Clinical trial NCT06551987: Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
Official title: Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Congressionally Directed Medical Research Programs
name: Hope Health Research Institute
First posted: 2024-08-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Baseline, 7 Week Follow-up, 12 Week Follow-up
measure: NIH Toolbox v3
timeFrame: Baseline, 7 Week Follow-up
Secondary outcomes:
measure: Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
timeFrame: Baseline, 7 Week Follow-up, 12 Week Follow-up
measure: Nightmare Disorder Index (NDI)
timeFrame: Baseline, 7 Week Follow-up, 12 Week Follow-up
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 7 Week Follow-up, 12 Week Follow-up
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: Baseline, 7 Week Follow-up, 12 Week Follow-up
measure: Headache Impact Test (HIT-6)
timeFrame: Baseline, 7 Week Follow-up, 12 Week Follow-up
measure: General Anxiety Disorder (GAD-7)
timeFrame: Baseline, 7 Week Follow-up, 12 Week Follow-up
measure: Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
timeFrame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up
Other outcomes:
Locations:
city: Fort Cavazos
country: United States
facility: Carl R. Darnall Army Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Kristi E Pruiksma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.