CBT-I for Veterans With TBI

Study Overview
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Brief Summary
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Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI patients has the potential to exacerbate other symptoms, delay recovery, and negatively affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has been shown to be an effective evidence-based treatment for insomnia, there are no published randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who have suffered mTBI.

Detailed Description
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This VA Rehabilitation Research and Development Career Development Award (CDA-2) proposal is designed to significantly advance the application of Behavioral Sleep Medicine practices in the treatment of Veterans seen in the VA Healthcare System, especially those recovering from traumatic brain injury (TBI). TBI has been deemed the signature wound of the Iraq and Afghanistan Wars, occurring in about 19.5% of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) service members. For many Veterans, mild traumatic brain injury (mTBI) can be associated with persistent post-concussive symptoms, especially sleep disturbances. Sleep disturbances are among the most frequent complaints following mTBI, with studies suggesting that over 93% of Veterans who experienced brain injuries develop chronic sleep problems. Of the sleep disturbances diagnosed in this patient population the most common is insomnia, observed in over 50% of patients. Chronic and untreated insomnia is known to be associated with and/or increase risk for psychiatric problems, suicidal ideation, and unhealthy lifestyles (e.g., alcohol/drug abuse), lead to poorer physical health, disruption in major social and occupational responsibilities, and decreased quality of life, and may generally contribute to the persistence of post-concussive symptoms beyond the expected period of recovery. As such, treatment of sleep disturbance represents an essential component of Veteran care, one which may be particularly beneficial for Veterans with history of mTBI who commonly present to the clinic with complex multi-symptom concerns. To address this important clinical issue, the proposed randomized clinical trial (RCT) will attempt to assess the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBT-I) versus a Sleep Education control in Veterans with insomnia and a history of mTBI. CBT-I is recommended by the American Academy of Sleep Medicine for treatment of chronic insomnia and has also been adopted by the VA within an Evidence Based Practice roll-out program. Despite the acceptance of CBT-I as a first line treatment for sleep disturbance, there are no published RCTs evaluating CBT-I in mTBI patient populations. Therefore, this proposed investigation will address this gap in the literature by assessing the efficacy of CBT-I in Veterans with history of head injury.

Official Title
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Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI

Conditions
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Insomnia, Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy for Insomnia
* Behavioral: Sleep Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OEF/OIF/OND Veteran ages 18-55. Documented history of mild TBI (documented in the medical record and where possible from the VA TBI second-level evaluation) Loss of consciousness 30 minutes Post-traumatic amnesia 1 day At least 3 months post-TBI. A diagnosis of insomnia classified as: Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria that include: trouble falling asleep, staying asleep, waking too early, and/or non-restorative sleep with accompanied daytime impairment in functioning for > 3 months, occurring at least 3 nights per week. Subjective sleep disturbance defined by a Pittsburgh Sleep Quality Index score >5 and Insomnia Severity Index score >7 at intake. No prior exposure to and/or treatment with CBT-I within the past 2 years. Must be stable on medication regimen for at least 1 month prior to enrollment in study. Exclusion Criteria: History of a neurological disorder (besides TBI), dementia, or premorbid IQ <70. Schizophrenia, psychotic disorder, and/or bipolar disorder. Evidence of suicidality more than low risk as determined by the VA Comprehensive Suicide Risk Assessment (CSRA). Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea and/or periodic limb movements) Alcohol and/or substance abuse within the past 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Behavioral Therapy for Insomnia<br>6-week manualized treatment designed to improve symptoms of chronic insomnia. | Behavioral: Cognitive-Behavioral Therapy for Insomnia<br>* Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training.<br>* Other names: CBT-I;|
| Active Comparator: Sleep Education<br>6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning. | Behavioral: Sleep Education<br>* Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from daily sleep logs filled out by patient. | 3-weeks, 6-weeks, 10-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptomatology | Change in depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9) a self-report measure of depression | 3-weeks, 6-weeks, 10-weeks | 
| Change in PTSD Stressor Specific Checklist 5 | Change in PTSD symptoms will be assessed using the PTSD Stressor Specific Checklist 5 a self-report measure of PTSD. | 3-weeks, 6-weeks, 10-weeks | 
| Change in World Health Organization Disability Assessment Scale-2 | Change in global functioning and disability will be assessed using the World Health Organization Disability Assessment Scale-2, a self-report measure. | 3-weeks, 6-weeks, 10-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Injury, Brain, Traumatic Mild