Persistent primary insomnia (PPI) is a prevalent and debilitating sleep disorder which, in middle-aged and older adults is characterized by an unrelenting difficulty maintaining sleep. Available sedative hypnotic medications may provide PPI patients some short-term relief but such agents fail to address the underlying behavioral/psychological factors which perpetuate PPI. Over the past decade we have developed, refined, and repeatedly tested a cognitive-behavioral therapy (CBT) for the treatment of sleep-maintenance difficulties. Our most recent results show CBT-treated patients significantly more often achieve a priori- defined criterion levels of improvement than do those receiving either a behavioral placebo or relaxation therapy (RT). During our currently funded trial (Grant number MH 48187) we have begun to explore CBT's dose-response curve (i.e., number of treatment sessions and time in treatment vs. outcome) and have observed that: (1) PPI patients are more likely to achieve stable levels of sleep improvement following multiple CBT sessions than following one CBT session; and (2) a subset of patients (we call Type 1 insomniacs) who report relatively low self- efficacy in regard to sleep, view sleep as relatively unpredictable/ uncontrollable and have relatively elevated concerns about their insomnia prior to treatment, show stable gains following one CBT session. The proposed project's Specific Aims/Major Objectives entail conducting a prospective randomized clinical trial to confirm these findings. One arm of this study's 5 x 2 x 11 factorial design will compare 1,2,4 and 8 therapist-guided sessions of CBT with a waiting list condition. The second arm of the design will compare treatment-related improvements of pre-identified Type 1 insomniacs with improvements shown by our remaining subjects (herein called Type II insomniacs). The final arm is a repeated-measures factor consisting of 11 time points (i.e. baseline, weekly during treatment, and 2 follow-up periods) at which sleep changes are assessed. Subjects will be assessed at all 11 time points with sleep logs, wrist actigraphy, an Insomnia Symptom Questionnaire, a Sleep Efficacy Scale, and the State-Trait Anxiety and Beck Depression Scales. These assessments will be used to determine change/improvements in subjective/objective sleep measures, global insomnia symptoms and general mood states. Multivariate statistics and tests of clinical significance will be conducted with these various measures. Analyses will also be conducted to assess the separate contributions of such treatment dosing factors as the number of therapist contacts received and the time given to subjects for treatment implementation. Results should provide information which helps us to more accurately titrate the dose of CBT treatment with different patient types. We should also develop a better understanding of the time course over which treatment-related improvements might be expected for insomniacs in general and for specific primary insomniac subtypes.
