Surveying the Landscape of Persistent Concussive Symptoms in Adults Through an Occupational Lens.
Anna E Boone, Whitney L Henderson, Sepideh Zenoozi
https://pubmed.ncbi.nlm.nih.gov/38373065/Actively Recruiting
Led by University of Missouri-Columbia · Updated on 2026-05-01
15
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are evaluating cognitive behavioral therapy for insomnia CBT-I among individuals with mild traumatic brain injury mTBI who experience sleep disturbances. The study aims to assess how CBT-I affects sleep quality, mTBI symptoms, and participants ability to perform their desired daily activities. The main questions include whether CBT-I improves mTBI symptoms and functional performance in those affected. Participants diagnosed with mTBI and experiencing sleep problems for more than four weeks will receive six weekly one-hour CBT-I sessions delivered one-on-one via Zoom. The therapy includes behavioral and cognitive strategies, relaxation techniques, and sleep hygiene education. Participants will set sleep-related goals and engage actively in structured sessions to address thoughts and behaviors that disrupt sleep. Throughout the study, participants will complete various assessments including sleep diaries, insomnia severity indexes, sleep quality questionnaires, and measures of daily function and symptom severity. These evaluations will occur at baseline and after the intervention to monitor changes. Researchers will also assess therapy feasibility and participant satisfaction. The total study duration spans approximately 10 weeks, including the intervention and follow-up assessments.
CONDITIONS
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
S
Sepideh Zenoozi, PhD student
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University of Missouri-Columbia
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CBT‑I (trial intervention) | Usual non‑structured insomnia care |
|---|---|---|
| What it is | A structured behavioral‑cognitive psychotherapy for insomnia adapted for adults with mild traumatic brain injury, delivered one‑on‑one via Zoom weekly for six weeks | Non‑structured or general insomnia care (e.g., informal advice or sleep hygiene education without a structured CBT‑I programme) |
| Role in trial | Investigational therapy administered to all participants | Represents typical clinical approaches outside structured programmes |
| Primary use | To reduce insomnia symptoms and improve sleep quality and daily functioning following mTBI | Address insomnia via general advice and sleep hygiene strategies |
| How it is given or performed | Delivered weekly via one‑on‑one Zoom sessions, lasting one hour each, over six weeks | Typically informal advice or printed guidance without scheduled sessions |
| Evidence status | Effectiveness for insomnia in mTBI is being evaluated in this trial; prior evidence in brain‑injury populations remains limited | Informal sleep hygiene strategies are commonly used but not as effective as structured CBT‑I |
| Important risks | None reported; behavioural intervention is low‑risk | Minimal risks associated with general advice |
| Important limitations | Single‑group design without control arm limits causal inference | Contextual comparator is inferred and not tested in this trial |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) for eligibility assessment
Duration - 6 weeks
Participants receive cognitive behavioral therapy for insomnia (CBT-I) in a one-on-one format via Zoom. This structured therapy includes behavioral and cognitive techniques to improve sleep and related symptoms.
Weekly 1-hour sessions via Zoom
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Anna E Boone, Whitney L Henderson, Sepideh Zenoozi
https://pubmed.ncbi.nlm.nih.gov/38373065/University of Missouri-Columbia
Lead Sponsor