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

NCT ID: NCT05402761

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2026-12-31

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.

Conditions

Insomnia; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nurse-guided BBTi group

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

Group Type: EXPERIMENTAL

Nurse-guided BBTi group

Intervention Type: 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.

Mobile-delivered BBTi group

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

Group Type: EXPERIMENTAL

Mobile-delivered BBTi group

Intervention Type: 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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse-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.

Intervention Type: BEHAVIORAL

Mobile-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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Yean Chiu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Medical University

Taipei, , Taiwan

Site Status: RECRUITING

Skin Kong International Health Center

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsiao-Yean Chiu, Ass. Professor

Role: CONTACT

hychiu0315@tmu.edu.tw

886-2-27361661 ext. 6329

Facility Contacts

Hisao Yean Chiu, PhD

Role: primary

hychiu0315@tmu.edu.tw

886227361661 ext. 6329

Ta-Wei Wang, Dr

Role: primary

davie71722@gmail.com

0954040283

Other Identifiers

N202104039

Identifier Type: -

Identifier Source: org_study_id