CBT-I for Veterans With TBI

Not Applicable

Completed

• Conditions: Insomnia; Traumatic Brain Injury
• Interventions: Behavioral: Cognitive-Behavioral Therapy for Insomnia; Behavioral: Sleep Education

• Registration Number: NCT02658669
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-20
• Study Start: 2016-04-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy for Insomnia	Cognitive-Behavioral Therapy for Insomnia	6-week manualized treatment designed to improve symptoms of chronic insomnia.
Sleep Education	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.

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity	Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Depressive Symptomatology	Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) a self-report measure of depression. Minimum value = 0; maximum value = 27. Lower scores indicate fewer depressive symptoms.
Change in PTSD Stressor Specific Checklist 5	Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in PTSD symptoms assessed using the PTSD Stressor Specific Checklist 5 (PCL-5) a self-report measure of PTSD. Minimum score = 0, maximum score = 80. Lower scores indicate less PTSD symptomatology.
Change in World Health Organization Disability Assessment Scale-2	Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in global functioning and disability will be assessed using the World Health Organization Disability Assessment Scale-2, a self-report measure. Minimum value = 0; maximum value = 100. Lower scores indicates less disability.
Change in Pittsburgh Sleep Quality Index	Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). Minimum value = 0; maximum value= 21. Lower score indicates less general sleep disturbance.

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States