Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Active duty U.S. military service members.
At least 18 years of age.
Ability to provide informed consent and follow study-related instructions.
Self-report of a Mild Traumatic Brain Injury (mTBI) at least 3 months prior to enrollment based on self-report.
Disqualifiers
Moderate TBI (e.g., skull fracture, brain hemorrhage, hematoma) indicated by self-report or medical record.
Any sleep, medical, or psychiatric disorder requiring urgent treatment (e.g., suicide risk, substance use, insomnia with occupational impairment in high risk professions; very short sleep duration of less than 4 hours on average; bipolar disorder or psychosis) or that otherwise interferes with the completion of the baseline assessment.
Working night shifts (i.e., duty later than 9:00 pm or before 5:30 am) more than 3 times per month.
Planned major surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Insomnia
Behavioral6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Brief Behavioral Therapy for Insomnia
Behavioral4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioral Therapy for InsomniaActive comparator 1 intervention
Group B: Brief Behavioral Therapy for InsomniaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up2
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. Respondents rate the severity of each symptom on a scale from 0 (none) to 4 (very severe). Total scores range between 0-88.
Time frame
Baseline, 7 Week Follow-up, 12 Week Follow-up3
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.
Time frame
Baseline, 7 Week Follow-upSecondary outcomes
1
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."
Time frame
Baseline, 7 Week Follow-up, 12 Week Follow-up2
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 and Statistical Manual of Mental Disorders-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).
Time frame
Baseline, 7 Week Follow-up, 12 Week Follow-up3
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.
Time frame
Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up4
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.
Time frame
Baseline, 7 Week Follow-up, 12 Week Follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Hope Health Research Institute
Collaborator
Source ClinicalTrials.gov