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CBT-I for Veterans With TBI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02658669
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : March 2, 2021
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Traumatic Brain Injury Behavioral: Cognitive-Behavioral Therapy for Insomnia Behavioral: Sleep Education Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

Other Outcome Measures:
  1. 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

  2. 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.

  3. Change in sleep efficiency as measured by polysomnography [ Time Frame: 6-weeks ]
    Change in sleep efficiency will be assessed through overnight polysomnographic sleep studies.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. OEF/OIF/OND Veteran ages 18-55.
  2. Documented history of mild TBI (documented in the medical record and where possible from the VA TBI second-level evaluation)

    1. Loss of consciousness 30 minutes
    2. Post-traumatic amnesia 1 day
  3. At least 3 months post-TBI.
  4. A diagnosis of insomnia classified as:

    1. 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.
    2. Subjective sleep disturbance defined by a Pittsburgh Sleep Quality Index score >5 and Insomnia Severity Index score >7 at intake.
  5. No prior exposure to and/or treatment with CBT-I within the past 2 years.
  6. Must be stable on medication regimen for at least 1 month prior to enrollment in study.

Exclusion Criteria:

  1. History of a neurological disorder (besides TBI), dementia, or premorbid IQ <70.
  2. Schizophrenia, psychotic disorder, and/or bipolar disorder.
  3. Evidence of suicidality more than "low risk" as determined by the VA Comprehensive Suicide Risk Assessment (CSRA).
  4. Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea and/or periodic limb movements)
  5. Alcohol and/or substance abuse within the past 30 days.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02658669

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Contact: Henry J Orff, PhD (858) 642-6492
Contact: Jennifer S Salamat, BS (858) 552-8585 ext 5596

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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   
Principal Investigator: Henry J. Orff, PhD         
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Henry J. Orff, PhD VA San Diego Healthcare System, San Diego, CA
Additional Information:
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Responsible Party: VA Office of Research and Development Identifier: NCT02658669    
Other Study ID Numbers: D1512-W
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Injury, Brain, Traumatic Mild
Additional relevant MeSH terms:
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Brain Injuries
Sleep Initiation and Maintenance Disorders
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders