NCT06551987NARecruiting

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

The University of Texas Health Science Center at San Antonio

Start Date

12/3/2024

Completion Date

9/1/2027

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).

Detailed Description

The purpose of this study is to identify the optimal behavioral treatment for insomnia in service members with comorbid insomnia and prolonged postconcussive symptoms following Mild Traumatic Brain Injury (mTBI). The study will compare Cognitive Behavioral Therapy for Insomnia (CBT-I) and Brief Behavioral Therapy for Insomnia (BBT-I) and determine the impact of behavioral insomnia treatment on insomnia symptom severity. This study will explore the impact of insomnia treatment on prolonged postconcussive symptoms and blood-based biomarkers. The overall objective is to determine if behavioral insomnia therapy can improve outcomes in service members with prolonged postconcussive symptoms following mTBI. Both in-person and telehealth treatment formats will be offered to adapt to the service members schedule. The minimum acceptable number of sessions to the interventions in order to have evaluable data will be 4 sessions for CBT-I and 3 sessions for BBT-I. A participant is considered to have completed the study if he or she has completed the baseline assessment, at least 4 sessions for CBT-I and 3 sessions for BBT-I, and the 7-week and 12-week follow-up assessments. Participants will be seen and treated at the Intrepid Spirit Center and/or the STRONG STAR offices both part of the Carl R. Darnall Army Medical Center (CRDAMC) located on the Fort Cavazos. Active duty service members at least 18 years of age who are seeking clinical care for persisting mTBI symptoms at the Intrepid Spirit Center located on Fort Cavazos. Women will be actively recruited into the study.

Eligibility Criteria

Age Range: 18 years to 45 years

Inclusion Criteria: * 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. * At least 2 postconcussive symptoms scored \> 2 (moderate) on the Neurobehavioral Symptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domain in addition to the sleep disturbances item. * Clinically significant chronic insomnia disorder assessed by an independent evaluator using the Structured Clinical Interview for Sleep Disorders-Revised (SCISD-R)\_No Split Week Self-Assessment of Sleep Survey (SASS-Y). * Minimum score of 15 on the Insomnia Severity Index (ISI). * Plans to be in the area for the next 3 months. * Stable on psychotropic and hypnotic medications for at least 1 month. * Stable on continuous positive airway pressure therapy if diagnosed with sleep apnea for at least 1 month. Exclusion Criteria: * 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. * Pregnancy, assessed by self-report and review of medical record.

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

BEHAVIORAL

Brief Behavioral Therapy for Insomnia

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Conditions

InsomniaMild Traumatic Brain Injury

Locations

Carl R. Darnall Army Medical Center

Fort Cavazos, Texas 76544

United States