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Clinical Trial Summary

The main objective of this project will be to verify if the insertion of diaphragmatic, cardiorespiratory and strength breathing exercises and cooperative sports activities in Physical Education classes, during a period of 12 weeks, may be able to modify the scores of symptoms of anxiety and depression in adolescent students. As secondary objectives, this project will seek to verify which of the interventions will provide the greatest reductions in students' anxiety and depression symptoms, as well as analyze their effects on other health indicators, also verifying if a greater volume of sessions can provide additional benefits to mental health. when compared to a smaller volume. This is an experimental study, of the randomized clinical trial (RCT) type. The target population will be adolescent students (14 to 19 years old) from the Federal Institute Sul-rio-grandense (IFSul) on the Bagé and Pelotas campuses. A total of 16 classes will compose the sample. The classes that have the Physical Education (PE) curriculum component in their schedule will be listed and randomized in relation to the comparator group (CG) and to the three different intervention protocols: diaphragmatic breathing exercises (intervention group 1 or GI-1), physical exercises cardiorespiratory and strength activities (intervention group 2 or GI-2) and cooperative sports activities (intervention group 3 or GI-3). The application of these interventions will occur during PE classes, twice a week at Campus Bagé and three times a week at Campus Pelotas. Interventions will last 15 minutes in groups GI-1 and GI-2, and 20 minutes in GI-3. Before the start of the intervention, baseline assessments will be carried out, consisting of primary outcomes (symptoms of anxiety and depression) and secondary outcomes (self-concept, quality of life, sleep indicators, self-perception of physical fitness, cognitive failures, strength and cardiorespiratory fitness). The groups will be compared regarding the characteristics collected at baseline and after the 12th week of intervention. The Generalized Estimating Equations (GEE) and the post-hoc Bonferroni test will be used to compare the moments (pre and post-intervention) between the groups and to identify the group*moment interaction. Analyzes will be performed by protocol and by intention to treat. The significance coefficient adopted will be p<0.05.


Clinical Trial Description

General objective To evaluate the effects of interventions with diaphragmatic breathing exercises, cardiorespiratory and strength exercises, and cooperative sports practices on anxiety and depression symptoms in adolescents during high school physical education classes. Specific - To compare the effects of interventions with diaphragmatic breathing exercises, cardiorespiratory and strength exercises and cooperative sports practices on students' anxiety and depression symptoms; - Analyze the effect and compare the interventions carried out in relation to the different health indicators: Quality of life, Sleep indicators, Self-concept, Self-perception of physical fitness, Cognitive failures, Strength (maximum, resistance and power) and Cardiorespiratory fitness; - Verify and compare the effect of interventions with different weekly volumes (twice a week and three times a week) on students' anxiety and depression symptoms, as well as on the secondary outcomes analyzed. Target Population and Sample The target population will be integrated high school students from the Federal Institutes of Rio Grande do Sul. The study sample will be composed of students (14 to 19 years old) of the integrated high school of the Federal Institutes of Sul-rio-grandense (IFSul) Campus Pelotas and Bagé. Sample characterization variables demographic indicators - Gender identity; - Age; - Marital status; - Skin color. Socioeconomic indicators - Socioeconomic level through monthly family income (BRL); - Campus you study; - Course and year/semester attended. Anthropometric indicators - Body mass (kilograms); - Height (meters); - Body Mass Index (BMI). Clinical indicators - Previous clinical diagnosis of anxiety or depression disorder in the student; - History of any diagnosed anxiety disorder in the family (father/mother); - History of any diagnosed depressive disorder in the family (father/mother); - Use of continuous use of anxiolytic; - Use of continuous use antidepressant; - Need for psychological or psychiatric follow-up in the last 12 months; - Current psychological or psychiatric follow-up. Control variables - Level of physical activity; - Screen time; - Habitual practice of physical activity. Instruments Anxiety Symptoms: Anxiety symptoms will be collected using the General Anxiety Disorder-7 (GAD-7) instrument. The General Anxiety Disorder-7 (GAD-7) instrument seeks to assess and monitor anxiety symptoms. Depressive symptoms: To assess depressive symptoms, the Patient Health Questionnaire-9 (PHQ-9) instrument will be used, which seeks to assess and monitor depressive symptoms. Self-concept: This assessment will be obtained through the Multidimensional Self-Concept Scale (AF-5). Quality of Life: For the assessment of quality of life, the instrument World Health Organization Quality of Life (WHOQOL) abbreviated version, proposed by the World Health Organization. Self-perception of physical fitness: For the assessment the self-perception of physical fitness will be used the Physical Fitness Questionnaire (International Fitness Scale - IFIS). Cognitive Failures: For the assessment the cognitive failures will be used the Cognitive Failures Questionnaire (CFQ). Physical activity level: The instrument to measure physical activity will be the International Physical Activity Questionnaire (IPAQ), short version, proposed by the World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC). Screen time: The variable "sedentary screen time" during leisure will be evaluated by the time of hours per day in which the person uses television, computer, tablet, cell phone and video game, in the face of a posture that implies low energy expenditure , such as sitting or lying down. Habitual practice of physical activity: This variable will be analyzed through simple questions, such as "Do you currently practice any type of physical activity regularly? If yes, describe which one(s)."; "Is this physical activity performed under the supervision of a professional (teacher/technician)?"; "Where do you practice this physical activity?"; "Do you participate in competitions with this physical activity?". The mentioned questions aim to investigate the habitual practice of physical activities, the type, presence of supervision, location and purpose of these practices. Body Mass Index: The body mass index (BMI) will be calculated by the body mass (Kg) measured, divided by the height (in meters) squared. Strength: The maximum muscular strength will be measured through the handgrip strength by a hydraulic dynamometer. The power of lower limbs will be evaluated through the horizontal jump test. Endurance strength will be measured by the 1-minute abdominal endurance test. Cardiorespiratory fitness: Cardiorespiratory fitness will be assessed through the 20m back and forth test. Demographic variables To collect information regarding demographic variables, the respondent will be asked to do the following: - Tick one of the options in the gender question. - Fill in your current age in complete years; - Tick one of the options in the marital status question; - Tick one of the options in the skin color question. Socioeconomic indicators For the collection of information regarding the socioeconomic variables, the respondent will be asked the following: - Fill in the total monthly family income (BRL); - Fill in the campus where you study (Bagé or Pelotas); - Fill in the year or semester of the course you are enrolled and attending. The courses are as follows: agriculture, information technology, visual communication, interior design, buildings, electromechanics, electronics, electrotechnical and chemistry. Anthropometric indicators To verify the anthropometric indicators, measurements of body weight (in kg) and height (in cm) will be performed. Body weight will be obtained using a scale, and students will be instructed to wear light clothes and be barefoot. Height will be measured using a stadiometer attached to the aforementioned scale. Clinical indicators Student or family history of anxiety or depression disorder (parent); The history of anxiety or depression disorder in the student or in the father and/or mother will be collected through a closed question in which it will be asked if the student has a clinical diagnosis of anxiety or depression disorder and if any family member (father/mother) is or has been diagnosed with some form of anxiety disorder or depressive disorder. If positive in any of the questions, specify which disorder. Drug intake Continuous use drugs will be collected through a closed question in which the person will be asked if the person uses anxiolytic or antidepressant drugs of continuous use and, if so, the name of these drugs and the doses ingested. Psychological or psychiatric support Two questions will be made available about the need for some psychological or psychiatric follow-up. The first addressing whether there was psychological or psychiatric follow-up in the last 12 months and the second whether this service is currently needed. Data analysis Initially, the numerical variables will be analyzed in relation to the normality of their distributions using the Shapiro-Wilk test. The description of numerical variables will be performed by the mean and standard deviation (sd) or median and interquartile intervals. The description of the categorical variables will be performed by the absolute (n) and relative (%) frequencies. To compare the characterization variables between the groups, ANOVA and the chi-square test will be used for numerical and categorical variables, respectively. Generalized Estimating Equations (GEE) and Bonferroni's post-hoc test will be used to compare moments (pre and post-intervention) and between groups to identify the group*moment interaction. Analyzes will be performed by intention to treat and by protocol. In intention-to-treat analyses, all participants will be included. Participants who do not present consistent data in at least one of the moments (pre and/or post-intervention) and those students who present any of the aforementioned exclusion criteria will be removed from the protocol analyses. It will also be verified the effect size amplitude through Cohen's "d", obtaining the classification: insignificant (≤0.19) small (0.20 to 0.49); medium (0.50 to 0.79); large (0.80 to 1.29) and very large (≥1.30), according to Cohen (1988) and Rosenthal (1996). The significance level adopted will be 5% for all statistical analyses. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05561192
Study type Interventional
Source Federal University of Pelotas
Contact
Status Not yet recruiting
Phase N/A
Start date February 1, 2023
Completion date December 31, 2023

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