Insomnia, Traumatic Brain Injury
Conditions
Keywords
Insomnia, Traumatic Brain Injury, Cognitive Behavioral Therapy, Veterans
Brief summary
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).
Detailed description
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).
Interventions
BEHAVIORALCBT-I
Cognitive Behavioral Therapy for Insomnia (CBT-I)
BEHAVIORALABT-I
Arousal-Based Therapy for Insomnia (ABT-I)
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female Veterans of any racial or ethnic group * Independent Living (not in nursing home or VA Extended Care facility) * Diagnosis of insomnia using the Duke structured interview * Male or female chronic (\>3 months since injury) mild Traumatic Brain Injury (mTBI). * Subjects with PTSD will be included in this study as long as they do not meet criteria for depression described below. * Use of CNS active medications that could significantly impact sleep or alertness is allowed as long as the dose, timing, and formulation are stable (≥ 3 weeks). * Stable adult onset diabetes, controlled with insulin, oral medications or diet is acceptable. * Use of medications, drugs, herbal remedies, or hormones specifically prescribed for treating sleep disturbances is allowed as long as the dose, timing, and formulation are stable (≥ 3 weeks). * Subjects will be assessed for sleep apnea risk by the Berlin Questionnaire. Those with responses suggestive of high risk for apnea will be referred to Pulmonary Medicine for standard clinical screening, but will not be excluded. If subjects with obstructive sleep apnea are using CPAP, we will require stable use throughout the study.
Exclusion criteria
Sleep-Related * Excessive caffeine consumption (≥ 5 cups of coffee per day) and unable to reduce to ≤ 3 cups before lunch a day for ≥ 3 weeks prior to treatment. * Subjects working a rotating shift or an unconventional daytime shift (ending after 1700 h, expected to be rare in the age group we are studying) will be ineligible. Neuropsychiatric * Current or lifetime history of a psychiatric disorder with primary psychotic features. * Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation. * Current or within the past 30 days: drug abuse or dependence (except nicotine). * Current or expected cognitive behavior therapy for another condition (e.g. depression). * More than one glass of wine or beer with dinner scheduled at least 3 to 4 hours before bedtime. - Presence of any acute or unstable psychiatric condition(s) that requires referral for treatment. * Folstein Mini-Mental State Exam (MMSE) \< 24. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Change from baseline at week 8 after treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBTI Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I) | 56 |
| ABTI Arousal-Based Therapy for Insomnia (ABT-I)
ABT-I: Arousal-Based Therapy for Insomnia (ABT-I) | 54 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 7 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | CBTI | ABTI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 11 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 43 Participants | 94 Participants |
| Age, Continuous | 49.95 years STANDARD_DEVIATION 10.32 | 52.56 years STANDARD_DEVIATION 12.6 | 51 years STANDARD_DEVIATION 11.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 47 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 38 Participants | 85 Participants |
| Sex: Female, Male Female | 15 Participants | 17 Participants | 32 Participants |
| Sex: Female, Male Male | 41 Participants | 37 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 39 |
| other Total, other adverse events | 0 / 47 | 0 / 39 |
| serious Total, serious adverse events | 0 / 47 | 0 / 39 |
Outcome results
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.
Time frame: Change from baseline at week 8 after treatment
Population: Of the 110 participants who were randomized, only participants who completed the end of treatment Insomnia Severity Index survey were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBTI | Insomnia Severity Index (ISI) | -9.7 Units on a scale | Standard Deviation 4.42 |
| ABTI | Insomnia Severity Index (ISI) | -4.72 Units on a scale | Standard Deviation 4.5 |