Depressive Disorder, Major
Conditions
Interventions
This is a two-arm randomized controlled clinical trial with blinded evaluators. Total of participants: 56. Intervention group: 28 people will participate in a counseling intervention, twice a week, fo
F01.145.632
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
20 Years to 59 Years
Inclusion criteria
Inclusion criteria: Be a volunteer; score = 9 points on the Patient Health Questionnaire-9 (PHQ-9); be aged between 20 and 59 years; have an electronic device with a camera and microphone installed, such as a computer, tablet or cell phone; have access to the internet; have availability for days and times of online and face-to-face meetings
Exclusion criteria
Exclusion criteria: Present a need for specialized psychiatric treatment, ignoring cases of depression (eg, psychosis, schizophrenia); present suicidal risk (scoring 2/3 in the PHQ-9 suicidal risk question); present change in antidepressant medication in the month prior to recruitment or during the intervention; having diseases or physical limitations that prevent participation in the study; being pregnant or being in the puerperium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms assessed by the Patient Health Questionnaire-9, considering a total score =9 points as the cut-off point. This outcome will be collected in the baseline, post-intervention (16 weeks) and six months after the end of the intervention (follow-up). Variable interpretation: continuous and categorized as "mild" (= 8 points), "moderate" (9 to 14 points) and "severe"(= 15 points). | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep. Instruments: accelerometry; Pittsburgh Sleep Quality Index, and Simple Physical Activity Questionnaire (SIMPAQ). This outcome will be collected pre-intervention, post-intervention (16 weeks) and six months after the end of the intervention (follow-up). Variable interpretation: continuous in minutes/week and hours/day, and categorized into "good quality" (= 5 points) and "poor quality" (= 6 points).;Physical activity. Instruments: accelerometry; short version of the International Physical Activity Questionnaire (IPAQ); Simple Physical Activity Questionnaire (SIMPAQ); instruments/questions used in the Vigitel survey. This outcome will be collected in the baseline, post-intervention (16 weeks) and six months after the end of the intervention (follow-up). Variable interpretation: Continuous in minutes/day (total, light and moderate to vigorous); continuous in minutes/week (walking, exercise and other activities), continuous in minutes/week (commuting, domestic, leisure and work).;Sedentary behavior. Instruments: accelerometry; short version of the International Physical Activity Questionnaire (IPAQ); Simple Physical Activity Questionnaire (SIMPAQ); instruments/questions used in the Vigitel survey. Questionnaire by Mielke et al. (2020), to evaluate the time spent in sedentary behaviors during a usual day of the week and on Sundays in different contexts, such as: a) watching television; b) using the computer at home; c) using a cell phone; d) sitting at work; e) sitting at school/university; f) sitting while traveling by car, motorbike or bus. This outcome will be collected in the baseline, post-intervention (16 weeks) and six months after the end of the intervention (follow-up). Variable interpretation: Continuous in minutes/week and hours/day, and categorized based on the cut-off point of = 8 hours/day and the type of indicator (“Mentally passive” and “Mentally active”). | — |
Countries
Brazil
Contacts
Public ContactGiovani Del Duca
Universidade Federal de Santa Catarina
Outcome results
None listed