Mental Health Assistance
Conditions
Interventions
This is a two-arm randomized controlled trial, with blinding for the statistical analyses only. Experimental group: 30 university students with poor subjective sleep quality will receive the Mindfulne
F02.463.551
Sponsors
Departamento de Psicobiologia da Universidade Federal de São Paulo
Centro Universitário São Camilo
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Students of all genders; aged between 18 and 60 years; enrolled in at least one of the undergraduate courses in the health area at the Federal University of São Paulo or at the São Camilo University Center; with poor subjective sleep quality (score higher than 5 on the Pittsburgh Sleep Quality Index)
Exclusion criteria
Exclusion criteria: Pregnant and lactating women within six months; previous or current use of melatonin analogues; current or previous use of drugs from the class of beta blockers and inhibitors (selective or not) of serotonin receptor (interfere with the biosynthesis of melatonin); previous diagnosis of mental disorders (anxiety, depression, schizophrenia, bipolar disorder); regular practice (twice a week or more) of mindfulness, meditation, yoga, and the like in the past six months; diagnosis of sleep disorders (e.g. obstructive sleep apnea and insomnia) or previous participation in a study with a related topic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to observe a 33% reduction in the score for subjective sleep quality, as assessed by the Pittsburgh Sleep Quality Index.;Outcome found 1: A 17% reduction in subjective sleep quality scores, as measured by the Pittsburgh Sleep Quality Index, was observed in the control group, compared to a 35% reduction in the intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It is expected to observe a 33% decrease in the score for sleep hygiene, as assessed by the Sleep Hygiene Index.;Expected outcome 3: It is expected to observe a 33% reduction in the score for daytime sleepiness, as assessed by the Epworth Sleepiness Scale.;Expected outcome 4: It is expected to observe a 33% in phase advance in the score for chronotype, as assessed by the Munich Chronotype Questionnaire.;Expected outcome 5: It is expected to observe a 33% increase in the score for well-being, as assessed by the WHO5 - Subjective Well-being Index.;Expected outcome 6: It is expected to observe a 33% reduction in the score for burnout, as assessed by the Copenhagen Burnout Inventory - Student Version.;Expected outcome 7: It is expected to observe a 33% reduction in the score for depression and anxiety, as assessed by the Hospital Anxiety and Depression Scale.;Expected outcome 8: It is expected to observe a 33% reduction in the score for perceived stress, as assessed by the Perceived Stress Scale.;Expected outcome 9: It is expected to observe a 33% increase in the score for mindfulness, as assessed by the Philadelphia Mindfulness Scale.;Expected outcome 10: A 33% reduction in the time awake after sleep onset, as assessed by actigraphy, is expected.;Expected outcome 11: A 33% increase in the total sleep time, as assessed by actigraphy, is expected.;Expected outcome 12: It is expected to observe a 33% in phase advance in the 6-sulfatoxymelatonin and cortisol, as assessed by the biochemical analisys.;Outcome found 2: A 3% reduction in sleep hygiene scores, as measured by the Sleep Hygiene Index, was observed in the control group, compared to a 11% reduction in the intervention group.;Outcome found 3: A 5% increase in daytime sleepiness scores, as measured by the Epworth Sleepiness Scale, was observed in the control group, compared to a 15% reduction in the intervention group.;Outcome found 4: A 1% phase delay in the score for chronotype, as measured by t | — |
Countries
Brazil
Contacts
Public ContactJulia Vallim
Universidade Federal de Sao Paulo
Outcome results
None listed