Cognitive-Behavioral Therapy for Veterans With TBI

Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02658669

Enrollment

Registered

2016-01-20

Start date

2016-04-01

Completion date

2022-09-30

Last updated

2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Traumatic Brain Injury

Keywords

Insomnia, Injury, Brain, Traumatic Mild

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.

Interventions

BEHAVIORALCognitive-Behavioral Therapy for Insomnia

Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training.

BEHAVIORALSleep Education

Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain	Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in pain will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) pain assessment, as self-report measure of pain. Measures are scored on a T-score (mean=50, SD=10) Minimum score = \<20 ; maximum score = \>80. Lower scores indicate less pain interference in daily life.
Change in Neuropsychological Functioning: Attention/Processing Speed	Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in cognitive functioning will be evaluated through standardized assessments of attention and processing speed. The tasks that will be administered include: the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Digit Symbol and Symbol Search to measure attention and processing speed. WAIS-IV raw minimum value score=45; maximum score=155. Scaled score used: minimum score = 1; maximum score = 19. Higher score equals a better outcome.
Change In Neuropsychological Functioning: Verbal Learning and Memory	Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in cognitive functioning will be evaluated through standardized assessments of verbal learning and memory. The Hopkins Verbal Learning Test-Revised (HVLT-R) was used to measure learning and memory, and was measured by Total Recall score and Delayed Recall score. HVLT Total Recall raw scores minimum value=0; maximum value=36. Measures scored on a T-Score; minimum t-score score:0, maximum t-score \>80. Higher t-scores indicate better outcome. HVLT delayed recall minimum raw score value=0; maximum value=12. Measures scored on a T-Score; maximum t-score value: 60, minimum =0. Higher t-scores indicate better outcome. Population mean and standard deviation calculated based on age. Mean age of the population was 36 years = total recall population t score mean: 28.04, SD: 4.43. Delayed recall population t score mean: 9.92, SD: 2.04.
Change In Neuropsychological Functioning: Executive Functioning	Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in cognitive functioning will be evaluated through standardized assessments of executive functioning. The Delis-Kaplan Executive Function Scale (D-KEFS) Trials and Color-Word Tasks was used to measure executive functioning, as measured by Color-Word Inhibition, Color-Word Switching Inhibition, and Trails. Scored using a scaled-score (minimum=1, maximum=19 for all measures). Higher scores indicate better outcome.
Change in Sleep Efficiency as Measured by Polysomnography	Pre-Treatment (0-weeks),Post-Treatment (8-weeks), Follow-Up (12-weeks)	Change in sleep efficiency will be assessed through overnight polysomnographic sleep studies.

Countries

United States

Participant flow

Recruitment details

Number of participants enrolled (73) differs from participants started due to lack of eligibility post consent/baseline or declining continued participation.

Participants by arm

Arm	Count
Cognitive-Behavioral Therapy for Insomnia 6-week manualized treatment designed to improve symptoms of chronic insomnia. 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.	27
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. Sleep Education: Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.	28
Total	55

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	7	5

Baseline characteristics

Characteristic	Cognitive-Behavioral Therapy for Insomnia	Sleep Education	Total
Age, Continuous	37.3 years STANDARD_DEVIATION 6.7	34.75 years STANDARD_DEVIATION 7.1	36.0 years STANDARD_DEVIATION 6.97
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	7 Participants	3 Participants	10 Participants
Sex: Female, Male Male	20 Participants	25 Participants	45 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 27	0 / 28
other Total, other adverse events	0 / 27	0 / 28
serious Total, serious adverse events	0 / 27	0 / 28

Outcome results

Primary

Change in Insomnia Severity

Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome.

Time frame: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

Population: Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Cognitive-Behavioral Therapy for Insomnia	Change in Insomnia Severity	ISI Pre to Post	8.833 score on a scale	Standard Deviation 4.743
Cognitive-Behavioral Therapy for Insomnia	Change in Insomnia Severity	ISI Pre to Follow-Up	9.625 score on a scale	Standard Deviation 5.927
Sleep Education	Change in Insomnia Severity	ISI Pre to Post	7.810 score on a scale	Standard Deviation 7.366
Sleep Education	Change in Insomnia Severity	ISI Pre to Follow-Up	8.364 score on a scale	Standard Deviation 8.25

Secondary

Change in Depressive Symptomatology

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.

Time frame: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

Arm	Measure	Group	Value (MEAN)	Dispersion
Cognitive-Behavioral Therapy for Insomnia	Change in Depressive Symptomatology	PHQ-9 Pre to Post	3.789 score on a scale	Standard Deviation 5.534
Cognitive-Behavioral Therapy for Insomnia	Change in Depressive Symptomatology	PHQ-9 Pre to Follow-Up	3.250 score on a scale	Standard Deviation 5.312
Sleep Education	Change in Depressive Symptomatology	PHQ-9 Pre to Post	1.609 score on a scale	Standard Deviation 4.659
Sleep Education	Change in Depressive Symptomatology	PHQ-9 Pre to Follow-Up	-2.250 score on a scale	Standard Deviation 16.907

Secondary

Change in Pittsburgh Sleep Quality Index

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.