Non-specified depressive episode
Conditions
Interventions
This is a (participant) blind randomized, placebo-controlled, 5-arm clinical trial with 60 people in each group, whose allocation will be random. The 5 therapeutic groups will be: pharmacological excl
F02.463.551
MT3.795.992
G11.427.410.698.277
HP3.073.433.101
Sponsors
Universidade Federal do Rio Grande do Norte
Universidade Federal do Rio Grande do Norte
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Current depressive episode; Age between 18 and 40 years old; Study/ work in UFRN; Have internet connection to allow the usage of the app on the smartphone or computer website.
Exclusion criteria
Exclusion criteria: Diagnosis for mental illnesses other than major depressive disorder; Prescription of any medicine with psychiatric, neurological, neurovegetative, cognitive or mood effect other than antidepressants; Have any phobic symptom against injection, blood or wound; Pregnancy and lactation; Any physical or mental disability that make impossible the execution of the complementary therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an average reduction of 50% in depressive symptoms assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) between the 5th week and the beginning of treatment. In addition, it is expected that, at the end of treatment, the MADRS will be below 7 points on average (indicative of remission of the depressive condition). | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the response of depressive and anxiety symptoms reported by the participant, at baseline and at weeks 5 and 12, using Beck's depression (BDI-II) and anxiety (BAI) inventories, with an expected reduction of at least 50% in pre- and post-intervention (week 12) measurements.;Evaluate the response of mood and rumination profiles reported by the participant, weekly, using the questionnaires Profiles of Mood States - short version (POMS-VR) and Ruminative Response Scale - short version (RRS-VR). ;Assess the potential change in sleep quality and sleepiness indicators, using the Pittsburgh Sleep Quality Index (PSQI) and Karolinska Sleepiness Scale (ESK), respectively, at baseline, at the 5th week of treatment, and at the end of the study.;Assess dimensions of mindfulness, mind-wandering, and interoceptive sensibility, through the Five Facets of Mindfulness Questionnaire (FFMQ), Mind Excessively Wandering Scale (MEWS) and Multidimensional Assessment of Interoceptive Awareness (MAIA) scales, respectively, at baseline, in the 5th week of treatment, and at the end of the study. ;Based on previous studies comparing depressed individuals with healthy controls or variation after treatment with antidepressant drugs, a decrease in the levels of serum markers of stress (cortisol), inflammation (PCR, IL-6, TNF-alpha) and plasticity (BDNF) is expected, collected during treatment weeks 1 (baseline), 5 and 12 (end of treatment) and measured using the ELISA method, from finding a variation of at least 30%, 10%-20%, and 12%, respectively, after the end of treatment. ;Evaluate the affective and pleasure response on the execution of the mind-body practices, using the Affect Scale (EA) and the Physical Activity Enjoyment Scale (PACES), respectively, weekly, throughout the treatment.;Based on previous studies comparing depressed individuals with healthy controls or variation after treatment with antidepressant drugs, a decrease in the levels of biochemical markers is expected: fasti | — |
Countries
Brazil
Contacts
Public ContactNicole Galvão-Coelho
Universidade Federal do Rio Grande do Norte
Outcome results
None listed