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 groupsLocations
1Carl R. Darnall Army Medical Center76544, Fort CavazosTexas, United States
Sponsors 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