Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Description

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).

Conditions

Insomnia, Mild Traumatic Brain Injury

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Fort Cavazos

Carl R. Darnall Army Medical Center, Fort Cavazos, Texas, United States, 76544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Kristi E Pruiksma, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

2027-09-01