Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans.
Adam D Bramoweth, Lisa G Lederer, Ada O Youk...
https://pubmed.ncbi.nlm.nih.gov/32586428Actively Recruiting
Phase Not Applicable
Age: 18Years - 45Years
All Genders
ID06551987
Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-01-07
160
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the best behavioral treatment for insomnia in active duty service members who have both insomnia and prolonged postconcussive symptoms lasting at least three months after a mild traumatic brain injury (mTBI). This study compares Cognitive Behavioral Therapy for Insomnia (CBT-I) with Brief Behavioral Therapy for Insomnia (BBT-I) to see how each affects insomnia severity and related postconcussive symptoms. The research also investigates the impact on blood-based biomarkers to better understand treatment effects. Participants will receive either six weekly 50-minute sessions of CBT-I or four weekly 30-minute sessions of BBT-I, both delivered individually by trained behavioral health providers. Treatments can be given in person or through telehealth to fit participants' schedules. Completion requires attending at least four CBT-I sessions or three BBT-I sessions, along with baseline, 7-week, and 12-week follow-up assessments. During the study, participants will undergo evaluations that include the Insomnia Severity Index, Neurobehavioral Symptom Inventory, and NIH Toolbox assessments at baseline and follow-ups. Additional questionnaires will assess sleep beliefs, nightmares, sleepiness, mood, fatigue, headache impact, anxiety, and suicidality. The study lasts about 12 weeks, with monitoring to track changes in symptoms and treatment effects.
CONDITIONS
Brief Title
Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
Who Can Participate
Age: 18Years - 45Years
All Genders
Eligibility Criteria
You may qualify if you...
- Active duty U.S. military service members
- At least 18 years of age and no older than 45 years
- Ability to provide informed consent and follow study-related instructions
- Self-report of mild traumatic brain injury at least 3 months prior to enrollment
- At least 2 postconcussive symptoms scored greater than 2 on the Neurobehavioral Symptom Inventory, including at least 1 cognitive symptom and sleep disturbances
- Clinically significant chronic insomnia disorder confirmed by independent evaluator
- Minimum score of 15 on the Insomnia Severity Index
- Plans to remain 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 for sleep apnea for at least 1 month
You will not qualify if you...
- Moderate traumatic brain injury such as skull fracture or brain hemorrhage
- Any urgent sleep, medical, or psychiatric disorder interfering with baseline assessment or requiring urgent treatment
- Working night shifts more than 3 times per month
- Planned major surgery during the study period
- Pregnancy confirmed by self-report and medical records
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or telehealth)
Outpatient Treatment
Duration - 4 to 6 weeks depending on therapy assigned
Participants receive behavioral therapy sessions for insomnia either through Cognitive Behavioral Therapy for Insomnia (6 weekly sessions) or Brief Behavioral Therapy for Insomnia (4 weekly sessions), delivered individually by a trained provider in-person or via telehealth.
Weekly visits for 4 to 6 weeks
Follow-up
Duration - Up to 12 weeks after baseline assessment
Participants complete follow-up assessments to evaluate insomnia symptom severity and postconcussive symptoms at 7 weeks and 12 weeks after baseline.
2 follow-up visits (in-person or telehealth)
Trial Site Locations
Total: 1 location
1
Carl R. Darnall Army Medical Center
Fort Cavazos, Texas, United States, 76544
Actively Recruiting
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Research Team
I
Isabella McElwain, B.S.
K
Kristi E. Pruiksma, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel.
Kristi E Pruiksma, Willie J Hale, Jim Mintz...
https://pubmed.ncbi.nlm.nih.gov/32586427The 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.
Vincent Mysliwiec, Jennifer L Martin, Christi S Ulmer...
https://pubmed.ncbi.nlm.nih.gov/32066145