Adding digital cognitive-behavioral therapy (dCBT) to treatment as usual for insomnia disorder, compared with sleep hygiene education alone, can significantly improve multiple daytime effects from poor sleep, including moodiness and lower cognitive functioning, new research suggests.
In a randomized clinical trial, the large improvement in insomnia associated with dCBT mediated small improvements in functional health and psychological well-being, as well as large improvements in sleep-related quality of life. Significant improvements in these factors occurred at 4, 8, and 24 weeks following initiation of dCBT.
“Insomnia is the most common expression of mental ill health in the world. It presents mostly in primary care, but also in association with disorders such as depression and psychosis,” principal investigator Colin A. Espie, PhD, Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom, told.
“For decades it has been a disorder in search of a solution. Sleeping pills are less effective for chronic sleep problems than CBT, the treatment recommended by the American College of Physicians [ACP],” Espie added.
“However, CBT has not been available at the necessary scale. The advent of dCBT represents a potential solution,” he said.
The findings were published online September 25 in JAMA Psychiatry.
Shining Daylight on Symptoms
The 2016 ACP guidelines recommend CBT as first-line treatment for adults with insomnia — before prescription sleep medications. The guideline authors note there are multiple effective ways to deliver CBT, including online methods using websites or mobile devices.
CBT takes a three-pronged approach to treating insomnia. A behavioral component addresses stimulus control, sleep restriction, and relaxation; a cognitive component focuses on managing sleep-related worries, a racing mind, or intrusive thoughts; and an educational component addresses sleep hygiene.
Evidence continues to emerge that dCBT can improve not just sleep but also aspects of overall health that sleep mediates, including stress, anxiety, depression, and other mental health conditions, the authors note.
The current study builds on a prior review from Espie and colleagues that concluded the clinical evidence for dCBT “has substantially increased over the last few years, from which it seems reasonable to conclude that dCBT is effective even in comorbid conditions, and that there are likely benefits beyond sleep to mental health and well-being.”
Systematic reviews/meta-analyses have also supported use of dCBT for insomnia.
Despite the evidence so far, “an adequately powered, definitive trial investigating functional health status, psychological well-being, and a patient-generated assessment of quality of life has not yet been conducted,” the current investigators write.
Online Therapy vs Sleep Hygiene
For the Digital Insomnia Therapy to Assist Your Life as Well as Your Sleep (DIALS) study, the researchers enrolled 1718 adults who screened positive for insomnia disorder using DSM-5 criteria and the eight-item Sleep Condition Indicator. They recruited participants between December 2015 and December 2016.
Of the total participants, 853 were randomly assigned to receive dCBT and 858 to a control group that received sleep hygiene education (SHE).
SHE advice included recommendations about bedtime routines and intake of alcohol and caffeine. SHE reflects what patients with insomnia are most typically offered in routine care, the researchers note. All participants could continue any treatment as usual.
Most participants were women (78%), the mean age was 48 years, and most were white (91%). Fewer than 1% identified as Asian, black, or of mixed race or another race/ethnicity. The remainder did not wish to state their race or ethnicity.
A fully automated program and associated iOS app (Sleepio, Big Health Ltd) was used to deliver dCBT. Participants accessed six 20-minute sessions during a 12-week period.
The investigators assessed participants at baseline and at 4, 8, and 24 weeks. At week 25 of the study, all control group participants were offered dCBT.
Primary outcome measures included the Patient-Reported Outcomes Measurement Information System Global Health scale for physical health, the Warwick-Edinburgh Mental Wellbeing Scale for psychological well-being, and the Glasgow Sleep Impact Index.
The dCBT intervention was associated with significant improvements in global health at weeks 4, 8, and 24. The Cohen d standardized effect size was 0.16 at week 4, 0.31 at week 8, and 0.31 at week 24.
dCBT was also associated with a significant improvement in mental well-being, with Cohen d values of 0.13, 0.35, and 0.38 at weeks 4, 8, and 24, respectively.
Likewise, significant reductions were shown in sleep-related impairment to quality of life, with a -0.69 Cohen d for week 4, -1.38 for week 8, and -1.46 for week 24.
Secondary Outcomes
The researches also assessed six typical daytime effects of insomnia disorder, including mood, energy, cognitive functioning, sleepiness, relationship satisfaction, and work performance/satisfaction.
