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
Qualifiers
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
Treatments tested in this trial
- Cognitive Behavioral Therapy for Insomnia
- Brief Behavioral Therapy for Insomnia
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
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