Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Last updated: December 16, 2024
Sponsor: The University of Texas Health Science Center at San Antonio
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Brain Injury

Neurologic Disorders

Treatment

Brief Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia

Clinical Study ID

NCT06551987
STUDY00000222
TP220139
  • Ages 18-45
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 toenrollment based on self-report.

  • At least 2 postconcussive symptoms scored > 2 (moderate) on the NeurobehavioralSymptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domainin addition to the sleep disturbances item.

  • Clinically significant chronic insomnia disorder assessed by an independentevaluator 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 apneafor at least 1 month.

Exclusion

Exclusion Criteria:

  • Moderate TBI (e.g., skull fracture, brain hemorrhage, hematoma) indicated byself-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 riskprofessions; very short sleep duration of less than 4 hours on average; bipolardisorder or psychosis) or that otherwise interferes with the completion of thebaseline assessment.

  • Working night shifts (i.e., duty later than 9:00 pm or before 5:30 am) more than 3times per month.

  • Planned major surgery.

  • Pregnancy, assessed by self-report and review of medical record.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Brief Behavioral Therapy for Insomnia
Phase:
Study Start date:
December 03, 2024
Estimated Completion Date:
September 01, 2027

Study 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.

Connect with a study center

  • Carl R. Darnall Army Medical Center

    Fort Cavazos, Texas 76544
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.