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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
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• 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.

Locations
United States
Texas
Carl R. Darnall Army Medical Center
RECRUITING
Fort Cavazos
Contact Information
Primary
Ethan A Olson, B.S.
Olsone1@uthscsa.edu
5203120863
Backup
Kristi E. Pruiksma, Ph.D.
pruiksma@uthscsa.edu
210 562 6700
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 160
Treatments
Active_comparator: Cognitive Behavioral Therapy for Insomnia
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Active_comparator: Brief Behavioral Therapy for Insomnia
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Sponsors
Collaborators: Congressionally Directed Medical Research Programs, Hope Health Research Institute
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov