A comparative study on the efficacy of an educational and behavioural intervention for the withdrawal of long-term hypnotics: a randomized controlled clinical trial

Abstract

Background: Long-term use of hypnotics, for the treatment of chronic insomnia, has increased in the last decades. This fact constitutes a health problem due to a chronic use of hypnotics do not present a favourable risk-benefits relation. First, there is no evidence of them being beneficial when the treatment lasts more than 4 weeks. And second, the use of a hypnotic, as almost all pharmacological treatment, implies a risk of side effects (such as daily somnolence, tolerance, dependence and increased risk of dementia, falling and bone fractures) that increases as long is the treatment. Objective: To compare the efficacy of an educational and behavioural group intervention in contrast to a written educative intervention, at primary care, on the withdrawal of long-term hypnotics. Design: A multicentre, randomized, parallel group, comparator-controlled clinical trial conducted in the 4 basic health areas of Girona. Participants: Adults between 18 and 85 years old, living in Girona, under a daily treatment with hypnotics during a period of 6 or more weeks. A total of 100 patients will be recruited from each basic health area using a simple random sampling. Intervention: First, participants will receive an educational and behavioural intervention or a written educative intervention, which will be randomly allocated by basic health areas. Then, all participants will be subjects of an evaluation of their stage on the Prochaska and DiClemente model, in order to decide whether a gradual tapering plan of hypnotics is offered to them