About this trial
This study will employ cognitive behavioral therapy for insomnia (CBT-I) among individuals with mild traumatic brain injury (mTBI) who experience sleep disturbances. The research aims to evaluate the effects of CBT-I on sleep, mTBI symptoms, and, in particular, the ability of individuals with mTBI to engage in their desired daily life activities. The main questions this study aims to answer are:
1. Does CBT-I positively impact symptoms of mTBI? 2. Does CBT-I improve functional performance in individuals with mTBI?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A history of mTBI documented by a physician and sleep problems for more than 4 weeks
A score ≥ 10 on the Insomnia Severity Index (ISI)
Speak, read, and write English
Disqualifiers
History of other neurological or psychological conditions
Patient Health Questionnaire-9 (PHQ-9) score higher than 20 (severe depressive symptoms)
Generalized Anxiety Disorder-7 (GAD-7) score higher than 15 (severe anxiety symptoms)
Montreal Cognitive Assessment (MoCA) score less than 24
Trial design
Single group
Treatments tested in this trial
Cognitive behavioral Therapy for insomnia (CBT-I)
BehavioralCBT-I is an evidence-based psychotherapy designed to address insomnia. This structured and multifaceted intervention aims to help individuals who have trouble falling asleep or/ and staying asleep during the night. CBT-I is a multi-component treatment that includes two core parts: behavioral and cognitive aspects. It consists of Sleep Restriction Therapy (SRT), Stimulus Control Therapy (SCT), and Cognitive Therapy (CT) with an emphasis on Cognitive restructuring, as well as Psychoeducation and Sleep Hygiene Education. Each CBT-I session has a clear structure and includes various components such as assessment, psychoeducation, behavioral and cognitive interventions, adherence monitoring, and strategies for preventing relapse. In this study, participants will receive CBT-I in a one-on-one setting, meeting on Zoom once a week for six weeks, and each session will last an hour.
Treatment groups
Trial outcomes
Primary outcomes
The expanded consensus sleep diary (CSD)
The expanded consensus sleep diary (CSD) is intended for use both in the morning and evening. Participants are required to complete the diary each morning upon waking and each evening before bedtime. The evening section records information about daytime activities, including caffeine, alcohol, medication use, and napping. The morning section captures details regarding the previous night's sleep.
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a seven-item questionnaire developed to assess the severity of insomnia symptoms. Scores range from 0 to 28, with higher scores indicating more severe symptoms.
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a sleep questionnaire that evaluates seven primary components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over a one-month period. The PSQI is used to assess the impact of cognitive behavioral therapy for insomnia (CBT-I) on these sleep components. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) is a sleep questionnaire consisting of 8 items that assesses daytime sleepiness. A score of 10 or higher indicates pathological daytime sleepiness. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Secondary outcomes
Dysexecutive Questionnaire (DEX)
The Dysexecutive Questionnaire (DEX) is a self- or informant-reported measure of everyday executive function difficulties, including problems with planning, organization, problem-solving, and behavior regulation. Total scores range from 0 to 80, with higher scores indicating more pronounced executive dysfunction.
Neurobehavioral Symptom Inventory (NSI)
The Neurobehavioral Symptom Inventory (NSI) is a self-reported measure of common mild Traumatic Brain Injury (mTBI) symptoms, including cognitive, affective, sleep, and somatic complaints. Total scores typically range from 0 to 100, with higher scores reflecting greater symptom severity.
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a self-administered instrument designed to evaluate the impact of fatigue on daily functioning. It consists of 9 items, each rated on a scale from 1 to 7, yielding a total score of 9 to 63. Higher average scores reflect greater fatigue severity.
Beck's Depression Inventory (BDI)
The Beck Depression Inventory-II (BDI-II) is a self-reported questionnaire assessing the severity of depressive symptoms over the past two weeks. Total scores range from 0 to 63, with higher scores reflecting more severe depression.
Other outcomes
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a brief cognitive screening tool that assesses multiple cognitive domains including memory, attention, language, visuospatial skills, and executive function. Total scores range from 0 to 30, with higher scores reflecting better overall cognitive performance.
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a self-reported measure assessing the severity of depressive symptoms over the past two weeks. Total scores range from 0 to 27, with higher scores reflecting more severe depression.
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a self-reported questionnaire assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety.
Sponsors and contacts
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