Depression, AnxietyNCT07007234
Sedentary Behavior and Depressive Symptoms
A study testing Physical activity intervention in people with Depression, Anxiety, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Jun 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals aged over 17 years;
- mild to severe depressive symptoms.
Who cannot join
- cancer in the past 5 years;
- inability to perform the physical tests;
- prior diagnosis of muscle degenerative disease (e.g., myopathies, amyotrophic lateral sclerosis);
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
University of Santo Amaro
São Paulo, SO, 04829-300
Saulo Gil, 5511970273059, ssgil@prof.unisa.br
Saulo Gil
- Recruiting
University Santo Amaro
São Paulo, São Paulo, 04829-300
Saulo Gil, +551197027-3059, ssgil@prof.unisa.br
About this study
Official title: Sedentary Behavior and Depressive Symptoms: Influence of Specific Domains of Sedentary Behavior
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
- Being tested
- Physical activity intervention, Standard of care
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
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 careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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.) Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Secondary outcomes (11)
Anxiety Symptoms (primary outcome)
The anxiety symptoms will be assessed by Beck's Anxiety Inventory (BAI).Score ranges from 0 to 63 points, being higher scores indicative of higher symptoms of anxiety.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Indirect physical activity levels assessment
Indirect Physical activity levels will be assessed using the International Physical Activity Questionnaire-Long Form (IPAQ).
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Objective physical activity levels assessment
Objective measures of physical activity levels will be assessed using ActiGraph GT9X® accelerometers
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Indirect sedentary behavior assessment
Indirect levels of sedentary behavior will be assessed using the questionnaire LASA-SBQ (i.e., Longitudinal Aging Study Amsterdam - Sedentary Behavior Questionnaire).
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Objective sedentary behavior assessment
The objective measures of sedentary time will be assessed using ActiGraph GT9X® accelerometers.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Quality of life assessement
The quality of life will be assessed using the WHOQOL-bref. Score ranges from 0 to 100 points, being higher scores indicative of higher quality of life.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Body Weight
Body weight will be assessed on a calibrated digital scale.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Fat mass (kg)
Fat mass (kg) will be assessed using 4-point bioelectrical impedance device (hands and feet).
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Fat-free mass (kg)
Fat-free mass (kg) will be assessed using 4-point bioelectrical impedance device (hands and feet).
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (30-s Sit-to-stand Test)
The 30-second sit-to-stand test is a simple measure of lower body strength and functional capacity. Participants are asked to rise from a seated position and sit back down as many times as possible within 30 seconds. The total number of complete sit-to-stand repetitions performed in the given time is recorded. This test is commonly used to assess physical fitness and mobility, particularly in older adults or individuals with health conditions.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Muscle Function (Timed-up-and-go)
The Timed Up and Go (TUG) test is a simple and widely used assessment of mobility and balance. Participants are asked to stand up from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down again, all as quickly as possible. The total time taken to complete the task is recorded. The TUG test is commonly used to evaluate functional mobility, fall risk, and the ability to perform daily activities, particularly in older adults or individuals with mobility impairments.
Measured: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamilton Augusto Roschel da Silva, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007234
- Sponsor's protocol ID
- 85919225.2.0000.0081
- Status last verified
- Jul 2025
- First submitted
- 20 May 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Behavior and Depressive Symptoms: Influence of Specific Domains of Sedentary Behavior
- ClinicalTrials.gov ID
- NCT07007234
- Acronym / sponsor ID
- 85919225.2.0000.0081
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionPatients 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) |
| Standard of care | Experimental | Behavioral: Standard of carePatients 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- individuals aged over 17 years;
- mild to severe depressive symptoms.
Key exclusion criteria (3 listed)
- cancer in the past 5 years;
- inability to perform the physical tests;
- prior diagnosis of muscle degenerative disease (e.g., myopathies, amyotrophic lateral sclerosis);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionThe 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. | Behavioural | Physical activity intervention |
| Standard of careThe 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 | Behavioural | Standard of care |
Primary outcome
Depressive Symptoms
Time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
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.
11 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Depression, Anxiety, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.