NCT07385105

Brief 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 desired daily life activities. The main questions this study aims to answer are:

  1. 1.Does CBT-I positively impact symptoms of mTBI?
  2. 2.Does CBT-I improve functional performance in individuals with mTBI?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

January 11, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 1, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

January 11, 2026

Last Update Submit

April 27, 2026

Conditions

Sleep ArchitectureMild Traumatic Brain InjurySleepSleep and Circadian Problems

Keywords

Sleep problemsCognitive behavioral Therapy for insomniaCBT-Imild traumatic brain injurymTBIFunctional performance

Outcome Measures

Primary Outcomes (13)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Post intervention (final study visit)

Secondary Outcomes (12)

  • Dysexecutive Questionnaire (DEX)

    Baseline (day 1)

  • Neurobehavioral Symptom Inventory (NSI)

    Baseline (day 1)

  • Fatigue Severity Scale (FSS)

    Baseline (day 1)

  • Beck's Depression Inventory (BDI)

    Baseline (day 1)

  • Depression Anxiety Stress Scale (DASS)

    Baseline (day 1)

  • +7 more secondary outcomes

Other Outcomes (3)

  • Montreal Cognitive Assessment (MoCA)

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

  • Patient Health Questionnaire-9 (PHQ-9)

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

  • Generalized Anxiety Disorder-7 (GAD-7)

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

Study Arms (1)

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.

Behavioral: Cognitive behavioral Therapy for insomnia (CBT-I)

Interventions

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.

15 mTBI cases who have sleep problems will receive CBT-I

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38373065BACKGROUND

MeSH Terms

Conditions

Brain ConcussionParasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Sepideh Zenoozi, PhD student

CONTACT

573-823-3082sznmx@missouri.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants will receive the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

January 11, 2026

First Posted

February 3, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)