Background
Chronic insomnia—difficulty initiating and maintaining sleep that persists for more than 3 months—is a prevalent disorder among adults, approximately 25%, but can be particularly pervasive among military personnel and Veterans, with estimates nearing 75% in some samples [
1‐
5]. Chronic insomnia is among the most reported complaints of Veterans [
6] and is the most common initial complaint of military personnel referred for mental health services [
1,
7]. Potential risk factors include deployment overseas, engaging in combat, 24 hours/7 days a week work schedules, adjusting to separation from military and reintegration to civilian life, as well as the numerous medical and mental health problems that commonly affect military personnel and Veterans [
8‐
13]. It is also a risk factor for the development of depression [
14] and metabolic and cardiovascular diseases [
15]. Furthermore, insomnia is associated with significant healthcare utilization, and both individual and societal economic burden [
16‐
19].
Despite the significant impact of insomnia, it remains undertreated [
20]. When identified, it is most often treated in primary care with pharmacotherapy, rather than the first-line recommendation, Cognitive Behavioral Therapy for Insomnia (CBTI) [
21,
22]. Pharmacotherapy is associated with risks of dependence, tolerance, and poorer quality sleep [
23‐
25], whereas evidence-based psychotherapies for primary and comorbid insomnia results in better long-term outcomes, no drug dependence or polypharmacy risk, and potential cost savings [
26,
27]. Based on our experience, numerous system-, provider-, and patient-level factors contribute to the gap between the high prevalence of insomnia and the relatively low use of CBTI, and potentially contribute to the high use of prescription medications: (1) shortage of CBTI-trained clinicians; (2) treatment restricted to mental health clinics; (3) insomnia being considered a symptom of another disorder; (4) lack of patient and provider knowledge regarding CBTI availability; (5) barriers to attend appointments such as distance to travel, work schedule, and childcare; and (6) burdensome duration and delivery method (CBTI can be six or more in-person, 45-min sessions).
The Department of Veterans Affairs (VA) nationwide CBTI rollout, which began in 2011, substantially increased the number of providers who can deliver evidence-based treatment with fidelity and helped to increase access to care. An evaluation of 696 Veterans who participated as part of the CBTI rollout found that 60% who completed treatment had insomnia severity reductions, per the Insomnia Severity Index (ISI), of ≥ 8 points (mean change 20.7 to 10.9), with a pre- to post-treatment Cohen’s
d effect size of 2.3 [
28,
29]. While the rollout has been successful to date and continues to train providers, CBTI is still only being delivered to a fraction of those who could benefit. Thus, in order to increase the viability of cognitive and/or behavioral insomnia treatments in the VA, it is critical to not only determine which treatments are most effective, but also to determine which implementation factors (e.g., barriers and facilitators) most impact the uptake of these treatments by patients and providers in routine clinical practice. An evidence-based behavioral insomnia treatment that combines brevity (four sessions or fewer), multiple delivery modalities (in-person and phone), and is delivered by non-physician, non-sleep-specialist clinicians may help to overcome barriers associated with the current standard of care treatment, CBTI. However, the four weekly sessions of Brief Behavioral Treatment for Insomnia (BBTI) [
30,
31] (two in-person, two phone calls), focused on the behavioral aspects of CBTI, have also proven to be efficacious among Veterans [
32], and are potentially easier to implement in primary care settings because this approach is shorter and requires less training to deliver competently. Thus, BBTI could be an ideal intervention for delivery in the context of co-located, collaborative, integrated primary care within the VA, which employs a variety of providers of differing training levels.
Uptake of BBTI into primary care could effectively and efficiently increase access to insomnia treatment and potentially decrease some of the risks and burdens associated with chronic insomnia. However, it is necessary to determine whether BBTI offers non-inferior treatment outcomes to CBTI. Additionally, given that the implementation factors associated with BBTI and CBTI are not well known, it is also important to determine whether BBTI experiences fewer patient-, provider-, and system-level barriers to implementation than CBTI. Therefore, the current proposal utilizes a hybrid type I research design that includes: (1) a pilot comparative effectiveness trial of BBTI versus CBTI and (2) a qualitative needs assessment of healthcare provider- and Veteran-level implementation factors guided by the Consolidated Framework for Implementation Research (CFIR), the predominant model of implementation factors [
33].
