Sedentary Behavior and Depressive Symptoms

NCT ID: NCT07007234

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-07-01

Brief Summary

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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical activity intervention

Patients allocated to this arm will be submitted to intervention (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)

Group Type: EXPERIMENTAL

Physical activity intervention

Intervention Type: BEHAVIORAL

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.

Standard of care

Patients allocated to this arm will be submitted to intervention (4 face-to-face individual sessions during 4 months, lasting \~15-30 minutes, however they will receive general instructions related to WHO guidelines for physical activity.)

Group Type: EXPERIMENTAL

Standard of care

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

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);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hamilton Augusto Roschel da Silva

PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Santo Amaro

São Paulo, SO, Brazil

Site Status: RECRUITING

University Santo Amaro

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Saulo Gil

Role: primary

ssgil@prof.unisa.br

5511970273059

Saulo Gil

Role: primary

ssgil@prof.unisa.br

+551197027-3059

Other Identifiers

85919225.2.0000.0081

Identifier Type: -

Identifier Source: org_study_id