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

University of Missouri (MU)

Status: Begins enrollment this month

Conditions: Mild Traumatic Brain Injury; Sleep and Circadian Problems; Sleep; Sleep Architecture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07385105

2131848

Details and patient eligibility

About

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?

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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