Improvements in symptoms of depression measured on the Patient Health Questionnaire–9, of anxiety on the Generalized Anxiety Scale, of sleepiness on the Epworth Sleepiness Scale, and of cognitive problems on the Cognitive Failures Questionnaire all showed significant differences in favor of dCBT at weeks 4, 8, and 24 — although the effect sizes were small.
In contrast, the investigators report moderate to large effects at weeks 4, 8, and 24 for fatigue on the Flinders Fatigue Scale.
On the Work Productivity and Activity Impairment questionnaire, productivity at work (presenteeism) attributed to sleep problems showed a small to moderate improvement after dCBT relative to the control group. Specifically, there was a significant but small effect in reduced absenteeism attributed to poor sleep and increased job satisfaction at week 24.
There were no significant effects at any time point on relationship functioning, as measured on the Relationship Assessment Scale.
Using dCBT does not replace face-to-face psychiatric treatment, but rather supports it, Espie said. “It gives people suffering from insomnia access to clinically proven techniques that can help them modify their behavior and get better sleep.
“In this study, we found that dCBT could also improve functional health and sleep-related quality of life. These findings underline the tremendous importance of sleep to general health,” he added.
Currently, an estimated 10% to 12% of the population do not get enough sleep because of insomnia. “The results suggest that dCBT could improve the general well-being of millions of people who suffer from lack of sleep, he said.
A potential limitation of the study was treatment drop-off over time in the dCBT group. Although 81% logged on for at least one dCBT session, only 58% completed at least four sessions, and 49% completed all six dCBT sessions. In contrast, 89% of the SHE cohort accessed their online education.
“Digital CBT is a promising approach for a wide range of mental health conditions. In the future, we’ll be exploring its effects on depression and anxiety as well,” Espie said.
“Significant Impact”
Lee Ritterband, PhD, professor of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine in Charlottesville, said the study is “a nice addition to the growing literature on ehealth generally, and Internet interventions for insomnia specifically.
“It is further evidence that fully automated Web and mobile programs can have significant impact on the lives of many,” said Ritterband, who was not involved with the study.
“Digital therapeutics are increasingly being accepted as a viable option to deliver certain health services, due to the rigorous research being conducted on the best of these programs,” he added.
“As these technology-based interventions become more common, I would encourage users, including patients and doctors, to ensure there is strong research data supporting the programs they use or recommend as beneficial,” he said.
Also Aric A. Prather, PhD, associate professor in the Department of Psychiatry at Weill Institute for Neurosciences, University of California, San Francisco, said, “it is now clear” that this type of CBT for insomnia (CBT-I) is effective in reducing symptoms of the sleep disorder.
He added that the current study contributes to the digital CBT-I literature by demonstrating that global measures of physical and mental health are associated with improvements in sleep and feelings of overall well-being.
“This is an important next step in demonstrating that sleep is a critical contributor to our daily experience and that improvements in our sleep can have fairly substantial spillover to how we live our best lives,” he said.
Prather, who was not involved with the research, noted that, as the authors point out, the study population was not taken from a clinical setting. This approach increases the generalizability in addressing insomnia in a general population, “but on the other hand may not reflect the effects one might see in patients seen in a clinic,” he added.
“That said, the findings appear to be strong and maintained or even strengthened 4 months after treatment, suggesting that treating insomnia complaints with digital CBT-I is far superior to traditional sleep hygiene for affecting many important life domains,” Prather said.
“Clinicians who see patients who meet criteria for insomnia should strongly consider digital CBT-I as a treatment strategy, particularly in areas where trained CBT-I clinicians are unavailable.”
The study was funded by Big Health Ltd and the National Institute for Health Research (NIHR), Oxford Biomedical Research Center, NIHR Oxford, the Health Biomedical Research Center, the NIHR Biomedical Research Center at South London, the Maudsley National Health Service Foundation Trust, King’s College London, and the Dr Mortimer and Theresa Sackler Foundation. Dr Espie receives a salary from Big Health Ltd and is a cofounder, chief medical officer, and shareholder in the company; he is also a developer of Sleepio. Dr Ritterband and Dr Prather have reported no relevant financial relationships.
JAMA Psychiatry. Published online September 25, 2018.
