An interventional study of CBT-I and ABT-I in Insomnia and Traumatic Brain Injury, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).
Insomnia is a serious health problem in Veterans suffering from chronic Traumatic Brain Injury (TBI) and often associated with extensive prescription of sleeping medications. Although safer, even the latest "sleeping pills" can lead to daytime impairment and risk of abuse. Thus non-pharmacological treatments for insomnia have been pursued as alternatives to medications. This trial will compare the relative efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Arousal-Based Therapy for Insomnia (ABT-I).
Exclusion Criteria:
Sleep-Related
Neuropsychiatric
Medical
Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral: CBT-I
Arousal-Based Therapy for Insomnia (ABT-I)
Behavioral: ABT-I
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Arousal-Based Therapy for Insomnia (ABT-I)
Insomnia Severity Index (ISI)
The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.
Time frame: Change from baseline at week 8 after treatment
| Milestone | CBTI | ABTI |
|---|---|---|
| Started | 56 | 54 |
| Completed | 47 | 39 |
| Not completed | 9 | 15 |
| Withdrew: Lost to follow-up | 6 | 7 |
| Withdrew: Protocol violation | 1 | 4 |
| Withdrew: Withdrawal by subject | 1 | 4 |
| Withdrew: Physician decision | 1 | 0 |
The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.
| Units on a scale | CBTI | ABTI |
|---|---|---|
| Insomnia Severity Index (ISI) | -9.7 ± 4.42 | -4.72 ± 4.5 |
Collected over Adverse Events were collected at weeks 1, 2, 3, 4, 5, 6, 7, 8 and at 6 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CBTI | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| ABTI | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Age, Categorical(Participants) | CBTI | ABTI | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 43 | 94 |
| >=65 years | 5 | 11 | 16 |
| Age, Continuous(years) | CBTI | ABTI | Total |
|---|---|---|---|
| Mean | 49.95 ± 10.32 | 52.56 ± 12.60 | 51 ± 11.52 |
| Sex: Female, Male(Participants) | CBTI | ABTI | Total |
|---|---|---|---|
| Female | 15 | 17 | 32 |
| Male | 41 | 37 | 78 |
| Ethnicity (NIH/OMB)(Participants) | CBTI | ABTI | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 7 | 12 |
| Not Hispanic or Latino | 49 | 47 | 96 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | CBTI | ABTI | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 4 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 6 | 7 |
| White | 47 | 38 | 85 |
| More than one race | 4 | 6 | 10 |
| Unknown or Not Reported | 0 | 2 | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data will be shared through the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system: This system was developed to share data across the entire TBI research field and to facilitate collaboration between laboratories, as well as interconnectivity with other informatics platforms. Data will be uploaded to FITBIR according to the detailed instructions available on the FITBIR website.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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