Sleep ArchitectureNCT07385105
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
A study testing Cognitive behavioral Therapy for insomnia (CBT-I) in people with Sleep Architecture and Mild Traumatic Brain Injury, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sleep Architecture, Mild Traumatic Brain Injury, Sleep
- What is being tested?
- Cognitive behavioral Therapy for insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri-Columbia
Columbia, Missouri, 65211
Sepideh Zenoozi, MSOT, 573-823-3082, sznmx@missouri.edu
About this study
Official title: Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)
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:
- Does CBT-I positively impact symptoms of mTBI?
- Does CBT-I improve functional performance in individuals with mTBI?
Read the detailed description
Cognitive behavioral therapy for insomnia (CBT-I) is an evidence-based intervention that has demonstrated significant results in various populations. CBT-I is a structured and goal-oriented approach that addresses both unhelpful thoughts and maladaptive behaviors contributing to poor sleep. CBT-I includes several components, such as behavioral strategies that aim to change habits disrupting sleep architecture and cognitive techniques targeting maladaptive beliefs about sleep. However, limited research has examined the use of this intervention among individuals with mild traumatic brain injury (mTBI), particularly regarding its impact on their ability to perform daily life activities. This study aims to evaluate how CBT-I can impact sleep, mTBI symptoms, and participants' functional performance.
- Being tested
- Cognitive behavioral Therapy for insomnia (CBT-I)
- Keywords
- Sleep problems, Cognitive behavioral Therapy for insomnia, CBT-I, mild traumatic brain injury, mTBI, Functional performance
- Medical subject headings
- Brain Concussion, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral Therapy for insomnia (CBT-I)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 15 mTBI cases who have sleep problems will receive CBT-I | Experimental | We will achieve the study's aims with a single-group, pre-post design (n=15). Participants with physician-diagnosed mild traumatic brain injury who are experiencing sleep problems for more than four weeks will receive cognitive behavioral therapy for insomnia (CBT-I). Participants will engage in six one-hour, weekly CBT-I sessions delivered in a one-on-one format through the Zoom Video Conference. Participants will establish sleep-related goals. During the intervention session, the interventionist will address the cognitive and behavioral components of CBT-I, as well as relaxation techniques and sleep hygiene. Receives: Behavioral: Cognitive behavioral Therapy for insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 10 weeks.
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.
Measured: Baseline (Day 1)
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.
Measured: Baseline (Day 1)
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.
Measured: Baseline (Day 1)
Canadian Occupation Performance Measure (COPM)
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.
Measured: Baseline (day 1)
Activity Card Sort (ACS)
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.
Measured: Baseline (day 1)
Feasibility of Intervention Measure (FIM)
Feasibility of Intervention Measure (FIM) is a questionnaire that includes 12 items for evaluating acceptability, feasibility, and appropriateness of the Intervention.
Measured: Post intervention (final study visit)
Client Satisfaction Questionnaire (CSQ-8)
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.
Measured: Post intervention (final study visit)
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.
Measured: Post intervention (final study visit)
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.
Measured: Post intervention (final study visit)
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.
Measured: Post intervention (final study visit)
Canadian Occupation Performance Measure (COPM)
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.
Measured: Post intervention (final study visit)
Activity Card Sort (ACS)
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.
Measured: Post intervention (final study visit)
Secondary outcomes (12)
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.
Measured: Baseline (day 1)
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.
Measured: Baseline (day 1)
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.
Measured: Baseline (day 1)
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.
Measured: Baseline (day 1)
Depression Anxiety Stress Scale (DASS)
The Depression Anxiety Stress Scale- 21 Items (DASS-21) is a self-reported questionnaire measuring symptoms of depression, anxiety, and stress over the past week. Each subscale (Depression, Anxiety, Stress) is scored from 0 to 63, with higher scores reflecting more severe symptoms.
Measured: Baseline (day 1)
Quality of Life after Brain Injury (QOLIBRI)
The Quality of Life after Brain Injury (QOLIBRI) is a self-reported measure assessing health-related quality of life in individuals after traumatic brain injury, across physical, cognitive, emotional, and social domains. Total scores range from 0 to 100, with higher scores reflecting better quality of life.
Measured: Baseline (day 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.
Measured: Post intervention (final study visit)
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.
Measured: Post intervention (final study visit)
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.
Measured: Post intervention (final study visit)
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.
Measured: Post intervention (final study visit)
Depression Anxiety Stress Scale (DASS)
The Depression Anxiety Stress Scale- 21 Items (DASS-21) is a self-reported questionnaire measuring symptoms of depression, anxiety, and stress over the past week. Each subscale (Depression, Anxiety, Stress) is scored from 0 to 63, with higher scores reflecting more severe symptoms.
Measured: Post intervention (final study visit)
Quality of Life after Brain Injury (QOLIBRI)
The Quality of Life after Brain Injury (QOLIBRI) is a self-reported measure assessing health-related quality of life in individuals after traumatic brain injury, across physical, cognitive, emotional, and social domains. Total scores range from 0 to 100, with higher scores reflecting better quality of life.
Measured: Post intervention (final study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ArchitectureStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sepideh Zenoozi, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385105
- Sponsor's protocol ID
- 2131848
- Status last verified
- Feb 2026
- First submitted
- 11 Jan 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boone AE, Henderson WL, Zenoozi S. Surveying the Landscape of Persistent Concussive Symptoms in Adults Through an Occupational Lens. Am J Occup Ther. 2024 Mar 1;78(2):7802180190. doi: 10.5014/ajot.2024.050405.
PubMed 38373065
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)
- ClinicalTrials.gov ID
- NCT07385105
- Acronym / sponsor ID
- 2131848
- Keywords
- Sleep problems, Cognitive behavioral Therapy for insomnia, CBT-I, mild traumatic brain injury, mTBI, Functional performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does CBT-I positively impact symptoms of mTBI?
- Does CBT-I improve functional performance in individuals with mTBI?
Detailed description
Cognitive behavioral therapy for insomnia (CBT-I) is an evidence-based intervention that has demonstrated significant results in various populations. CBT-I is a structured and goal-oriented approach that addresses both unhelpful thoughts and maladaptive behaviors contributing to poor sleep. CBT-I includes several components, such as behavioral strategies that aim to change habits disrupting sleep architecture and cognitive techniques targeting maladaptive beliefs about sleep. However, limited research has examined the use of this intervention among individuals with mild traumatic brain injury (mTBI), particularly regarding its impact on their ability to perform daily life activities. This study aims to evaluate how CBT-I can impact sleep, mTBI symptoms, and participants' functional performance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| 15 mTBI cases who have sleep problems will receive CBT-I | Experimental | Behavioral: Cognitive behavioral Therapy for insomnia (CBT-I)We will achieve the study's aims with a single-group, pre-post design (n=15). Participants with physician-diagnosed mild traumatic brain injury who are experiencing sleep problems for more than four weeks will receive cognitive behavioral therapy for insomnia (CBT-I). Participants will engage in six one-hour, weekly CBT-I sessions delivered in a one-on-one format through the Zoom Video Conference. Participants will establish sleep-related goals. During the intervention session, the interventionist will address the cognitive and behavioral components of CBT-I, as well as relaxation techniques and sleep hygiene. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 15 mTBI cases who have sleep problems will receive CBT-I |
Primary outcome
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.
12 secondary outcomes
Dysexecutive Questionnaire (DEX)
Time frame: Baseline (day 1)
Neurobehavioral Symptom Inventory (NSI)
Time frame: Baseline (day 1)
Fatigue Severity Scale (FSS)
Time frame: Baseline (day 1)
Beck's Depression Inventory (BDI)
Time frame: Baseline (day 1)
Depression Anxiety Stress Scale (DASS)
Time frame: Baseline (day 1)
Quality of Life after Brain Injury (QOLIBRI)
Time frame: Baseline (day 1)
Dysexecutive Questionnaire (DEX)
Time frame: Post intervention (final study visit)
Neurobehavioral Symptom Inventory (NSI)
Time frame: Post intervention (final study visit)
Fatigue Severity Scale (FSS)
Time frame: Post intervention (final study visit)
Beck's Depression Inventory (BDI)
Time frame: Post intervention (final study visit)
Depression Anxiety Stress Scale (DASS)
Time frame: Post intervention (final study visit)
Quality of Life after Brain Injury (QOLIBRI)
Time frame: Post intervention (final study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 38373065Boone AE, Henderson WL, Zenoozi S. Surveying the Landscape of Persistent Concussive Symptoms in Adults Through an Occupational Lens. Am J Occup Ther. 2024 Mar 1;78(2):7802180190. doi: 10.5014/ajot.2024.050405.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral Therapy for insomnia (CBT-I) in people with Sleep Architecture and Mild Traumatic Brain Injury, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sepideh Zenoozi, PhD student (573-823-3082, sznmx@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expanded consensus sleep diary (CSD) (time frame: Through study completion, an average of 10 weeks.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.