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

Purpose

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?

Conditions

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

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
All participants will receive the intervention.
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.

Recruiting Locations

University of Missouri-Columbia
Columbia, Missouri 65211
Contact:
Sepideh Zenoozi, MSOT
573-823-3082
sznmx@missouri.edu

More Details

Status
Recruiting
Sponsor
University of Missouri-Columbia

Study Contact

Sepideh Zenoozi, PhD student
573-823-3082
sznmx@missouri.edu

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.