Sedentary Behavior and Depressive Symptoms

NCT07007234 | Recruiting

• 1 other identifier: 85919225.2.0000.0081
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms

  The depressive symptoms will be assessed by Beck's Depressive Inventory (BDI). Score ranges from 0 to 63 points, being higher scores indicative of higher symptoms of depression.

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

Secondary Outcomes (11)

• Anxiety Symptoms (primary outcome)

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Indirect physical activity levels assessment

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Objective physical activity levels assessment

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Indirect sedentary behavior assessment

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

• Objective sedentary behavior assessment

  Baseline (Pre-intervention) and 16 weeks (Post-intervention)

Study Arms (2)

Physical activity intervention

EXPERIMENTAL

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)

Behavioral: Physical activity intervention

Standard of care

EXPERIMENTAL

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.)

Behavioral: Standard of care

Interventions

Physical activity intervention 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.

Physical activity intervention

Standard of care 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

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals aged over 17 years;
• mild to severe depressive symptoms.

You may not qualify if:

• cancer in the past 5 years;
• inability to perform the physical tests;
• prior diagnosis of muscle degenerative disease (e.g., myopathies, amyotrophic lateral sclerosis);

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

University of Santo Amaro

São Paulo, SO, 04829-300, Brazil

RECRUITING

University Santo Amaro

São Paulo, São Paulo, 04829-300, Brazil

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 5, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

BR (2)