Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Missouri-Columbia

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Cognitive behavioral Therapy for insomnia (CBT-I)

    Behavioral

    CBT-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

15 Participants
are divided into 1 treatment group
Group A: 15 mTBI cases who have sleep problems will receive CBT-IExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 10 weeks.
2

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.

Time frame
Baseline (Day 1)
3

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.

Time frame
Baseline (Day 1)
4

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.

Time frame
Baseline (Day 1)

Secondary outcomes

1

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.

Time frame
Baseline (day 1)
2

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.

Time frame
Baseline (day 1)
3

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.

Time frame
Baseline (day 1)
4

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.

Time frame
Baseline (day 1)

Other outcomes

1

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.

Time frame
The instrument will be used to assess the study's eligibility and inclusion/exclusion criteria prior to study initiation.
2

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.

Time frame
The instrument will be used to assess the study's eligibility and inclusion/exclusion criteria prior to study initiation.
3

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.

Time frame
The instrument will be used to assess the study's eligibility and inclusion/exclusion criteria prior to study initiation.

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