Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Insomnia, Brief Behavioral Therapy for Insomnia.
- Who it may be relevant to
- Registry conditions: Insomnia, Mild Traumatic Brain Injury. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury
Overview
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.
Interventions
- Behavioral Cognitive Behavioral Therapy for Insomnia
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider. - Behavioral Brief Behavioral Therapy for Insomnia
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Primary outcome measures
- Insomnia Severity Index (ISI) [Time frame: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up]
- Neurobehavioral Symptom Inventory (NSI) [Time frame: Baseline, 7 Week Follow-up, 12 Week Follow-up]
- NIH Toolbox v3 [Time frame: Baseline, 7 Week Follow-up]
Secondary outcome measures (8)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Carl R. Darnall Army Medical Center — Fort Cavazos
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. PMID 32586428
- 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. PMID 32586427
- 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. PMID 32066145
Identifiers
NCT: NCT06551987 · STUDY00000222 · TP220139