A new study shows a digital therapeutic for insomnia works, but with important caveats.
The use of digital cognitive behavioral therapy for insomnia (dCBT-I) offers meaningful clinical benefits, according to a new report, but the optimal treatment strategy is to pair it with medication therapy.
The authors of the new study, which was published in JAMA Network Open, said combining dCBT-I with medication led to longer-term benefits for people with insomnia.
Insomnia is estimated to affect between 10% and 20% of adults globally, and the number of people experiencing symptoms of insomnia continues to rise, wrote corresponding author Hongjing Mao, M.D., of the Hangzhou Seventh People’s Hospital, in China, and colleagues.
While medications are available to help treat the condition, one of the most prominent drug-free therapeutic strategies is cognitive behavioral therapy for insomnia (CBT-I), which helps train patients in skills such as relaxation, sleep hygiene, and stimulus control. As with other types of CBT, investigators have been exploring the benefits of CBT-I when delivered in the form of a digital therapeutic (dCBT-I), such as through a smartphone application.
“As a low-cost complement to CBT-I, dCBT-I has demonstrated efficacy in randomized clinical trials (RCTs) and meta-analyses for decreasing insomnia severity, enhancing sleep quality, reducing sleep medication intake, and mitigating comorbid mental disorders,” Mao and colleagues said.
However, the authors said most of the existing studies amount to trials comparing in-person CBT-I to dCBT-I or comparing in-person CBT-I to medication monotherapy or combination therapy.
In the new study, the investigators took a different approach. They retrospectively pulled data from more than 3 years of real-world users of a mobile application that delivered CBT-I. They divided patients based on whether they used dCBT-I, medication, or both, and then compared the results at 1, 3, and 6 months.
A total of 4,052 users, three-quarters of whom were female, were included in the study. Most of those patients (2,772 participants) used a combination of dCBT-I and medication. Another 862 used medication only. The remaining 418 patients used dCBT-I only.
Using the Pittsburgh Sleep Quality Index (PSQI) assessment, the investigators found that patients using dCBT-I alone had a greater improvement in sleep than those using medication therapy alone. However, the benefits of dCBT-I alone were unstable. During the first three months, patients experienced rapid and steady improvement in their sleep, Mao and colleagues found. Yet, in the remaining months of the study those benefits became less durable. Those using medication therapy alone saw their outcomes level off after just one month, and outcomes continued to worsen by the fourth and fifth month. But when dCBT-I and medication therapy were paired, the benefit was more durable benefit for patients, they said.
The study is important because of the number of prescription digital therapeutics that techniques and tactics based CBT. The study offers real-world indications of where digital CBT might fit into treatment strategies.
While the overall study showed dCBT-I can be a meaningful part of insomnia therapy, it also came with a caveat. The authors found just 36.58% of dCBT-I participants participated in all of the CBT-I sessions. Better than 90% completed the relaxation training and sleep restriction sessions, but rates were significantly lower for the other sessions.
Overall, Mao and colleagues said their findings support the use of dCBT-I, but they said more research is needed to more fully understand its place in insomnia treatment.
“Given the unstable durability of dCBT-I at 6-month follow-up, the design, implementation, and delivery of dCBT-I in the practice setting warrants further investigation,” they concluded.