Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTaipei Medical University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Nurse-guided BBTi group
BehavioralOn 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
BehavioralThey 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).
Treatment groups
93 Participants
are divided into 3 treatment groupsGroup A: Nurse-guided BBTi groupExperimental treatment 1 intervention
Group B: Mobile-delivered BBTi groupExperimental treatment 1 intervention
Group C: Sleep hygiene control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished2
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.
Time frame
at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished3
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.
Time frame
at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished4
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.
Time frame
at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finishedSecondary outcomes
1
Changes in Depression
Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score\>9 is associated with depression. The higher score means more severe depression.
Time frame
at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished2
Changes in Anxiety
Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score\>7 is associated with anxiety. The higher score means more severe anxiety.
Time frame
at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished3
Changes in Stress
Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score\>14 is associated with anxiety. The higher score means more severe stress.
Time frame
at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished4
Changes in Ruff 2 and 7
The Ruff 2 \& 7 test will be used to test sustained and selective aspects of visual attention. It consists of 20 trials (10 Automatic Detection trials and 10 Controlled Search trials), with three line per trial, administered consecutively in 15-s intervals, working from left to right. The Automatic Detection and Controlled Search scores will used to assess selective attention. Sustained attention is measured primarily by the Total Speed (number of correctly identified targets during the allotted 5-min duration), and Total Accuracy (number of targets identified during the 5-min duration divided by the number of possible targets) scores.
Time frame
at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finishedSponsors and contacts
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Source ClinicalTrials.gov