Effect of a Counseling Program on Depression symptoms and physical activity, sedentary behavior, and sleep in adults with depressive symptoms

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: F01.145.632 F01.145.749 F02.830.855 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, for 1.5 hours, over 16 weeks. There will be lectures, distribution of teaching materials, group discussions, actions and practical classes. The main themes will be related to 24‐hour movement behaviors and depressive symptoms. Control group: 28 people will continue their usual activities, without any intervention by the research team. CONDITION: Depressive Disorder, Major F03.600.300 PRIMARY OUTCOME: 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" (9 to 14 points) and "moderate to severe" (= 15 points). SECONDARY OUTCOME: Physical activity. Instruments: accelerometry; short version of the International Physical Activity Questionnaire (IPAQ); instruments/questions used in the Vigitel survey. This outcome will be collected in the baseline, post‐intervention (16 weeks) and si Xmonths after the end of the intervention (follow‐up). Variable interpretation: continuous (= 100 counts) and categorized based on intensity (mild, moderate and vigorous) and domain (commuting, domestic, leisure, work). Sedentary behavior. Instruments: accelerometry; short version of the International Physical Activity Questionnaire (IPAQ); instruments/questions used in the Vigitel survey. This outcome will be collected in the baseline, post‐intervention (16 weeks) and si Xmonths after the end of the intervention (follow‐up). Variable interpretation: continuous (< 100 counts) and categorized based on the cut‐off point of = 8 hours/day and the type of indicator (“Mentally passive” and “Mentally active”). Sleep. Instruments: accelerometry; Pittsburgh Sleep Quality Index. This outcome will be collected pre‐intervention, post‐intervention (16 weeks) and si Xmonths after the end of the intervention (follow‐up). Variable interpretation: continuous (< 100 counts) and categorized into "good quality" (= 5 points) and "poor quality" (= 6 points). 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
Epistemonikos ID: f865e0d7d4d09dcc3531a30d5f02ebc7f75feaad
First added on: Feb 20, 2024