Discussion
As CBTI continues to be disseminated to providers across the VA, it is increasingly important to better understand barriers to, and facilitators of, successful implementation of insomnia treatment in order to ensure that Veterans have the best access to care. Furthermore, it is important to evaluate the potential for new avenues of treatment delivery, like BBTI, that can benefit Veterans who may not have adequate access to specialty mental health providers trained in CBTI. As described above, this hybrid type I project preliminarily tests the clinical non-inferiority of a briefer, primary care-friendlier treatment, BBTI, versus the current “gold standard” treatment for insomnia, CBTI. Furthermore, utilizing CFIR-guided qualitative interviews with primary care providers and nurses, this project also seeks to identify key perceived barriers to, and facilitators of, implementing BBTI, or similar treatments, into the primary care setting in order to improve access to care. For Veterans, the interviews will help to understand their experiences in care and their care preferences. These are two of the strengths of this hybrid type I project.
Additionally, if the clinical trial is successful, and BBTI is shown to be non-inferior to CBTI, there may be a pathway toward broader training of BBTI as a complementary treatment to CBTI, with training focused on primary care staff like nurses and social workers, especially in settings where psychologists are not easily accessible or available (e.g., community-based outpatient clinics). Alternatively, even if BBTI is not found to be non-inferior to CBTI, there are still several directions to pursue. For example, if BBTI is not non-inferior to CBTI but still results in a significant treatment response for some Veterans, BBTI may still be appropriate for widespread dissemination and play an important role in stepped-care treatment for insomnia throughout VA. Also, by conducting a hybrid trial, the process of implementing high-quality, evidence-based practices, like BBTI, may be accelerated by the valuable input gained through qualitative interviews with both providers and Veterans. The qualitative interviews afford the participants the opportunity to provide in-depth information about their perspectives and insights about improving access to care, including advantages, disadvantages, and ways to succeed and the potential pitfalls to avoid from the frontline clinicians, and the open-ended interview structure allows for participant-directed responses. The perspectives of providers and Veterans on how to successfully implement BBTI into primary care settings can help guide the development of methods around identified barriers. Lastly, our multidisciplinary team has the broad spectrum of health services expertise needed to conduct this research, including health psychology, behavioral sleep medicine, implementation science, and qualitative and quantitative methods. The team members can make a substantive contribution to what is known about the implementation of behavioral treatments for insomnia in the primary care setting and improving access to care for Veterans with chronic insomnia.
While this study has potential to improve access to care for Veterans with chronic insomnia, it is not without limitations. The study site is a single, urban VAMC that is currently adequately staffed to manage its Veterans with insomnia. This may limit the generalizability of results for both study aims, not only among other VAMCs but also for the general community. Conducting a multisite hybrid trial may have helped to solve these limitations and may be an appropriate design for future studies to confirm, expand, or explore alternatives based on the current study’s findings. In regards to limitations of qualitative research, the goal is not generalizability in a statistical sense, but it is important to assess the ability of the proposed research to generate findings with utility beyond merely describing the specific study settings and sample. Qualitative research has been shown to produce fine-grained and rich descriptive analysis not achievable with purely quantitative approaches, and generate hypotheses and theoretical insights that can be usefully extrapolated, tested, and implemented beyond the specific study settings and sample. Given the current lack of empirical data on BBTI versus CBTI as well as implementing brief behavioral treatments into the primary care setting, we argue that a qualitative approach to identifying providers’ perceived barriers to, and facilitators and Veterans’ experiences of, treatment and preferences for care, is well justified and will make a significant contribution to the existing knowledge base. We have chosen to include a primary care providers (i.e., physicians, physician assistants, and nurse practitioners), nurses (registered nurse care managers and licensed practical nurses), and Veterans in hopes of increasing variation in the perspectives of valuable stakeholders and maximizing our ability to identify a more exhaustive list of barriers to, and facilitators of, implementation.
CBTI currently has significant support as the recommended first-line treatment for chronic insomnia for adults [
34]. Still, there is much work to be done to provide effective and accessible insomnia care to Veterans, as well as the general community, and the results of this hybrid study may help reach those goals.
Acknowledgements
We would like to acknowledge and thank study consultants (Charles Atwood, Kelly Burkitt, Laura Damschroder, Gretchen Haas, Rachel Manber, Andrew Pomerantz, and Susan Zickmund), clinicians (Alyssa Ford, Jebediah Northern, Danielle Novick, Caitlan Tighe, and Jody Tomko), and research staff (Casey Carl, Molly Daley, and Lisa Lederer) for their contributions and assistance on this project.