Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project
Condition: Exercise; Physical Fitness; Depression; Adult ALL; Psychological
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

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.
    

Detailed description: 
      One hundred and six eligible participants between 25-65 years old (Spanish higher prevalence
      of depression in adulthood) diagnosed with mild or moderate depression will be the sample of
      this project. Participants will be recruited from the Mental Health Unit (UGC Salud Mental),
      covering different areas of the province of Cadiz (Spain) such as Puerto Real, Chiclana de la
      Frontera and Vejer de la Frontera. The Mental Health Unit Director from Puerto Real Hospital
      is a researcher associated with this project who has specific experience with clinical
      experience. He will be the person in charge for the clinical depression diagnosis. Moreover,
      participants will perform specific depression tests at the time of recruitment to confirm
      their clinical status. Individuals who meet the criteria to participate in this study will
      sign the informed consent previously to their inclusion in this project (see inclusion /
      exclusion criteria section).

      Sample size and statistical power

      Sample size determination will be estimated with a 5% type I error (α) and 95% confidence
      interval establishing a level of precision (d = 0.095) for the hypothesis test to comparing
      two proportions. The desired sample size will be n = 96 participants and it will be increased
      by 10% (n = 106) to compensate the possible dropout of participants during the evaluation
      process of the study. Sample size for the hypothesis test to comparing two means for the
      intervention study will consider with a significance level alpha of 0.05 and a power of 0.95
      (beta = 0.05) and considering the standard deviation for depression variable as 9.36
      (Bouldering psychotherapy reduces depressive symptoms even when general physical activity is
      controlled for: A randomized controlled trial, Heylon, 2018; Mar; 4 (3): e00580). In this
      way, to detect a minimum mean difference of 8.26 between control and experimental groups for
      the depression variable, it is estimated that the sample size of each group should be 30
      patients. Therefore, a total of 60 participants will be randomly recruited to each group
      balanced by sex, age and depression clinical severity. It should be taking into account that
      several simulations to estimate the sample size based on previous studies were performed by
      STATA statistical software vs. 14.0.
    

Intervention name(s): Exercise and psychological intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: depression; physical activity; exercise; physical fitness; psychological; Endocannabinoids system