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

BEHAVIORAL

Cognitive behavioral Therapy for insomnia (CBT-I)

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.

The expanded consensus sleep diary (CSD)

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

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)

Time frame: Baseline (Day 1)

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)

Time frame: Baseline (Day 1)

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)

Time frame: Baseline (Day 1)

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.

Canadian Occupation Performance Measure (COPM)

Time frame: Baseline (day 1)

The Canadian Occupation Performance Measure (COPM) is a self-reported measure of an individual's perceived performance and satisfaction in important daily activities. Scores range from 1 (low) to 10 (high) for both performance and satisfaction, with higher scores indicating better outcomes.

Activity Card Sort (ACS)

Time frame: Baseline (day 1)

Occupational therapists use the Activity Card Sort (ACS) to help clients describe their social, instrumental, and leisure activities. For this study, we are going to use Electronic Activity Card Sort. It serves the same purpose as the paper/card version but is administered electronically. Total scores are expressed as a percentage (0-100%), with higher scores indicating greater participation and activity engagement.

Feasibility of Intervention Measure (FIM)

Time frame: Post intervention (final study visit)

Feasibility of Intervention Measure (FIM) is a questionnaire that includes 12 items for evaluating acceptability, feasibility, and appropriateness of the Intervention.

Client Satisfaction Questionnaire (CSQ-8)

Time frame: Post intervention (final study visit)

The Client Satisfaction Questionnaire (CSQ-8) was used to evaluate participant satisfaction with the intervention. Scores range from 8 to 32, with higher scores indicating greater satisfaction with the intervention.

Insomnia Severity Index (ISI)

Time frame: Post intervention (final study visit)

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)

Time frame: Post intervention (final study visit)

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)

Time frame: Post intervention (final study visit)

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.

Canadian Occupation Performance Measure (COPM)

Time frame: Post intervention (final study visit)

The Canadian Occupation Performance Measure (COPM) is a self-reported measure of an individual's perceived performance and satisfaction in important daily activities. Scores range from 1 (low) to 10 (high) for both performance and satisfaction, with higher scores indicating better outcomes.

Activity Card Sort (ACS)

Time frame: Post intervention (final study visit)

Occupational therapists use the Activity Card Sort (ACS) to help clients describe their social, instrumental, and leisure activities. For this study, we are going to use Electronic Activity Card Sort. It serves the same purpose as the paper/card version but is administered electronically. Total scores are expressed as a percentage (0-100%), with higher scores indicating greater participation and activity engagement.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.