Older adults with chronic insomnia treated with BBTI showed clinically and statistically significant improvement in sleep outcomes at 4 weeks compared with participants treated with IC. The superiority of BBTI was seen for outcomes based on categorically defined criteria, presence of insomnia disorder, number needed to treat, retrospective clinical ratings, sleep diary, and actigraphy but not PSG. Various clinical subgroups did not show differential effects, and treatment gains were maintained at 6 months. The BBTI delivered by a nurse clinician may be an efficacious and practical treatment for chronic insomnia in older adults.
Differences in specific inclusion and exclusion criteria and study instruments make it difficult to compare the magnitude of treatment effects across behavioral treatment studies of insomnia. The improvements seen with BBTI appear similar to those observed with traditional CBTI in middle-aged populations, although somewhat smaller in magnitude,16,23
and comparable in magnitude to those reported for CBTI and other behavioral treatments in older adults.24,45,48
For instance, a meta-analysis of CBTI and behavioral interventions for insomnia in older adults reported mean effects sizes of 0.60, 0.51, 0.19, 0.38, and 0.73 for diary outcomes of sleep quality, SOL, TST, SE, and WASO, respectively.21
Corresponding values in the current study were 0.62, 0.96, 0.13, 0.80, and 0.59, respectively. Like most CBTI studies, we found an initial reduction in TST concurrent with improvements in SE and other sleep ratings. The TST increased at 6-month follow-up, when initial sleep restriction was relaxed. The magnitude of BBTI effects is also similar to that found for BZRA medications.49
We did not observe the significant treatment effects on PSG observed in some behavioral treatment studies.45,50,51
This could result from the shorter duration of BBTI compared with CBTI or from differences in participant age, inclusion criteria, sampling strategies and biases, acute treatment duration, and the use of laboratory vs in-home PSG.52,53
Actigraphy and in-home PSG relied in part on self-reported data to identify bed time, which could lead to some inaccuracy in these “objective” measures. In our study as in most others, both sleep disturbances and treatment improvement were larger for self-reports than for PSG measures in patients with insomnia23,54
; this discrepancy may be a fundamental characteristic of insomnia.55
Currently, there are no universally accepted criteria for categorical treatment outcomes in insomnia studies. 46
Our criteria included a general measure of sleep quality (PSQI) and a widely used summary sleep diary metric in behavioral treatment studies of insomnia (SE). The magnitude of change used to define response corresponded to a large effect size, was consistent with changes reported in published studies, and corresponded to the minimally important difference in the ISI (eAppendix). Other categorical treatment outcomes, such as 50% reduction in sleep diary values50
or changes in the ISI score to “normal” values, have been used in other studies.51
Our acute response and remission rates (41% [n=16] and 26% [n=10]) were lower than those found in studies using the ISI as an outcome measure in a 6-week CBTI study (59.5 and 39%)51
but similar to those reported in a study of older adults using 85% diary SE as a criterion.45
Our study may have underestimated treatment effects because we did not alter the 1-month reporting frame of the PSQI for posttreatment outcomes. However, confidence in our outcomes is increased by convergent findings when we used the presence or absence of insomnia diagnosis as a criterion.
Our findings can also be placed in the context of other studies aimed at the dissemination of behavioral insomnia treatments. The magnitude of observed sleep diary changes was comparable to magnitudes reported for an abbreviated form of CBTI in a primary care,56
group CBTI delivered in primary care practices,57,58
and CBTI provided to patients with medical comorbidities.59
Brief, nurse-administered behavioral and cognitive behavioral treatments appear to be feasible and efficacious for older adults with comorbid insomnia. Other novel forms of behavioral treatment delivery such as Internet programs may also be efficacious.60
Thus, a range of options is now available to administer behavioral treatments for insomnia across a range of clinical settings.
Although BBTI shares many features with other behavioral insomnia treatments, some particular features make it an especially attractive option. First, it has a strong behavioral focus, which may avoid some of the perceived stigma associated with “psychological” treatments in medical settings. Second, it is overtly linked to a physiologic model of sleep regulation,28
which provides a sound empirical rationale for both patients and physicians. Third, it provides patients with a workbook and specific written prescriptions for sleep behaviors. Fourth, it is simple enough to be taught in a short amount of time to nurses, who are often responsible for behavioral health management in primary care offices. Finally, it appears to have comparable efficacy to established treatments. Thus, BBTI possesses efficacy, efficiency, and acceptability—3 characteristics of a successful “entry level” treatment in a stepped care approach to behavioral management of insomnia.61
Strengths of this study included convergent self-report, observer-rated, and physiologic outcomes and a sample that is generalizable to practice settings. Limitations included a control condition that was not matched for therapist time, the use of a single therapist for both conditions, or a limited follow-up interval. The control condition was selected to represent an ecologically valid comparison for primary care settings, where sleep and insomnia are infrequently addressed and behavioral treatment is rarely available. The use of a single therapist was likely to be less problematic for a control condition that, by design, consisted of self-education. Finally, longer follow-up in both intervention groups might have been informative. Our follow-up strategy was based on our conceptual model of insomnia treatment in primary care: if behavioral treatment cannot be delivered in a brief format with rapid results, patients are likely to proceed to pharmacologic treatment. Finally, 68% of our insomnia patients had an apnea-hypoxia index higher than 5, raising the possibility that treatment for apnea could further enhance outcomes.
In summary, BBTI produced statistically and clinically meaningful improvements that were sustained for 6 months. Future studies should examine the feasibility of educating nurses and other health professionals in BBTI and the effectiveness of BBTI delivered in actual practice settings on symptom-based, functional, and health care economic outcomes.