Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
NCT Number: NCT06551987
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Insomnia|Mild Traumatic Brain Injury
Interventions: BEHAVIORAL: Cognitive Behavioral Therapy for Insomnia|BEHAVIORAL: Brief Behavioral Therapy for Insomnia
Sponsor: The University of Texas Health Science Center at San Antonio
Collaborators: Congressionally Directed Medical Research Programs|Hope Health Research Institute
Sex: ALL
Age: ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2027-09-01

Summary:
This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).

Primary Outcome Measures: Insomnia Severity Index (ISI), The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. Each item on the ISI is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), leading to a total possible score between 0 and 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28)., Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up|Neurobehavioral Symptom Inventory (NSI), The NSI is a 22-item self-report measure that assesses postconcussive symptoms and classifies them into vestibular, somatic, cognitive, and affective factors, and indicates symptom severity. Respodents rate the severity of each sympotm on a scale from 0 (none) to 4 (very severe). Total scores range between 0-88., Baseline, 7 Week Follow-up, 12 Week Follow-up|NIH Toolbox v3, The NIH Toolbox Cognition Domain measures several aspects of cognitive functioning, including language, episodic memory, executive function, working memory and processing speed. It is a battery administered and automatically scored on the iPad, assessing cognitive function. Higher scores indicate higher levels of functioning compared nationally. A score around 130 suggest superior ability, around 115 suggest above-average fluid cognitive ability, around 100 is average compared with others nationally, around 85 suggests significantly below-average, 70 or below suggests very low functioning., Baseline, 7 Week Follow-up
Secondary Outcome Measures: Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Consisting of 18 items the DBAS evaluates the presence of and changes in sleep-related beliefs and attitudes. Sixteen items are rated from 0 "Strongly disagree" to 10 "Strongly agree.", Baseline, 7 Week Follow-up, 12 Week Follow-up|Nightmare Disorder Index (NDI), The NDI is a 5-item self-report screening measure intended to evaluate symptoms of nightmare disorder according to DSM-5 diagnostic criteria. NDI questions assess nightmare frequency, characteristics, distress, and impairment, and duration nightmares have been experienced with individual ratings ranging from 0 to 4. The index score is calculated by summing the number of nightmares per week (up to 14), number of nights with nightmares per week (0-7), and the frequency of nightmare-related awakenings (0-4), ratings of the severity of the nightmares (0-6), and the intensity of the nightmares (0-6)., Baseline, 7 Week Follow-up, 12 Week Follow-up|Epworth Sleepiness Scale (ESS), The ESS is an 8-item self-report measure that assesses the likelihood of falling asleep in various situations. The Scale scores, 0 to 5: Low daytime sleepiness (normal), 6 to 10: High daytime sleepiness (normal), 11 to 12: Mild excessive daytime sleepiness, 13 to 15: Moderate excessive daytime sleepiness, and 16 to 24: Severe excessive daytime sleepiness., Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up|Patient Health Questionnaire (PHQ-9), The PHQ-9 assesses the frequency of each of the 9 symptoms of major depressive disorder as defined by the DSM-5. Scoring measures severity of depression, as follows 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, 15-19 is moderately severe depression, 20-27 is severe depression., Baseline, 7 Week Follow-up, 12 Week Follow-up|Multidimensional Fatigue Inventory (MFI-20), The MFI-20 is a 20-item measure designed to index dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. MFI scores range from 20-100 (most severe), Baseline, 7 Week Follow-up, 12 Week Follow-up|Headache Impact Test (HIT-6), The HIT-6 is a 6-item measure of headache disability. Each item uses a 5-point Likert scale with higher scores indicating greater severity. The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78)., Baseline, 7 Week Follow-up, 12 Week Follow-up|General Anxiety Disorder (GAD-7), The GAD-7 is a 7-item measure of anxiety severity and impairment. Items use a Likert-type scale, with higher scores indicating greater severity and impairment. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety., Baseline, 7 Week Follow-up, 12 Week Follow-up|Depressive Symptoms Index-Suicidality Subscale (DSI-SS), The DSI-SS assesses current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. Scores on each item range from 0 to 3 (total score range 0-12), with higher scores reflecting greater severity of suicidal ideation., Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up