A combination of cognitive behavioral therapy and medication had the most profound and stable result for patients suffering from insomnia.
Digital cognitive behavioral therapy for insomnia (dCBT-I) with medication could be the optimal treatment of insomnia disorder, according to a study recently published in JAMA. This is the first study that takes a systematic look at dCBT-I from multiple perspectives using clinical data.
“dCBT-I is effective and has long-term benefits in patients with insomnia and that the combination of medication and dCBT-I is associated with sustained improvement in sleep quality compared with medication monotherapy,” the study authors wrote.
Insomnia disorder is characterized by 3 or more nights of poor sleep per week for 3 or more months, resulting in adverse daytime effects and reduced human functions, such as immunity. Suggested to affect nearly 20% of adults worldwide, insomnia decreases quality of life and has various pathogenic effects.
dCBT-I delivers the various therapeutic components of cognitive behavioral therapy for insomnia (CBT-I)—stimulus control, sleep restriction, relaxation training, cognitive reconstruction, and sleep hygiene—to patients via a lower-cost app. The National Institute for Health and Care Excellence of the United States and England recommends CBT-I as a tool to reduce dependence on zolpidem, zopiclone, and other sleeping pills.
The current literature consists of randomized clinical trials (RCTs) that compare the efficacy of dCBT-I, face-to-face CBT-I, and usual care. However, RCTs are not generalizable because they do not reflect the therapy’s efficacy in normally complex clinical scenarios that are influenced by external factors.
In this retrospective study, investigators evaluated the clinical efficacy, engagement, durability, and adaptability of dCBT-I, medication therapy, and the combination to treat insomnia. Investigators collected data using the Good Sleep 365 mobile app, which offers CBT-I training, medication records, and sleep quality assessment over a 6-month period.
The study included 4052 patients in the Chinese population who either received dCBT-I (n=418), medication (n=862), or combination therapy (n=2772). The primary outcome was the score on the Pittsburgh Sleep Quality Index (PSQI), which evaluates the efficacy of dCBT-I, medication therapy, or combination therapy. Secondary outcomes were treatment efficacy on comorbid somnolence, anxiety, depression, and somatic symptoms.
dCBT-I and combination therapy significantly reduced incidence of insomnia in 6 months. While both were comparably effective, dCBT-I was less durable in having sustained improvement compared to combination therapy. Both reduced secondary outcomes as well.
In addition, dCBT-I and combination therapy were proven to be more advantageous for all subgroup populations than medication alone. Patients on medication therapy prior to dCBT-I had more noticeable improvements after the interventions, and male patients also showed more benefits from dCBT-I.
The researchers noted several limitations to the study. Retrospective studies are not the most standardized study design, the study could have biases because participants and therapists were unblinded, the cohort contained few study samples, and retrospective studies do not provide enough reliable evidence, thus investigators should conduct more inclusive randomized control trials.
“Our main findings about effectiveness are consistent with previous findings that CBT-I can achieve better sleep health outcomes compared with medication therapy, combinations of CBT-I and medications had the potential to optimize outcomes,” the study authors wrote.
Lu M, Zhang Y, Zhang J, et al. Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. JAMA Netw Open. 2023. doi:10.1001/jamanetworkopen.2023.7597