N/A
N=55
Cognitive-Behavioral Therapy for Veterans With TBI
Insomnia · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02658669 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change in Insomnia Severity — 8.833; 7.810; 9.625; 8.364 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive-Behavioral Therapy for Insomnia (Behavioral); Sleep Education (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insomnia Severity |
8.833; 7.810; 9.625; 8.364 | — |
| SECONDARY Change in Depressive Symptomatology |
3.789; 1.609; 3.250; -2.250 | — |
| SECONDARY Change in PTSD Stressor Specific Checklist 5 |
8.053; 6.227; 3.125; 4.727 | — |
| SECONDARY Change in World Health Organization Disability Assessment Scale-2 |
-0.316; 1.818; 17.200; 8.273 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index |
5.412; 4.400; 5.125; 4.833 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02658669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.