Project Details
Projekt
Investigating non-inferiority and additional benefits of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial
Applicant
Professor Dr. Kai Spiegelhalder
Subject Area
Personality Psychology, Clinical and Medical Psychology, Methodology
Clinical Psychiatry, Psychotherapy, Child and Adolescent Psychiatry
Clinical Psychiatry, Psychotherapy, Child and Adolescent Psychiatry
Term
since 2021
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 422022593
Difficulties in initiating and/or maintaining sleep in combination with a high degree of suffering or impaired daily activities are the main characteristics of insomnia. The worldwide prevalence of insomnia is around 6-10%. Insomnia is a heavy burden for patients as it impairs their social, family, and occupational life, and has a highly negative impact on quality of life. In terms of disability-adjusted life years, insomnia is the 9th most important brain disorder. Moreover, insomnia is also a major risk factor for depression and anxiety disorders as well as for cardiovascular diseases and diabetes. Finally, insomnia represents a heavy socioeconomic burden, especially due to productivity losses. The two most commonly used treatments for insomnia are benzodiazepine receptor agonists (BZRA) and cognitive-behavioural therapy for insomnia (CBT-I). BZRA improve sleep continuity in short-term treatment, but tolerance and dependence are important side effects. CBT-I, by contrast, is safe and effective with large effect sizes on insomnia severity. Clinical guidelines unanimously recommend CBT-I as the first-line treatment. However, health insurance data suggests that CBT-I is not widely available in routine care and mainly offered in a few specialised research settings. As a result, patients with insomnia have limited access to first-line treatment in clinical practice. Recently, there has been growing evidence that internet-delivered CBT-I (iCBT-I) is highly effective with effects appearing to be comparable to those of face-to-face CBT-I. Consequently, iCBT-I has been suggested as a promising solution since it can be disseminated on a large scale, giving more patients access to effective treatment. In addition, it is easily accessible anytime and anywhere, fitting in with an increasingly digital lifestyle. The higher flexibility of iCBT-I may provide more convenience, patients save some of the time and costs of seeing therapists. Although there are good reasons to hypothesize that iCBT-I is an adequate alternative to face-to-face CBT-I, conclusive evidence has not yet been established. In fact, it has not been proven whether the optimism about iCBT-I as an additional first-line treatment is justified. For the first time, the planned non-inferiority study will investigate whether patients would benefit from iCBT-I to the same degree as from face-to-face interventions. So far, iCBT-I and face-to-face CBT-I have not yet been evaluated in an adequately designed non-inferiority study. In case non-inferiority is confirmed, patients can be confident that both formats of CBT-I are equally likely to reduce insomnia severity. Similarly, the study will provide solid evidence for general and sleep medicine practitioners and psychotherapists, broadening their therapeutic options. Policy-makers will gain information useful for implementing iCBT-I into routine care.
DFG Programme
Clinical Trials
