Sedentary Behavior and Depressive Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical activity intervention, Standard of care.
- Who it may be relevant to
- Registry conditions: Depression, Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sedentary Behavior and Depressive Symptoms: Influence of Specific Domains of Sedentary Behavior
Overview
Depressive symptoms are commonly observed in the general population. Individuals with subclinical forms of depression (e.g., not meet the criteria to major depression disorder) are at increased risk of mortality than the general population which is partially explained by the higher incidence of cardiovascular diseases. Currently, the effectiveness of the frontline treatment for depression is not consensual. Further, it also may be expensive for individuals with mild to moderate depression. Sedentary behavior is an independent risk factor for cardiometabolic diseases and mental disorders. However, recent evidence suggests that not all types of sedentary behavior are equally detrimental. For instance, mentally passive sedentary behavior (e.g., watching TV) appear to be detrimental for health outcomes whereas mentally active sedentary behavior (e.g., desk-based office work) appear to offer health benefits. However, more studies are required to determine the magnitude of association between distinct types of sedentary behaviors (e.g., watching TV, listening to music, talking while sitting, sitting around and doing nothing special) with depressive symptoms as well as randomized clinical trials investigating potential benefits of interventions to replace mentally-passive sedentary behaviors with mentally active sedentary behaviors, light physical activity or moderate-to-vigorous activity in individuals with mild to moderate depression. Therefore, the aim of this proposal is to investigate the influence of mentally passive sedentary behavior (i.e., watching TV, listening to music, talking while sitting, sitting around, and doing nothing special) on depressive symptoms. This is a randomized clinical trial. Participants with mild to severe depressive symptoms will be randomly assigned (1:1) into either INTERVENTION or CONTROL group, using a computer-generated randomization code. Depressive symptoms, quality of life, physical activity, sedentary behavior, body composition, and functionality will be assessed at baseline (PRE) and 4 (POST) months after the experimental period. The INTERVENTION group will participate in a 4-month goal-setting intervention aimed to replace mentally passive sedentary behaviors with mentally active sedentary behaviors, light physical activity, or moderate-to-vigorous activity while CONTROL group will receive general instructions related to WHO guidelines for physical activity.
Interventions
- Behavioral Physical activity intervention
The INTERVENTION group will participate in a 4-month goal-setting intervention aimed to replace mentally passive sedentary behaviors with mentally active sedentary behaviors, light physical activity, or moderate-to-vigorous activity. - Behavioral Standard of care
The CONTROL group also will participate of 4 face-to-face individual sessions during the experimental period, lasting \~15-30 minutes, however they will receive general instructions related to WHO guidelines for physical activity
Primary outcome measures
- Depressive Symptoms [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
Secondary outcome measures (11)
- Anxiety Symptoms (primary outcome) [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Indirect physical activity levels assessment [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Objective physical activity levels assessment [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Indirect sedentary behavior assessment [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Objective sedentary behavior assessment [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Quality of life assessement [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Body Weight [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Fat mass (kg) [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Fat-free mass (kg) [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Muscle Function (30-s Sit-to-stand Test) [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
- Muscle Function (Timed-up-and-go) [Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)]
Eligibility criteria
Inclusion criteria
- individuals aged over 17 years;
- mild to severe depressive symptoms.
Exclusion criteria
- cancer in the past 5 years;
- inability to perform the physical tests;
- prior diagnosis of muscle degenerative disease (e.g., myopathies, amyotrophic lateral sclerosis);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 2 centers
- University of Santo Amaro — São Paulo
- University Santo Amaro — São Paulo
Identifiers
NCT: NCT07007234 · 85919225.2.0000.0081