RECRUITING

Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Conditions

Insomnia Mild Traumatic Brain Injury Cognitive Behavioral Therapy for Insomnia Brief Behavioral Therapy for Insomnia Active Duty Military Personnel

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-12-03

Study Completion:2027-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06551987

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.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Ethan A Olson, B.S.

CONTACT

5203120863

Olsone1@uthscsa.edu

Kristi E. Pruiksma, Ph.D.

CONTACT

210 562 6700

pruiksma@uthscsa.edu

Principal Investigator

Kristi E Pruiksma, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

Carl R. Darnall Army Medical Center

Fort Cavazos, Texas, 76544

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-03

Study Completion Date2027-09-01

Study Record Updates

Study Start Date2024-12-03

Study Completion Date2027-09-01

Terms related to this study

Keywords Provided by Researchers

Cognitive Behavioral Therapy for Insomnia
Brief Behavioral Therapy for Insomnia
Insomnia
Mild Traumatic Brain Injury
Active Duty Military Personnel

Additional Relevant MeSH Terms

Insomnia
Mild Traumatic Brain Injury