Trial Outcomes & Findings for Cognitive-Behavioral Therapy for Veterans With TBI (NCT NCT02658669)
NCT ID: NCT02658669
Last Updated: 2024-09-25
Results Overview
Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome.
COMPLETED
NA
73 participants
Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
2024-09-25
Participant Flow
Number of participants enrolled (73) differs from participants started due to lack of eligibility post consent/baseline or declining continued participation.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=27 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 6.7 • n=27 Participants
|
34.75 years
STANDARD_DEVIATION 7.1 • n=28 Participants
|
36.0 years
STANDARD_DEVIATION 6.97 • n=55 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=27 Participants
|
3 Participants
n=28 Participants
|
10 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=27 Participants
|
25 Participants
n=28 Participants
|
45 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change in Insomnia Severity
ISI Pre to Post
|
8.833 score on a scale
Standard Deviation 4.743
|
7.810 score on a scale
Standard Deviation 7.366
|
|
Change in Insomnia Severity
ISI Pre to Follow-Up
|
9.625 score on a scale
Standard Deviation 5.927
|
8.364 score on a scale
Standard Deviation 8.250
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change in Depressive Symptomatology
PHQ-9 Pre to Post
|
3.789 score on a scale
Standard Deviation 5.534
|
1.609 score on a scale
Standard Deviation 4.659
|
|
Change in Depressive Symptomatology
PHQ-9 Pre to Follow-Up
|
3.250 score on a scale
Standard Deviation 5.312
|
-2.250 score on a scale
Standard Deviation 16.907
|
SECONDARY outcome
Timeframe: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)Population: Difference in overall number of participants and number analyzed differs due to lack of completion of treatment. Overall number refers to those who were assessed at week-0 treatment.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change in PTSD Stressor Specific Checklist 5
PCL-5 Pre to Post
|
8.053 score on a scale
Standard Deviation 13.373
|
6.227 score on a scale
Standard Deviation 10.497
|
|
Change in PTSD Stressor Specific Checklist 5
PCL-5 Pre to Follow-Up
|
3.125 score on a scale
Standard Deviation 12.822
|
4.727 score on a scale
Standard Deviation 11.516
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change in World Health Organization Disability Assessment Scale-2
WHODAS Pre to Post
|
-0.316 score on a scale
Standard Deviation 25.478
|
1.818 score on a scale
Standard Deviation 14.702
|
|
Change in World Health Organization Disability Assessment Scale-2
WHODAS Pre to Follow-Up
|
17.200 score on a scale
Standard Deviation 18.754
|
8.273 score on a scale
Standard Deviation 19.032
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index
PSQI Pre to Post
|
5.412 score on a scale
Standard Deviation 3.183
|
4.400 score on a scale
Standard Deviation 3.633
|
|
Change in Pittsburgh Sleep Quality Index
PSQI Pre to Follow-Up
|
5.125 score on a scale
Standard Deviation 2.748
|
4.833 score on a scale
Standard Deviation 4.821
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain
PROMIS Pre to Post
|
-0.8333 score on a scale
Standard Deviation 4.4042
|
3.3778 score on a scale
Standard Deviation 5.4668
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain
PROMIS Pre to Follow-Up
|
-2.5714 score on a scale
Standard Deviation 5.1768
|
2.050 score on a scale
Standard Deviation 2.1581
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change in Neuropsychological Functioning: Attention/Processing Speed
Coding WAIS Pre to Follow-Up
|
-2.600 score on a scale
Standard Deviation 2.608
|
-1.100 score on a scale
Standard Deviation 3.784
|
|
Change in Neuropsychological Functioning: Attention/Processing Speed
Symbol Search WAIS Pre to Post
|
-1.90 score on a scale
Standard Deviation 3.035
|
-0.882 score on a scale
Standard Deviation 2.395
|
|
Change in Neuropsychological Functioning: Attention/Processing Speed
Symbol Search WAIS Pre to Follow-Up
|
-3.400 score on a scale
Standard Deviation 2.302
|
-1.200 score on a scale
Standard Deviation 3.765
|
|
Change in Neuropsychological Functioning: Attention/Processing Speed
Coding WAIS Pre to Post
|
-0.667 score on a scale
Standard Deviation 1.000
|
-1.500 score on a scale
Standard Deviation 2.875
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change In Neuropsychological Functioning: Verbal Learning and Memory
HVLT Total Pre to Post T-Score
|
-0.111 score on a scale
Standard Deviation 8.937
|
-1.099 score on a scale
Standard Deviation 10.228
|
|
Change In Neuropsychological Functioning: Verbal Learning and Memory
HVLT Total Pre to Follow-Up T-Score
|
-4.200 score on a scale
Standard Deviation 10.426
|
-8.200 score on a scale
Standard Deviation 7.613
|
|
Change In Neuropsychological Functioning: Verbal Learning and Memory
HVLT Delayed Pre to Post T-Score
|
-4.556 score on a scale
Standard Deviation 7.485
|
-7.300 score on a scale
Standard Deviation 14.914
|
|
Change In Neuropsychological Functioning: Verbal Learning and Memory
HVLT Delayed Pre to Follow-Up T-Score
|
-3.200 score on a scale
Standard Deviation 9.985
|
-12.000 score on a scale
Standard Deviation 13.030
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cognitive-Behavioral Therapy for Insomnia
n=26 Participants
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.
|
Sleep Education
n=28 Participants
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.
|
|---|---|---|
|
Change In Neuropsychological Functioning: Executive Functioning
DKEFS Color-Word Inhibition Pre to Post
|
-1.333 score on a scale
Standard Deviation 1.803
|
-0.850 score on a scale
Standard Deviation 2.412
|
|
Change In Neuropsychological Functioning: Executive Functioning
DKEFS Color-Word Inhibition Pre to Follow-Up
|
-1.400 score on a scale
Standard Deviation 2.074
|
-0.700 score on a scale
Standard Deviation 1.494
|
|
Change In Neuropsychological Functioning: Executive Functioning
DKEFS Color Word Inhibition Switching Pre to Post
|
-1.667 score on a scale
Standard Deviation 1.581
|
-1.850 score on a scale
Standard Deviation 2.059
|
|
Change In Neuropsychological Functioning: Executive Functioning
DKEFS Color Word Inhibition Switching Pre to Follow-Up
|
-1.00 score on a scale
Standard Deviation 1.581
|
-2.200 score on a scale
Standard Deviation 2.530
|
|
Change In Neuropsychological Functioning: Executive Functioning
DKEFS Trails Pre to Post
|
-0.667 score on a scale
Standard Deviation 1.581
|
-0.353 score on a scale
Standard Deviation 1.169
|
|
Change In Neuropsychological Functioning: Executive Functioning
DKEFS Trails Pre to Follow-Up
|
-1.400 score on a scale
Standard Deviation 2.074
|
-0.700 score on a scale
Standard Deviation 1.418
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-Treatment (0-weeks),Post-Treatment (8-weeks), Follow-Up (12-weeks)Population: Data not collected due to pandemic.
Change in sleep efficiency will be assessed through overnight polysomnographic sleep studies.
Outcome measures
Outcome data not reported
Adverse Events
Cognitive-Behavioral Therapy for Insomnia
Sleep Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place