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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE April 1, 2016
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02658669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 22, 2016)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: January 14, 2016)
  • 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.
  • Change in sleep efficiency as measured by polysomnography [ Time Frame: 6-weeks ]
    Change in sleep efficiency will be assessed through overnight polysomnographic sleep studies.
 
Descriptive Information
Brief Title  ICMJE CBT-I for Veterans With TBI
Official Title  ICMJE Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Traumatic Brain Injury
Intervention  ICMJE
  • 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
  • Behavioral: Sleep Education
    Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.
Study Arms  ICMJE
  • Experimental: Cognitive-Behavioral Therapy for Insomnia
    6-week manualized treatment designed to improve symptoms of chronic insomnia.
    Intervention: Behavioral: Cognitive-Behavioral Therapy for Insomnia
  • 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.
    Intervention: Behavioral: Sleep Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Henry J Orff, PhD (858) 642-6492 Henry.Orff@va.gov
Contact: Jennifer S Salamat, BS (858) 552-8585 ext 5596 jennifer.salamat@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02658669
Other Study ID Numbers  ICMJE D1512-W
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henry J. Orff, PhD VA San Diego Healthcare System, San Diego, CA
PRS Account VA Office of Research and Development
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP