Clinical trial NCT02658669: Cognitive-Behavioral Therapy for Veterans With TBI
Official title: Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Traumatic Brain Injury
Keywords: Insomnia
Injury, Brain, Traumatic Mild
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-01-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Insomnia Severity
timeFrame: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Secondary outcomes:
measure: Change in Depressive Symptomatology
timeFrame: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
measure: Change in PTSD Stressor Specific Checklist 5
timeFrame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
measure: Change in World Health Organization Disability Assessment Scale-2
timeFrame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Other outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain
timeFrame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
measure: Change in Neuropsychological Functioning: Attention/Processing Speed
timeFrame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
measure: Change In Neuropsychological Functioning: Verbal Learning and Memory
timeFrame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
measure: Change In Neuropsychological Functioning: Executive Functioning
timeFrame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
measure: Change in Sleep Efficiency as Measured by Polysomnography
timeFrame: Pre-Treatment (0-weeks),Post-Treatment (8-weeks), Follow-Up (12-weeks)
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Henry J. Orff, PhD
role: PRINCIPAL_INVESTIGATOR
References: