ProtocolInternational Journal of Clinical Trials

Publication:
The effects of promoting mentally active sedentary behaviour and physical activity on depressive symptoms: a randomized controlled trial

Int J Clin Trials. 2026;13(2):194-203.DOI10.18203/2349-3259.ijct20261384

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Abstract

Background Depressive symptoms are linked to poorer health and higher mortality, partly due to non-communicable diseases. While sedentary behavior contributes to these outcomes, its impact may depend on cognitive engagement. Evidence from interventions replacing passive sedentary activities with active or physical alternatives remains limited. Objectives were to evaluate the effects of an intervention replacing mentally passive sedentary behaviors with mentally active sedentary behaviors, light physical activity, or moderate-to-vigorous physical activity on depressive symptoms in adults with subclinical depression.

Methods This single-center, parallel-group, randomized controlled trial will randomly allocate eligible participants (1:1) to either the intervention or control arm. The intervention group will engage in a 4-month goal-setting program designed to substitute mentally passive sedentary behaviors with mentally active sedentary behaviors, light physical activity, or moderate-to-vigorous physical activity. The control group will attend 4-month individual sessions and receive general guidance based on physical activity recommendations. Depressive symptoms (primary outcome), differentiated sedentary behaviors and physical activity levels, quality of life, body composition, and functional capacity will be evaluated at baseline and after the 4-month intervention. Data will be analyzed using an intention-to-treat approach to maintain randomization integrity, and per-protocol percentage changes will be compared using independent t-tests. All analyses will be conducted by a blinded researcher.

Conclusions This trial could yield new insights into the benefits of replacing mentally passive sedentary behaviors with mentally active alternatives, light physical activity, or moderate-to-vigorous physical activity for alleviating depressive symptoms in adults with mild to moderate depression. Trial Registration: This study is registered at ClinicalTrials.gov (identifier NCT07007234).

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Affiliations

  1. Department of Health Sciences, Santo Amaro University, Sao Paulo, Brazil
  2. Department of Psychiatry, Bipolar Disorder Program (PROMAN), University of São Paulo Medical School, São Paulo, Brazil; Department of Physical Education, Physical Activity, Sport and Mental Health laboratory (LAFESAM), Institute of Biosciences, São Paulo State University (UNESP), Rio Claro, São Paulo, Brazil
  3. Department of Sports Methods and Techniques, Federal University of Santa Maria, Santa Maria, Brazil; Faculty of Health Sciences, Universidad Autónoma de Chile, Providência, Chile
  4. Institute of Psychiatry, King’s Colege London, UK
  5. Laboratory of Assessment and Conditioning in Rheumatology, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, São Paulo, SP, Brazil; Center of Lifestyle Medicine, School of Medicine, University of Sao Paulo, Sao Paulo, SP, Brazil
  6. Department of Health Sciences, Santo Amaro University, Sao Paulo, Brazil; Laboratory of Assessment and Conditioning in Rheumatology, Hospital das Clínicas HCFMUSP, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, São Paulo, SP, Brazil; Center of Lifestyle Medicine, School of Medicine, University of Sao Paulo, Sao Paulo, SP, Brazil

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