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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBTI | Experimental | Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I) |
|
| ABTI | Experimental | Arousal-Based Therapy for Insomnia (ABT-I) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I | Behavioral | Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline at week 8 after treatment |
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Inclusion Criteria:
Exclusion Criteria:
Sleep-Related
Neuropsychiatric
Medical
- Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if < 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months. Unstable adult onset diabetes will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Ansgar J. Furst, PhD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CBTI | Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I) During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes. This therapy addresses thoughts and behaviors that can interfere with sleep. Thoughts and behaviors that develop in response to insomnia can result in heightened anxiety about sleep and the development of coping strategies that can ultimately worsen insomnia. This therapy aims to alter behaviors that contribute to sleep problems, and correct the beliefs that drive those behaviors. Therapy will also include sleep education. |
| FG001 | ABTI | Arousal-Based Therapy for Insomnia (ABT-I) During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes. This therapy addresses the heightened state of alertness or anxiety that can occur when experiencing difficulty sleeping. This heightened state of arousal develops over time in response to insomnia, and can make falling asleep more difficult. Since this response is learned, it can also be unlearned. This therapy teaches skills to reduce the heightened arousal that contributes to insomnia. Therapy will also include sleep education. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBTI | Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I) CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| BG001 | ABTI | Arousal-Based Therapy for Insomnia (ABT-I) ABT-I: Arousal-Based Therapy for Insomnia (ABT-I) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 110 participants who were randomized, only participants who completed the end of treatment Insomnia Severity Index survey were included in this analysis. | Posted | Mean | Standard Deviation | Units on a scale | Change from baseline at week 8 after treatment |
|
Adverse Events were collected at weeks 1, 2, 3, 4, 5, 6, 7, 8 and at 6 months.
At each visit, participants were asked about any new medical visits, physical complaints, medical procedures, changes in mood, or accidents/near misses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBTI | Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I) CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ansgar Furst; Rayma Williams | VA Palo Alto | (650) 339-4015 | ansgar.furst@va.gov; rayma.williams@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 27, 2024 | Sep 27, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
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| ABT-I |
| Behavioral |
Arousal-Based Therapy for Insomnia (ABT-I) |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | ABTI | Arousal-Based Therapy for Insomnia (ABT-I) During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes. This therapy addresses the heightened state of alertness or anxiety that can occur when experiencing difficulty sleeping. This heightened state of arousal develops over time in response to insomnia, and can make falling asleep more difficult. Since this response is learned, it can also be unlearned. This therapy teaches skills to reduce the heightened arousal that contributes to insomnia. Therapy will also include sleep education. |
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | ABTI | Arousal-Based Therapy for Insomnia (ABT-I) ABT-I: Arousal-Based Therapy for Insomnia (ABT-I) | 0 | 39 | 0 | 39 | 0 | 39 |
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| D001523 |
| Mental Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |