How is your well-being?

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2019
INTERVENTION: Behavioural Mindfulness The intervention will be the Mindfulness‐Based Health Promotion (PSBM) program, structured and developed taking into account the Brazilian and Ibero‐American cultural context. The program will consist of eight sessions once a week lasting approximately one hour, always on the same day and time. The duration and frequency of the weekly sessions is based on the Mindfulness‐Based Stress Reduction program, a scientifically proven method developed by Jon Kabat‐Zinn in 1979. It indicates that the benefits of the practices are observed after two months of training. We will invite a qualified professional in mindfulness techniques, such as focus on breathing, body scanning and mindfulness walking. At the end of each practice, the volunteers will receive a form to report unwanted effects (Demarzo and Garcia‐Campayo, 2015, Cebolla et al., 2017). They will also be encoureged to adopt daily practices, that should be noted in the sleep log. The volunteers will be randomized in the passive control (PC), active control (AC) and intervention (MBI) groups. Whenever possible, we will adopt stratified randomization, in order to guarantee similarity between the groups, adopting chronotype, sleep quality, mental health status, age, gender, course and year of graduation as criteria for stratification. If it is not possible to perform this type of randomization, we will choose cluster randomization, and, in the latter case, simple randomization. The passive control group will not undergo any intervention and will only perform the collections, on the same days and times of the other two groups. The active control group will be used to avoid possible bias of changes originating from a welcoming sensation, rather than intervention per se (MacCoon et al., 2012). The activities of this group will include musical therapy, motor coordination, posture, balance, among others, during the eight weeks, at the same time and with the same duration as the MBI group. The MBI group will go through the CONDITION: Circadian Rhythm F00‐F99 Mental Health Assistance Mental Health Assistance; Circadian Rhythm ; Mental Health Assistance ; Circadian Rhythm PRIMARY OUTCOME: Increase of melatonin secretion assessed by urinary secretion Phase adjustment of circadian rhythms assessed by the actigraph Phase adjustment of clock genes assessed by the Real Time PCR SECONDARY OUTCOME: Improvement in self‐compassion global scores above 2.5 assessed by Self‐Compassion Scale Reduction in overall mental health below 8 assessed by the Hospital Anxiety and Depression Scale Reduction in overall sleep quality scores below 5 assessed by Pittsburgh Sleep Quality Index ; ; ; subjective stress reduction (Stress Perception Scale) and cortisol levels, improvement of self‐pity above 2.5 in the Self‐pity Questionnaire and percentage of quality of life. Reduction of negative affects and increase of positives. Reduction in salivary cortisol levels Reduction in subjective stress assessed by the Stress Perception Scale INCLUSION CRITERIA: STUDY 1; graduate students of the Universidade Federal de Sao Paulo; age over 18; all genders. STUDY 2; complete answers to the Study 1 questionnaires within one month of their submission; acceptance to participate in the second stage.
Epistemonikos ID: 1cb93276a6adebaf9f5afb14ceecf266a14dda42
First added on: Aug 24, 2024