The purpose of this study is to directly compare the effectiveness of two interventions for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for Insomnia (CBTI).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
28 Veterans with chronic insomnia will be randomized to CBTI. The intervention will be delivered in 5 face-to-face session within an 8 week time period. The intervention will be delivered at the VA Pittsburgh Healthcare System. Treatment visits will last approximately 45 minutes.
28 Veterans with chronic insomnia will be randomized to BBTI. The intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3 (option for telephone), and telephone appointments on Weeks 2 and 4. Interventions will be delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit is approximately 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (\<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI) 0-28; 0-7 (no symptoms), 8-14 (sub-threshold symptoms), 15-21 (moderately severe), 22-28 (severe) high scores indicate worse outcome/greater severity
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient Health Questionnaire (PHQ-9)
Patient Health Questionnaire (PHQ-9) 0-27; 0-5 (minimal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate-severe), 21-27 (severe) high scores indicate worse outcome/greater severity
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Generalized Anxiety Disorder (GAD-7)
Generalized Anxiety Disorder (GAD-7) 0-21; 0-5 (minimal), 6-10 (mild), 11-15 (moderate), 16-21 (severe) high scores indicate worse outcome/greater severity
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) 0-76 (sleep item removed), higher scores indicate greater PTSD severity \>33, likely PTSD diagnosis
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
PROMIS Fatigue Scale 33.4 - 76.8 (T-score) The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a participant with a T-score of 50 is equal to the mean and a T-score of 40 is one SD below the mean. Scores less than 50 indicate less fatigue symptoms than an age and gender matched healthy population and scores greater than 50 indicate greater fatigue symptoms than an age and gender matched healthy population.
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
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Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
PROMIS Global Health Physical Health: 16.2 - 67.7 (T-score) Mental Health: 21.2 - 67.6 (T-score) The T-score re-scales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a participant with a T-score of 50 is equal to the mean and a T-score of 40 is one SD below the mean. Scores less than 50 indicate worse quality of life than an age and gender matched healthy population and scores greater than 50 indicate better quality of life than an age and gender matched healthy population.
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Work and Social Adjustment Scale (WSAS)
Work and Social Adjustment Scale (WSAS) 0-40 higher scores indicate worse functioning
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) 0-21 higher score indicates worse sleep quality, \>5 indicates poor quality sleep
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Epworth Sleepiness Scale (ESS)
Epworth Sleepiness Scale (ESS) 0-24 higher score indicates greater sleepiness, \>10 indicates excessive daytime sleepiness
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Dysfunctional Beliefs and Attitudes About Sleep (DBAS)
Dysfunctional Beliefs and Attitudes About Sleep (DBAS) 0-160 reported as mean score (sum of items answered / 10 for a range 0-16) higher scores indicate greater dysfunctional beliefs and attitudes
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) 1-7 higher score indicative of greater subjective improvement
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary
The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Onset Latency (SOL) - lower is better Wake After Sleep Onset (WASO) - lower is better Early Morning Awakenings (EMA) - lower is better Total Wake Time (TWT) - lower is better Total Sleep Time (TST) - higher is better Time in Bed (TIB) - value depends on TWT and TST
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary - Sleep Efficiency
The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Efficiency (total sleep time \[TST\] / time in bed \[TIB\]) x 100 - higher is better
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)
Sleep Diary - Sleep Quality
The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors Sleep Quality (SQ) 1-5 higher is better
Time frame: post-treatment (BBTI: week 5; CBTI: week 6-9)