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

NCT05402761 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2026-03-31

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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).

Sponsors & Collaborators

  • Taipei Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05402761 on ClinicalTrials.gov