Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive behavioral Therapy for insomnia (CBT-I).
- Who it may be relevant to
- Registry conditions: Sleep Architecture, Mild Traumatic Brain Injury, Sleep, Sleep and Circadian Problems. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploring Cognitive Behavioral Therapy for Insomnia (CBT-I) in Mild Traumatic Brain Injury (mTBI)
Overview
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?
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.
Interventions
- 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 S
Primary outcome measures
- The expanded consensus sleep diary (CSD) [Time frame: Through study completion, an average of 10 weeks.]
- Insomnia Severity Index (ISI) [Time frame: Baseline (Day 1)]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline (Day 1)]
- Epworth Sleepiness Scale (ESS) [Time frame: Baseline (Day 1)]
- Canadian Occupation Performance Measure (COPM) [Time frame: Baseline (day 1)]
- Activity Card Sort (ACS) [Time frame: Baseline (day 1)]
- Feasibility of Intervention Measure (FIM) [Time frame: Post intervention (final study visit)]
- Client Satisfaction Questionnaire (CSQ-8) [Time frame: Post intervention (final study visit)]
- Insomnia Severity Index (ISI) [Time frame: Post intervention (final study visit)]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: Post intervention (final study visit)]
Secondary outcome measures (12)
- Dysexecutive Questionnaire (DEX) [Time frame: Baseline (day 1)]
- Neurobehavioral Symptom Inventory (NSI) [Time frame: Baseline (day 1)]
- Fatigue Severity Scale (FSS) [Time frame: Baseline (day 1)]
- Beck's Depression Inventory (BDI) [Time frame: Baseline (day 1)]
- Depression Anxiety Stress Scale (DASS) [Time frame: Baseline (day 1)]
- Quality of Life after Brain Injury (QOLIBRI) [Time frame: Baseline (day 1)]
- Dysexecutive Questionnaire (DEX) [Time frame: Post intervention (final study visit)]
- Neurobehavioral Symptom Inventory (NSI) [Time frame: Post intervention (final study visit)]
- Fatigue Severity Scale (FSS) [Time frame: Post intervention (final study visit)]
- Beck's Depression Inventory (BDI) [Time frame: Post intervention (final study visit)]
- Depression Anxiety Stress Scale (DASS) [Time frame: Post intervention (final study visit)]
- Quality of Life after Brain Injury (QOLIBRI) [Time frame: Post intervention (final study visit)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Missouri-Columbia — Columbia
Publications
- 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 38373065
Identifiers
NCT: NCT07385105 · 2131848