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

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT07385105
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury
  • Sleep
  • Sleep Architecture
  • Sleep and Circadian Problems

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

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.

Study Details

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?

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: 15 mTBI cases who have sleep problems will receive 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.

Primary Outcome Measure

The expanded consensus sleep diary (CSD) [ Time Frame: Through study completion, an average of 10 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Missouri-ColumbiaColumbiaMissouri65211
Sepideh Zenoozi, MSOT
[email protected]
573-823-3082

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By research site
University of Missouri-Columbia· Columbia, MO

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