Assessing the feasibility and acceptability of a cluster-randomized study of cognitive behavioral therapy for chronic insomnia in a primary care setting.

BACKGROUND: Cognitive behavioral therapy for chronic insomnia (CBT-i) is the treatment of choice for this condition but is underutilized in patients who attend primary care. The purpose of the present feasibility-pilot study was to assess the feasibility and acceptability of a cluster-randomized study of CBT-i in a primary care setting. METHODS: This study, performed at two primary health care centers in Majorca, Spain, was a mixed methods feasibility-pilot study of a parallel cluster-randomized design comparing CBT-i and usual care (UC). Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ≥ 8); had insomnia for more than 3 months. Twenty-five GPs and nurses and 32 patients were randomly allocated to two groups. The main outcome of the intervention was improvement of dimensions of sleep quality, measured using the Spanish version of the Pittsburgh Sleep Quality Index, at baseline and at 3 months after the intervention. Other primary outcomes of the study were the feasibility and applicability of the intervention, collected through nominal groups. A thematic analysis was performed to classify primary care provider (PCP) proposals. Additionally, we assessed the recruitment process, compliance with the intervention sessions, and patient retention. RESULTS: We adapted the CBT-i approach of Morin to a primary care context. After intervention training, PCPs expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer but longer sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, higher proportions of patients in the intervention group had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions. CONCLUSIONS: This feasibility-pilot study identified several key issues that must be addressed before performing a CBT-i intervention in future clinical trial in a primary care setting. TRIAL REGISTRATION: NCT04565223 . (Clinical trials.gov) Registered 1 September 2020-Retrospectively registered.

[Prevalence of insomnia and characteristic of patients with insomnia in a health area of Majorca (Spain)]. / Prevalencia de insomnio y características de la población insomne de una zona básica de salud de Mallorca (España).

OBJECTIVES: To estimate insomnia prevalence as well as habits comorbidity, sleep quality of insomnia patients. DESIGN: Cross sectional descriptive study. SETTING: Calvia health center (Majorca, Spain). PARTICIPANTS: We included subjects registered in a Health Center (> 2 years) of 18-80 years old. METHODS: Firstly, they were interviewed by telephone in order to identify persons with insomnia using the Insomnia Severity Index. Afterward, subjects with insomnia were interviewed in the health center in order to collect the data. RESULTS: From a simple of 1,563 persons, we contacted 591 and 467 participated. Insomnia prevalence was 21.1% (IC 95% 17.38-25.01) and 6.9% (IC 95% 4.45-9.25) clinical insomnia. It was significantly more frequent in women, widow, divorced, retired and unemployed. Two in three presented obesity or overweight, 37% chronic pain, 21.1% depression and 37.9% anxiety. Half of the patients with insomnia referred a negative impact on daily activities and difficulties to maintain enthusiasm. Moreover, 41.1% declared to take pharmacological treatment for sleep usually. The more common therapeutic measures for insomnia were sleep hygiene and benzodiazepines; while cognitive-behavioral therapies were rarely used. CONCLUSIONS: The prevalence of insomnia in our health area is similar to those described in population based studies. The presence of some prejudicial habits for sleep quality as well as comorbidities could facilitate insomnia to become a chronic illness. Then, management of insomnia should be considered in a patient more general context. Pharmacological treatment is still in the first line and effective non pharmacological treatment is still a rare option.

Knowledge and attitudes of primary care nurses about the management of patients with insomnia. / Conocimientos y actitudes de las enfermeras de Atención Primaria sobre el manejo del paciente con insomnio.

OBJECTIVE: To describe the knowledge, attitudes, and performance of primary care nurses in the management of patients with insomnia. METHODS: Descriptive study. An online questionnaire was sent to all primary care nurses of the Majorca Primary Care Department between June-July 2014. MEASUREMENTS: sociodemographic variables, professional characteristics, tuition, usual clinical practice in the management of patients with insomnia. RESULTS: 138 nurses answered the questionnaire (47%). Most of them were women (92.8%), 50.42 years old (DE=8.9). The majority considered insomnia an important health problem. Only 11% had received some formative activity on insomnia in the last 5 years. Nearly half declares to ask patients about consequences of insomnia in their jobs and about habits that alter their sleep quality. 79.7% considered the possible adverse effects of insomnia drugs and take into consideration the age of patient (80.4%). The usual treatments were sleep hygiene (76%), phytotherapy (44.9%) and 22.4% cognitive behavioral therapy (CBT). This therapy is considered effective and applicable by nurses (63.7%) and doctors (58%). Those nurses who attended courses in the last 5 years apply CBT more frequently. CONCLUSIONS: Nurses conduct a correct anamnesis and evaluation of patients with insomnia. However some therapies of known effectiveness, such as CBT, are still scarcely applied.

[Attitudes to insomnia by Primary Care physicians of Majorca (Spain)]. / Actitudes ante el insomnio de los médicos de AP de Mallorca.

OBJECTIVES: To describe the current clinical management of insomnia by family physicians. DESIGN: Cross-sectional study. SETTING: Majorca Health Area, 2011-2012. PARTICIPANTS: Family physicians (FP). Paediatricians, resident physicians and emergency physicians were excluded. MEASUREMENTS: Using a self-administered questionnaire, the following variables were collected: social, demographic, professional, training in insomnia, prescription preferences, and its clinical management. RESULTS: A total of 322 of 435 physicians answered (74%), of whom 55% were female. The mean age was 48 years with a mean of 21 years in the profession. Most of them consider insomnia as a major health problem, and refer to asking patients about sleep habits and its impact on daily life. About one third have been trained in insomnia in the last 5 years. Very few (0.6%) refers patients to a psychiatrist, and 1.9% to a psychologist. The most prescribed drugs are benzodiazepines (33.4%) and Z drugs (25.7%), with 69.4% of them claiming to have checked the treatment after month of onset. Most refer to advice about sleep hygiene measures (85.1%), 15.1% prescribe herbal remedies, and 14.2% behavioural cognitive therapy (CBT). Seven out of ten physicians consider CBT as effective and applicable by both physicians and nurses. The older FPs prescribe benzodiazepines with less frequency, while female FPs prescribe more sleep hygiene measures and herbal remedies. CONCLUSIONS: Most FPs consider insomnia as a major health problem, in which they usually get involved. The most commonly used treatments are sleep hygiene advice, followed by benzodiazepines and Z drugs. The CBT is considered effective but not widely used.