Implementation of Brief Insomnia Treatments - Clinical Trial

Cognitive Behavioral Therapy for Insomnia (CBTI) is the evidence-based first line treatment
for chronic insomnia. Randomized controlled trials and meta-analyses have established that
CBTI is efficacious and effective. Despite the strong evidence for CBTI, chronic insomnia
remains under-treated among Veterans because of several barriers that limit access to
behavioral treatments. In recent years, the VA has taken substantial measures to train more
clinicians to provide insomnia treatment; however, a deficit in treatment availability
remains. In 2011, the VA began to train clinicians in CBTI as part of the VA's Evidence Based
Psychotherapy (EBP) training program, with a goal to train 1000 clinicians. Even with 1000 VA
clinicians trained in CBTI, a shortage of clinicians will likely remain due to the high
prevalence of insomnia. High prevalence and a shortage of clinicians prevent the VA from
meeting the care demand of Veterans with insomnia. While the CBTI roll-out is a significant
investment from the VA, additional mechanisms, such as dissemination and implementation of
other evidence-based treatments for insomnia with fewer implementation barriers, must be
considered to address the high prevalence of insomnia.

The in-person delivery and length of treatment for CBTI may be one of barriers to accessing
care. Briefer protocols that use multiple delivery modalities have recently been developed
and may help to increase session attendance and treatment completion. These shorter insomnia
treatments are often referred to as Brief Behavioral Treatment for Insomnia (BBTI) and
consist of ≤4 sessions. Besides fewer and briefer sessions, and utilizing both in-person and
phone delivery of treatment, BBTI also emphasizes the behavioral components of CBTI (i.e.,
stimulus control and sleep restriction) rather than a combined approach focusing on both
behavioral and cognitive components. BBTI is efficacious in adults—studies with older adults
and Veterans found BBTI resulted in a significant decrease in insomnia severity with Cohen's
d effect sizes in the moderate to large range. Like CBTI, BBTI significantly improves
insomnia severity and may also help to improve secondary outcomes like depression and
anxiety.

Integration of newer insomnia treatments, like BBTI, will first depend on establishing its
evidence directly compared to CBTI. Effectiveness trials of BBTI, especially those conducted
with military Veterans in typical VA settings, have yet to be conducted. Before BBTI can be
broadly implemented and integrated into the VA, it needs to be established as a clinically
effective treatment for insomnia among Veterans and a statistically non-inferior treatment
(not necessarily better or worse) for Veterans compared to CBTI.

Inclusion Criteria:

1. Age 18 years old and older

2. Military Veteran

3. Insomnia Severity Index (ISI) ≥15 & DSM-5 criteria for insomnia disorder

4. If using sleep medications, medication and dosage have not been changed in the past
month, and will remain unchanged for the duration of the treatment phase of the study
(i.e., 4-8 weeks)

5. If using other psychotropic medications, medication and dosage have not been changed
in the past 2 months, and will remain unchanged for the duration of the treatment
phase of the study (i.e., 4-8 weeks)

Exclusion Criteria:

1. Untreated, current, and severe PTSD as determined by the Structured Clinical Interview
for DSM-5 (SCID)

2. Untreated, current, and severe Major Depressive Disorder as determined by the SCID

3. Current/Past Psychotic or Bipolar disorder

4. Current substance or alcohol use disorder as determined by the SCID

5. Current unstable medical condition

6. Hospitalization in the previous 1 month for a medical condition or surgery for which
recovery overlaps with the study onset and duration

7. Seizure disorder, open skull brain injury, or moderate to severe traumatic brain
injury (TBI)

8. Current, untreated, sleep disorders such as nightmare disorder, restless legs
syndrome, circadian rhythm disorder (or shift work), or a suspected sleep disorder
requiring polysomnographic assessment, such as obstructive sleep apnea or periodic leg
movements as determined by the South Texas Research Organizational Network Guiding
Studies on Trauma and Resilience (STRONG STAR) Clinical Interview for DSM-5 Sleep-Wake
Disorders and/or the STOP-BANG questionnaire

9. Moderate to severe cognitive impairment (St. Louis University Mental Status [SLUMS]
exam ≤20) and/or diagnosis in medical record indicative of moderate to severe
cognitive impairment

10. Unstable environment that is not in one's control (e.g., homeless, temporary group
home, care taking duties at night)

11. Pregnancy and/or breast-feeding