Clinical trial NCT05849792: Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project
Official title: Internet-based Physical Activities Randomized Controlled Trial in Patients With Mild/Moderate Depression: Effects on Psychological and Social Well-being: SONRIE Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Physical Fitness
Depression
Adult ALL
Psychological
Keywords: depression
physical activity
exercise
physical fitness
psychological
Endocannabinoids system
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Junta de Andalucia
name: Institute of Biomedical research and innovation of Cádiz (INIBICA)
First posted: 2023-05-09
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male and female participants between 25-65 years.
* Mild and / or moderate depression diagnosed by Beck Scale.
* Do not have other severe somatic or psychiatric disorders or other diseases that prevents physical activity.
* To be able to communicate with any problem.
* To be able to read and understand the main purpose of the study.
* Informed consent: must be capable and willing to provide consent.

Exclusion Criteria:

* Major depression diagnosed.
* Acute or terminal illness.
* History of cerebral infarction, epilepsy, brain tumor.
* Unstable cardiovascular disease, or other medical conditions.
* Upper or lower extremity fracture in the past 3 months.
* Severe visual or auditory problems.
* Unwillingness to either complete the study requirements or to be randomized into control or training group.
* To be a participant in another research study that may influence the present project.

Primary outcomes:
measure: Depression PRE
timeFrame: month 11-12
measure: Depression POST
timeFrame: month 18-19
measure: Depression RET
timeFrame: month 22-23
measure: Anxiety disorders and stress PRE
timeFrame: month 11-12
measure: Anxiety disorders and stress POST
timeFrame: month 18-19
measure: Anxiety disorders and stress RET
timeFrame: month 22-23
measure: Light physical activity PRE
timeFrame: month 11-12
measure: Light physical activity POST
timeFrame: month 18-19
measure: Light physical activity RET
timeFrame: month 22-23
measure: Moderate physical activity PRE
timeFrame: month 11-12
measure: Moderate physical activity POST
timeFrame: month 18-19
measure: Moderate physical activity RET
timeFrame: month 22-23
measure: Vigorous physical activity PRE
timeFrame: month 11-12
measure: Vigorous physical activity POST
timeFrame: month 18-19
measure: Vigorous physical activity RET
timeFrame: month 22-23
measure: Moderate-Vigorous physical activity PRE
timeFrame: month 11-12
measure: Moderate-Vigorous physical activity POST
timeFrame: month 18-19
measure: Moderate-Vigorous physical activity RET
timeFrame: month 22-23
measure: Cardiorespiratory fitness PRE
timeFrame: month 11-12
measure: Cardiorespiratory fitness POST
timeFrame: month 18-19
measure: Cardiorespiratory fitness RET
timeFrame: month 22-23
measure: 30-s chair stand PRE
timeFrame: month 11-12
measure: 30-s chair stand POST
timeFrame: month 18-19
measure: 30-s chair stand RET
timeFrame: month 22-23
measure: Chair sit and reach PRE
timeFrame: month 11-12
measure: Chair sit and reach POST
timeFrame: month 18-19
measure: Chair sit and reach RET
timeFrame: month 22-23
measure: Back scratch PRE
timeFrame: month 11-12
measure: Back scratch POST
timeFrame: month 18-19
measure: Back scratch RET
timeFrame: month 22-23
measure: Blind flamingo PRE
timeFrame: month 11-12
measure: Blind flamingo POST
timeFrame: month 18-19
measure: Blind flamingo RET
timeFrame: month 22-23
measure: 8 ft. up and go PRE
timeFrame: month 11-12
measure: 8 ft. up and go POST
timeFrame: month 18-19
measure: 8 ft. up and go RET
timeFrame: month 22-23
measure: Handgrip strength PRE
timeFrame: month 11-12
measure: Handgrip strength POST
timeFrame: month 18-19
measure: Handgrip strength RET
timeFrame: month 22-23
measure: Anandamine (AEA) PRE
timeFrame: month 11-12
measure: Anandamine (AEA) POST
timeFrame: month 18-19
measure: Anandamine (AEA) RET
timeFrame: month 22-23
measure: 2-araquinodilglicerol (2-AG) PRE
timeFrame: month 11-12
measure: 2-araquinodilglicerol (2-AG) POST
timeFrame: month 18-19
measure: 2-araquinodilglicerol (2-AG) RET
timeFrame: month 22-23
measure: N-palmitoylethanolamide (PEA) PRE
timeFrame: month 11-12
measure: N-palmitoylethanolamide (PEA) POST
timeFrame: month 18-19
measure: N-palmitoylethanolamide (PEA) RET
timeFrame: month 22-23
measure: N-oleylethanolamine (OEA) PRE
timeFrame: month 11-12
measure: N-oleylethanolamine (OEA) POST
timeFrame: month 18-19
measure: N-oleylethanolamine (OEA) RET
timeFrame: month 22-23
measure: Brain-derived neurotrophic factor PRE
timeFrame: month 11-12
measure: Brain-derived neurotrophic factor POST
timeFrame: month 18-19
measure: Brain-derived neurotrophic factor RET
timeFrame: month 22-23
Secondary outcomes:
measure: Ryff's Psychological Well-Being Scale (42-item) PRE
timeFrame: month 11-12
measure: Ryff's Psychological Well-Being Scale (42-item) POST
timeFrame: month 18-19
measure: Ryff's Psychological Well-Being Scale (42-item) RET
timeFrame: month 22-23
measure: The SF-36 Health Questionnaire PRE
timeFrame: month 11-12
measure: The SF-36 Health Questionnaire POST
timeFrame: month 18-19
measure: The SF-36 Health Questionnaire RET
timeFrame: month 22-23
measure: Blood pressure PRE
timeFrame: month 11-12
measure: Blood pressure POST
timeFrame: month 18-19
measure: Blood pressure RET
timeFrame: month 22-23
measure: Heart rate PRE
timeFrame: month 11-12
measure: Heart rate POST
timeFrame: month 18-19
measure: Heart rate RET
timeFrame: month 22-23
measure: Weight PRE
timeFrame: month 11-12
measure: Weight POST
timeFrame: month 18-19
measure: Weight RET
timeFrame: month 22-23
measure: Height PRE
timeFrame: month 11-12
measure: Height POST
timeFrame: month 18-19
measure: Height RET
timeFrame: month 22-23
measure: Waist circumference PRE
timeFrame: month 11-12
measure: Waist circumference POST
timeFrame: month 18-19
measure: Waist circumference RET
timeFrame: month 22-23
measure: Fat mass PRE
timeFrame: month 11-12
measure: Fat mass POST
timeFrame: month 18-19
measure: Fat mass RET
timeFrame: month 22-23
measure: Sociodemographic characteristics questionnaire PRE
timeFrame: month 11-12
measure: Sociodemographic characteristics questionnaire POST
timeFrame: month 18-19
measure: Sociodemographic characteristics questionnaire RET
timeFrame: month 22-23
measure: Food Frequency Questionnaire (FFQ) PRE
timeFrame: month 11-12
measure: Food Frequency Questionnaire (FFQ) POST
timeFrame: month 18-19
measure: Food Frequency Questionnaire (FFQ) RET
timeFrame: month 22-23
measure: Sleep time PRE
timeFrame: month 11-12
measure: Sleep time POST
timeFrame: month 18-19
measure: Sleep time RET
timeFrame: month 22-23
measure: The Pittsburg Sleep Quality Index PRE
timeFrame: month 11-12
measure: The Pittsburg Sleep Quality Index POST
timeFrame: month 18-19
measure: The Pittsburg Sleep Quality Index RET
timeFrame: month 22-23
Other outcomes:
Locations:
city: Puerto Real
country: Spain
facility: University of Cádiz
state: Cádiz
Study officials:
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