A Computerized Cognitive behavioral therapy Randomized, Controlled, pilot trial for insomnia in Parkinson Disease (ACCORD-PD)

Abstract

BackgroundParkinson disease (PD) is associated with a high prevalence of insomnia, affecting up to 88% of patients. Pharmacotherapy studies in the literature addressing insomnia in PD reveal disappointing and inconsistent results. Cognitive behavioral therapy (CBT) is a novel treatment option with durable effects shown in primary insomnia. However, the lack of accessibility and expense can be limiting. For these reasons, computerized CBT for insomnia (CCBT-I) has been developed. The CCBT-I program is a 6-week web-based course consisting of daily “lessons” providing learnable skills and appropriate recommendations to help patients improve their sleep habits and patterns.MethodsWe conducted a single-center, pilot, randomized controlled trial comparing CCBT-I versus standardized sleep hygiene instructions to treat insomnia in PD. Twenty-eight subjects with PD experiencing insomnia, with a score > 11 on the Insomnia Severity Index (ISI) were recruited. Based on a 6-point improvement in ISI in treatment group when compared to controls and an alpha = 0.05 and beta of 0.1 (power = 90%) a sample size of 11 patients (on active treatment) were required to detect this treatment effect using a dependent sample t-test.ResultsIn total, 8/14 (57%) subjects randomized to CCBT-I versus 13/14 (93%) subjects randomized to standard education completed the study. Among completers, the improvement in ISI scores was greater with CCBT-I as compared to standard education (−7.9 vs −3.5; p = 0.03). However, in an intention-to-treat analysis, where all enrolled subjects were included, the change in ISI between groups was not significant (−.4.5 vs −3.3; p = 0.48), likely due to the high dropout rate in the CCBT-I group (43%).ConclusionThis pilot study suggests that CCBT-I can be an effective treatment option for PD patients with insomnia when the course is thoroughly completed. High drop-out rate in our study shows that although effective, it may not be a generalizable option; however, larger studies are needed for further evaluation.

Efficacy of cognitive behavioral therapy for insomnia comorbid to Parkinson's disease: A focus on psychological and daytime functioning with a single‐case design with multiple baselines

“…Most notably, we found that CBT‐i improved subjective insomnia severity at 3‐month follow‐up, with large treatment effects for the ISI (reduction of 12 points). These results are consistent with a recent trial documenting a significant 8‐point change of the ISI among patients with PD after having completed a computerized CBT‐i treatment (Patel et al, ). In the present study, we also used the SCI dedicated to evaluate insomnia based on DSM‐5 criteria with a well defined cut‐off value ≤16 for ID (Bayard et al, ; Espie et al, ).…”

“…In a retrospective case series of five patients, CBT‐i was evaluated through an average of eight‐sessions (range: 5–12; Humbert et al, ). Finally, a randomized controlled trial comparing computerized delivered CBT‐i versus standardized sleep hygiene instructions was conducted in 14 patients (Patel et al, ). Surprisingly, none of these studies comprised a clinical diagnostic interview for ID based on standardized criteria at the patient inclusion (American Academy of Sleep Medicine, ; American Psychiatric Association, ).…”

“…Furthermore, some cognitive deficits and psychological aspects of the disease, such as apathy may also represent a barrier to CBT-i application. Four studies evaluated the CBT-i efficacy in PD with various methodologies (Humbert, Findley, Hernandez-Con, & Chahine, 2017;Patel et al, 2017;Rios Romenets et al, 2013;Yang & Petrini, 2012). The first consisted in a single-group interrupted time series design conducted on 22 patients over 4 months (4 weeks telephone-based treatment time and 3 month follow-up) (Yang & Petrini, 2012).…”

“…Surprisingly, none of these studies comprised a clinical diagnostic interview for ID based on standardized criteria at the patient inclusion (American Academy of Sleep Medicine, 2014; American Psychiatric Association, 2013). In fact, patients were recruited based on their sleep complaint severity rated on insomnia severity index (ISI; Patel et al, 2017), Parkinsonʼs disease sleep scale (Yang & Petrini, 2012) or SCOPAsleep subscale (Rios Romenets et al, 2013). Humbert and coworkers did not provide any methodological information about this inclusion criterion (Humbert et al, 2017).…”

Practical Evaluation and Management of Insomnia in Parkinson's Disease: A Review

“…Individuals receiving CBT‐I/BLT experienced a significant reduction in ISI scores when compared with controls; however, conclusions about CBT‐I alone cannot be made because of the dual treatment tested. In a second study, Patel and colleagues examined the delivery of interactive, on‐line CBT‐I to a sleep hygiene education control. Individuals completing the CBT‐I intervention had a greater reduction in the ISI when compared with controls (−7.9 vs. −3.5; P = 0.03).…”