CBT-I for Veterans With TBI
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|ClinicalTrials.gov Identifier: NCT02658669|
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Traumatic Brain Injury||Behavioral: Cognitive-Behavioral Therapy for Insomnia Behavioral: Sleep Education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI|
|Actual Study Start Date :||April 1, 2016|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Cognitive-Behavioral Therapy for Insomnia
6-week manualized treatment designed to improve symptoms of chronic insomnia.
Behavioral: Cognitive-Behavioral Therapy for Insomnia
Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training.
Other Name: CBT-I
Active Comparator: Sleep Education
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
Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.
- Change in Sleep Efficiency [ Time Frame: 3-weeks, 6-weeks, 10-weeks ]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.
- Change in depressive symptomatology [ Time Frame: 3-weeks, 6-weeks, 10-weeks ]Change in depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9) a self-report measure of depression
- Change in PTSD Stressor Specific Checklist 5 [ Time Frame: 3-weeks, 6-weeks, 10-weeks ]Change in PTSD symptoms will be assessed using the PTSD Stressor Specific Checklist 5 a self-report measure of PTSD.
- Change in World Health Organization Disability Assessment Scale-2 [ Time Frame: 3-weeks, 6-weeks, 10-weeks ]Change in global functioning and disability will be assessed using the World Health Organization Disability Assessment Scale-2, a self-report measure.
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) pain [ Time Frame: 6-weeks, 10-weeks ]Change in pain will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) pain assessment, as self-report measure of pain
- Change in global deficit score (composite score) of neuropsychological functioning [ Time Frame: 6-weeks, 10-weeks ]Change in cognitive functioning will be evaluated through use of a global deficit score (composite score) comprised of standardized assessments of attention, memory, and executive functioning. The tasks that will be administered include: the Wide Range Achievement Test-4 Reading to obtain a premorbid IQ estimate, Word memory Test (WMT) to measure effort testing, Psychomotor Vigilance Task (PVT) to measure attention, Paced Auditory Serial Addition Test (PASAT) to measure working memory, WAIS-IV Digit Symbol and Symbol Search to measure processing speed, Hopkins Verbal Learning Test-Revised (HVLT-R) to measure learning and memory, and the Delis-Kaplan Executive Function Scale (D-KEFS) Trials and Color-Word Tasks to measure executive functioning.
- Change in sleep efficiency as measured by polysomnography [ Time Frame: 6-weeks ]Change in sleep efficiency will be assessed through overnight polysomnographic sleep studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658669
|Contact: Henry J Orff, PhD||(858) 642-6492||Henry.Orff@va.gov|
|Contact: Jennifer S Salamat, BS||(858) 552-8585 ext email@example.com|
|United States, California|
|VA San Diego Healthcare System, San Diego, CA||Recruiting|
|San Diego, California, United States, 92161|
|Contact: Gerhard H Schulteis, PhD 858-642-3657 firstname.lastname@example.org|
|Principal Investigator: Henry J. Orff, PhD|
|Principal Investigator:||Henry J. Orff, PhD||VA San Diego Healthcare System, San Diego, CA|