
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Sleep parameters from sleep logs: total sleep time(TST)
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Secondary outcomes:
measure: Changes in Depression
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Anxiety
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Stress
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Ruff 2 and 7
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
measure: Changes in Symbol digital modalities
timeFrame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: Skin Kong International Health Center
Study officials:
References: