InsomniaNCT06551987
Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
A study testing Cognitive Behavioral Therapy for Insomnia and Brief Behavioral Therapy for Insomnia in people with Insomnia and Mild Traumatic Brain Injury, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Insomnia, Mild Traumatic Brain Injury
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia and Brief Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carl R. Darnall Army Medical Center
Fort Cavazos, Texas, 76544
Scot D Engel, PsyD, (254) 287-7281
Kristi E Pruiksma, PhD, (210) 562-6700, pruiksma@uthscsa.edu
About this study
Official title: Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury
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).
Read the detailed 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.
- Conditions
- Insomnia, Mild Traumatic Brain Injury
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Brief Behavioral Therapy for Insomnia
- Keywords
- Cognitive Behavioral Therapy for Insomnia, Brief Behavioral Therapy for Insomnia, Insomnia, Mild Traumatic Brain Injury, Active Duty Military Personnel
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Brief Behavioral Therapy for InsomniaBehavioural
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Active comparator | 6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Brief Behavioral Therapy for Insomnia | Active comparator | 4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider. Receives: Behavioral: Brief Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. Each item on the ISI is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), leading to a total possible score between 0 and 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
Neurobehavioral Symptom Inventory (NSI)
The NSI is a 22-item self-report measure that assesses postconcussive symptoms and classifies them into vestibular, somatic, cognitive, and affective factors, and indicates symptom severity. Respondents rate the severity of each symptom on a scale from 0 (none) to 4 (very severe). Total scores range between 0-88.
Measured: Baseline, 7 Week Follow-up, 12 Week Follow-up
NIH Toolbox v3
The NIH Toolbox Cognition Domain measures several aspects of cognitive functioning, including language, episodic memory, executive function, working memory and processing speed. It is a battery administered and automatically scored on the iPad, assessing cognitive function. Higher scores indicate higher levels of functioning compared nationally. A score around 130 suggest superior ability, around 115 suggest above-average fluid cognitive ability, around 100 is average compared with others nationally, around 85 suggests significantly below-average, 70 or below suggests very low functioning.
Measured: Baseline, 7 Week Follow-up
Secondary outcomes (8)
Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Consisting of 18 items the DBAS evaluates the presence of and changes in sleep-related beliefs and attitudes. Sixteen items are rated from 0 "Strongly disagree" to 10 "Strongly agree."
Measured: Baseline, 7 Week Follow-up, 12 Week Follow-up
Nightmare Disorder Index (NDI)
The NDI is a 5-item self-report screening measure intended to evaluate symptoms of nightmare disorder according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) diagnostic criteria. NDI questions assess nightmare frequency, characteristics, distress, and impairment, and duration nightmares have been experienced with individual ratings ranging from 0 to 4. The index score is calculated by summing the number of nightmares per week (up to 14), number of nights with nightmares per week (0-7), and the frequency of nightmare-related awakenings (0-4), ratings of the severity of the nightmares (0-6), and the intensity of the nightmares (0-6).
Measured: Baseline, 7 Week Follow-up, 12 Week Follow-up
Epworth Sleepiness Scale (ESS)
The ESS is an 8-item self-report measure that assesses the likelihood of falling asleep in various situations. The Scale scores, 0 to 5: Low daytime sleepiness (normal), 6 to 10: High daytime sleepiness (normal), 11 to 12: Mild excessive daytime sleepiness, 13 to 15: Moderate excessive daytime sleepiness, and 16 to 24: Severe excessive daytime sleepiness.
Measured: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
Patient Health Questionnaire (PHQ-9)
The PHQ-9 assesses the frequency of each of the 9 symptoms of major depressive disorder as defined by the DSM-5. Scoring measures severity of depression, as follows 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, 15-19 is moderately severe depression, 20-27 is severe depression.
Measured: Baseline, 7 Week Follow-up, 12 Week Follow-up
Multidimensional Fatigue Inventory (MFI-20)
The MFI-20 is a 20-item measure designed to index dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. MFI scores range from 20-100 (most severe)
Measured: Baseline, 7 Week Follow-up, 12 Week Follow-up
Headache Impact Test (HIT-6)
The HIT-6 is a 6-item measure of headache disability. Each item uses a 5-point Likert scale with higher scores indicating greater severity. The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).
Measured: Baseline, 7 Week Follow-up, 12 Week Follow-up
General Anxiety Disorder (GAD-7)
The GAD-7 is a 7-item measure of anxiety severity and impairment. Items use a Likert-type scale, with higher scores indicating greater severity and impairment. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.
Measured: Baseline, 7 Week Follow-up, 12 Week Follow-up
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
The DSI-SS assesses current suicidal ideation. The DSI-SS is a 4-item self-report measure of suicidal ideation that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. Scores on each item range from 0 to 3 (total score range 0-12), with higher scores reflecting greater severity of suicidal ideation.
Measured: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start3 Dec 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, Hope Health Research Institute
- Responsible party
- Principal investigator, Kristi Pruiksma, The University of Texas Health Science Center at San Antonio
- Investigators
- Kristi E Pruiksma, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551987
- Sponsor's protocol ID
- STUDY00000222
- Other IDs
- TP220139
- Status last verified
- Dec 2025
- First submitted
- 9 Aug 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32586428Pruiksma 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.
PubMed 32586427Mysliwiec 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.
PubMed 32066145
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06551987
- Acronym / sponsor ID
- STUDY00000222
- Conditions
- Insomnia, Mild Traumatic Brain Injury
- Keywords
- Cognitive Behavioral Therapy for Insomnia, Brief Behavioral Therapy for Insomnia, Insomnia, Mild Traumatic Brain Injury, Active Duty Military Personnel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, Hope Health Research Institute
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Active comparator | Behavioral: Cognitive Behavioral Therapy for Insomnia6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider. |
| Brief Behavioral Therapy for Insomnia | Active comparator | Behavioral: Brief Behavioral Therapy for Insomnia4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider. | Behavioural | Cognitive Behavioral Therapy for Insomnia |
| Brief Behavioral Therapy for Insomnia4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider. | Behavioural | Brief Behavioral Therapy for Insomnia |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. Each item on the ISI is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), leading to a total possible score between 0 and 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Neurobehavioral Symptom Inventory (NSI)
Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up
The NSI is a 22-item self-report measure that assesses postconcussive symptoms and classifies them into vestibular, somatic, cognitive, and affective factors, and indicates symptom severity. Respondents rate the severity of each symptom on a scale from 0 (none) to 4 (very severe). Total scores range between 0-88.
NIH Toolbox v3
Time frame: Baseline, 7 Week Follow-up
The NIH Toolbox Cognition Domain measures several aspects of cognitive functioning, including language, episodic memory, executive function, working memory and processing speed. It is a battery administered and automatically scored on the iPad, assessing cognitive function. Higher scores indicate higher levels of functioning compared nationally. A score around 130 suggest superior ability, around 115 suggest above-average fluid cognitive ability, around 100 is average compared with others nationally, around 85 suggests significantly below-average, 70 or below suggests very low functioning.
8 secondary outcomes
Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up
Nightmare Disorder Index (NDI)
Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up
Multidimensional Fatigue Inventory (MFI-20)
Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up
Headache Impact Test (HIT-6)
Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up
General Anxiety Disorder (GAD-7)
Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
Time frame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 32586428Bramoweth 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.
- Background: PubMed 32586427Pruiksma 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.
- Background: PubMed 32066145Mysliwiec 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristi E Pruiksma, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia and Brief Behavioral Therapy for Insomnia in people with Insomnia and Mild Traumatic Brain Injury, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella McElwain, B.S. (254-226-6987, Isabella.l.mcelwain.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06551987, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.