Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project

Summary

The goal of this randomized controlled trial is to determine the effect of an intervention program with physical activity for 12 weeks on depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression. The main questions it aims to answer are:

1. \- To determine the association of physical activity levels, sedentary behavior, sleep patterns, physical condition, diet, and general health status with mental and social well-being, and quality of life in a large sample of adult patients diagnosed with mild or moderate depression.
2. \- To examine the predictive capacity of physical activity, sedentary behaviors, and physical condition on mild and moderate depressive disorder.
3. \- To study the effect of a period without an intervention program with physical activity (8 weeks without exercise intervention) on the variables studied.
4. \- To examine the role of the endocannabinoid system on depression as well as its behavior after an intervention program of physical activity.

Participants will be involved in a physical activity intervention program for 12 weeks.

Researchers will compare intervention group and control group to see if an intervention program with physical activity for 12 weeks improve depression, social and emotional well-being and quality of life and health in adults with mild and moderate depression.

Conditions

• Exercise
• Physical Fitness
• Depression
• Adult ALL
• Psychological

Interventions

BEHAVIORAL

Exercise and psychological intervention

Physical Exercise Intervention Sixty-minute sessions were delivered via internet, three times per week (1 supervised) over the first four weeks of the COVID-19 home confinement. The intervention was a multicomponent exercise program lead by a specialist in fitness composed of aerobic, resistance, balance, coordination, mobility and stretching exercises. Each multicomponent exercise session consisted of a 10 min warm-up, 40 min of moderate to vigorous intensity physical activity, and 10 min cool down. Psychological intervention The internet-based-psychological intervention provided to different component of Cognitive Behavioral Therapy (CBT) guided and recorded by a sport neuro-psychologist specialist. The iCBT is based on the protocol for face-to-face CBT for depression. The program consisted of 4 weeks composed of 2 weekly video-guided sessions, with a maximum duration of 30 minutes. iCBT was focused on 4 main axes of action physiological, emotional, behavioral and cognitive.

Sponsors & Collaborators

• Junta de Andalucia

  collaborator OTHER_GOV

• Institute of Biomedical research and innovation of Cádiz (INIBICA)

  collaborator UNKNOWN

• University of Cadiz

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2020-02-28

Completion

2020-10-30

Countries

• Spain

Study Locations