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

NCT05402761 | Recruiting

• 1 other identifier: N202104039
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

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.

Conditions

Insomnia; Traumatic Brain Injury

Keywords

Insominia; BBTi; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (7)

• Changes in Insomnia Severity

  The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of \> 7 is used to diagnose subthreshold insomnia.

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Sleep quality

  Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score\>5 is associated with poor sleep. The higher score means poorer sleep quality.

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Daytime Sleepiness

  Daytime Sleepiness will be measured by Epworth Sleepiness Scale (ESS). ESS has 8 questions to evaluate the condition of dozing off or falling asleep. The score range from 0-24, if score\>10 is associated with daytime sleepiness.

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)

  Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Sleep parameters from sleep logs: after sleep onset(WASO)

  Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Sleep parameters from sleep logs: total sleep time(TST)

  Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Sleep parameters from sleep logs: sleep efficiency(SE)

  Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

Secondary Outcomes (6)

• Changes in Depression

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Anxiety

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Stress

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Ruff 2 and 7

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

• Changes in Rey Auditory Verbal Learning Test (RAVLT)

  at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished

Study Arms (3)

Nurse-guided BBTi group

EXPERIMENTAL

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

Behavioral: Nurse-guided BBTi group

Mobile-delivered BBTi group

EXPERIMENTAL

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

Behavioral: Mobile-delivered BBTi group

Sleep hygiene control group

NO INTERVENTION

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.

Interventions

Nurse-guided BBTi group BEHAVIORAL

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.

Nurse-guided BBTi group

Mobile-delivered BBTi group BEHAVIORAL

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).

Mobile-delivered BBTi group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (2)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

Skin Kong International Health Center

Taipei, 111, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Hsiao-Yean Chiu, Ass. Professor

CONTACT

886-2-27361661; hychiu0315@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: June 2, 2022
• Study Start: August 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

TW (2)