Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
NCT ID: NCT06551987
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2024-12-03
2027-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive Behavioral Therapy for Insomnia
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Cognitive Behavioral Therapy for Insomnia
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Brief Behavioral Therapy for Insomnia
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Brief Behavioral Therapy for Insomnia
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Interventions
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Cognitive Behavioral Therapy for Insomnia
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Brief Behavioral Therapy for Insomnia
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
No
Sponsors
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Congressionally Directed Medical Research Programs
FED
Hope Health Research Institute
UNKNOWN
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Kristi Pruiksma
Associate Professor
Principal Investigators
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Kristi E Pruiksma, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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Carl R. Darnall Army Medical Center
Fort Cavazos, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Scot D Engel, PsyD
Role: primary
Kristi E Pruiksma, PhD
Role: backup
References
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Bramoweth AD, Lederer LG, Youk AO, Germain A, Chinman MJ. Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. Behav Ther. 2020 Jul;51(4):535-547. doi: 10.1016/j.beth.2020.02.002. Epub 2020 Feb 20.
Pruiksma KE, Hale WJ, Mintz J, Peterson AL, Young-McCaughan S, Wilkerson A, Nicholson K, Dondanville KA, Fina BA, Borah EV, Roache JD, Litz BT, Bryan CJ, Taylor DJ; STRONG STAR Consortium. Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel. Behav Ther. 2020 Jul;51(4):522-534. doi: 10.1016/j.beth.2020.02.001. Epub 2020 Feb 14.
Mysliwiec V, Martin JL, Ulmer CS, Chowdhuri S, Brock MS, Spevak C, Sall J. The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines. Ann Intern Med. 2020 Mar 3;172(5):325-336. doi: 10.7326/M19-3575. Epub 2020 Feb 18.
Other Identifiers
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TP220139
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00000222
Identifier Type: -
Identifier Source: org_study_id